Archive for the ‘Osteoporosis’ Category

08.06.10

WARNING: Don’t Take Fosamax or Boniva

As cute as Sally Fields is, she is not a doctor, she’s just an actress who is getting paid to advertise a drug. Now it appears that her radio and TV ads for Boniva, which is similar to Fosamax, may need to add a new WARNING: “Tell your doctor if your femur snaps in half while you’re just standing in the kitchen doing nothing.”

This of course would have to be added to the already worrisome list of side-effects that are recited so fast that you can’t really comprehend them anyway.

The other previously known side-effects include the following: “Don’t take Boniva if you have low blood calcium, severe kidney disease, or you can’t sit or stand for at least one hour.” (because it could wear a hole in your stomach, or cause cancer of your esophagus).

“Stop taking Boniva and tell your doctor if you have difficult or painful swallowing, chest pain, or severe or continuing heartburn, as these may be signs of serious upper digestive problems.” (like an ulcer or Osteonecrosis of the Jaw, which is the disintegration of bone in your jaw)

“If severe bone, joint and/or muscle pain develops tell your doctor.” (this could be a sign that the drug you’ve been taking for five years or more has actually stopped your bones from remodeling as they should every year and now you’ve got new bone on top of the old brittle bone that has become so heavy that it’s now about to snap in two and perhaps cause more severe problems sooner than would have resulted had you never taken the drug at all)

Watch the Boniva ad with Sally Field on the player below. Remember the age old saying, “If it sounds too good to be true, it probably is.”

The truth is that diet and exercise along with balancing your hormones is the only way to truly prevent and reverse Osteoporosis.

To learn more about the best way to prevent, test and treat Osteoporosis naturally, click here.

07.06.10

Osteoporosis Drugs Causing Fractures & Cancer! What Can You Do?

On March 8, 2010, ABC News reported that “Osteoporosis Drugs, Like Fosamax May Increase Risk of Broken Bones in Some Women” and that “Long-term Use of Popular Class of Osteoporosis Drugs May Have Opposite Effect for Some Women.” (click here to watch the ABC video)

Fosamax and Boniva are the two most popular drugs in this class of drugs called bisphosphonates. They are supposed to make bones stronger, but now there’s mounting evidence that, for some women, taking these medications for more than five years could cause spontaneous fractures.

“We are seeing people just walking, walking down the steps, patients who are doing low-energy exercise,” said Dr. Kenneth Egol, professor of orthopedic surgery at NYU Langone Medical Center. “Very unusual, the femur is one of the strongest bones in the body.”

This entire class of drugs should be withdrawn from the market, says Dr. Hansen. On January 1, 2009, the New England Journal of Medicine published a report from the FDA, which says that the Osteoporosis drug Fosamax may now be linked to cancer. The FDA received 23 reports of esophageal cancer possibly linked to the drug between its October 1995 debut and May 2008. Of these patients, eight have died so far, according to the report. This is worrisome news for the tens of millions of American women that currently take Fosamax for Osteoporosis.

Good News! There are safe and effective Natural Alternatives to drugs like Fosama & Boniva

Osteoporosis affects approximately 25 million Americans. Women know they need to do something to prevent Osteoporosis, but they don’t know what. They are trusting their doctors and the drug companies to give them something to help. Most doctors know nothing about prevention through diet, nutrition and exercise. So by the time the average woman is diagnosed with Osteoporosis, 50 to 75% of her original bone mass has already been lost. Women need answers. Why is Osteoporosis so prevalent in the U.S., while it is almost unheard of in some cultures? What can a woman do to change her risk of getting this common disease without taking risky drugs?

Officials estimate that there are about 1.5 million fractures annually among osteoporosis patients and 300,000 of them die within six months of getting a fracture. Medical costs for osteoporosis treatment exceed $17 billion dollars annually in the U.S. and because of the increasing elderly population, the number is only expected to rise. The incidence of these bone fractures has doubled in the last 30 years, due mainly to nutritional and environmental factors.

Conventional medicine views osteoporosis as an irreversible process associated with aging and menopause rather than diet and lifestyle choices. The emphasis has been placed on slowing down the rate of bone loss by prescribing synthetic drugs that block bone loss, as well as high doses of calcium, increased amounts of dairy and regular exercise. While these therapies do slow the rate of bone loss in some, they do not stimulate bone rebuilding. The best they can do is to keep the already porous bones from losing any more bone density.

The good news is that Osteoporosis is preventable and reversible through diet, exercise, nutritional supplementation and natural bio-identical hormone replacement with plant based Estriol and Progesterone, and natural Growth Hormone precursors.

Dietary Treatment and Prevention of Osteoporosis

Observations of various populations worldwide show that the countries with the highest consumption of meat and dairy products have the highest incidence of Osteoporosis. Because of this observation, scientists posed this question: Is osteoporosis due to calcium deficiency or excess protein, or acid pH caused by too much protein and dairy?

A study published in the journal Nutrition in 1974, found that eating a low protein diet led to a positive calcium deposit of +31, while a high protein diet led to a calcium loss of -120. This means that at the end of the day, after taking 500 mg of calcium, the low protein diet group was shown to have increased its calcium level by +31. On the other hand, taking 500 mg of calcium while eating a high protein diet actually lowered the level of calcium in the bloodstream by -120.

Epidemiological studies from around the world have shown that in countries like Thailand, Laos, Cambodia, etc, where the people generally eat no dairy at all and less than 50 grams of protein daily and get about 400 mg of calcium per day in their diet, have no osteoporosis; it’s virtually unheard of in those countries. However, if you look on the other extreme, Eskimos who daily consume about 2200 mg of calcium, have the highest incidence of osteoporosis of any population in the world, even though they’re getting 2200 mg of calcium daily. The difference is that they also daily consume 250 to 400 grams of protein in fish, walrus, or whale meats. That high protein content and the acid pH that results are the principal causes of osteoporosis. It’s not simply a deficiency of calcium. It’s the excessive amount of protein that stimulates a hormonal change in the body that causes the body to excrete calcium through the kidneys in the urine.

The average American consumes as much as 100 grams of protein per day and that amount stimulates the parathyroid gland to release a hormone called parathormone that pulls calcium out of the bones to be excreted in the urine. The most important consideration in the prevention of Osteoporosis is not overdoing protein. This can be accomplished by following the Department of Agriculture’s new food pyramid guide. Start at the bottom: eat 6-11 servings of whole grains, 3-5 servings of fresh, steamed, or microwaved vegetables, and 2-3 servings of fresh fruits daily. Meats and dairy should be eaten sparingly in smaller portions than the former foods that are lower in the pyramid. For optimal health you only need a maximum of 40-50 grams of protein daily.

Minerals and Vitamin Cofactors

Calcium is the major mineral in bones. However, you can get too much of a good thing. If you’re eating a high protein diet, even 2200 mg of calcium a day won’t help you. Too much calcium inhibits magnesium, which is essential to the production of the hormone calcitonin. This hormone helps tone down the calcium excretion and keeps calciumGrapes bunch purple in the bones. Magnesium is also essential for the conversion of the active form of vitamin D, which is required for calcium absorption and its deposit into bone. Taking too much calcium actually blocks magnesium and therefore blocks the production of vitamin D in its active form, which prevents calcium from getting into the bone. Calcium should not be taken in excessive amounts.

There are several other nutrients that are very important in prevention and cure of osteoporosis. Three B-vitamins, vitamin B6, folic acid, and vitamin B12 are essential. These three vitamins are important in the conversion of the amino acid methionine into cysteine. If they are deficient, homocysteine increases. As homocysteine increases in the body it interferes with collagen cross-linking, leading to defective bone matrix. That means, if you don’t have these vitamins, then the bones can’t hold calcium in place in their normal meshwork. Therefore, even though you may be consuming enough calcium, it won’t be held in the bone.

Another vitamin that is often overlooked in the prevention and treatment of osteoporosis is vitamin K. This hormone-like vitamin is necessary for the production of the active form of osteocalcin which is the major noncollagen protein in the bone. Without sufficient vitamin K and its production of active osteocalcin, calcium will not be held within the bone in its place. Vitamin K is found in deep green leafy vegetables and is one of the most commonly deficient vitamins missing from our diet.

The trace mineral Boron also appears to be an essential factor in the prevention and treatment of osteoporosis. A study of postmenopausal women given 3 mg of boron daily was shown to reduce their urinary calcium loss by 44%. Apparently, boron is required to activate certain hormones including estrogen and vitamin D. Fruits and vegetables are the main sources of boron and diets that are deficient in these foods may also be deficient in boron.

Plant Cofactors

Certain bioflavonoids found in fruits have been shown to be very important in the prevention of osteoporosis. Certain polyphenol bioflavonoids, especially those extracted from grape seeds, have been shown to stabilize collagen structures. Since collagen is the major protein constituent in bone, stabilization of the integrity of the bone structure or the collagen will help to prevent calcium loss and osteoporosis. For optimal insurance against osteoporosis, I recommend taking a supplement that contains Leucoslect® Grape Seed Extract.

Drug Therapies

In July 2002, researchers at the National Institutes of Health abruptly halted the nation’s largest study on Hormone Replacement Therapy (HRT), because the study found that the long-term use of synthetic estrogen and synthetic progesterone drugs increase a women’s risk of breast cancer by 26%, her risk of a heart attack by 29%, her risk of stroke by 41% and her risk of blood clots by 113%. (Source: JAMA. 2002;288:321-333).

Several other drugs are now being recommended for Osteoporosis, including the Biphosphanate drugs that include Fosamax, Boniva and Actonel. Tens of millions of women are currently taking Fosamax for Osteoporosis and millions of additional women take Boniva and Actonel, all of which share the same concern.

Evista, a Selective Estrogen Receptor Modulator (SERM) is also being recommended to prevent and treat Osteoporosis. Evista is approved for the prevention and treatment of osteoporosis, but works by a different mechanism than the Biphosphanates. Evista stimulates the Estrogen Receptors and appears to prevent bone loss in a manner similar to other synthetic estrogens, like Premarin. Side effects include hot flashes, leg cramps and blood clots.

Natural Bio-Identical Hormone Replacement

The ovaries produce three different Estrogens: Estrone (E1), Estradiol (E2) and Estriol (E3). The two most concentrated and most potent estrogens are Estrone (E1) and Estradiol (E2). These two are both now classified as carcinogens. You should test your estrogen levels to make certain these two are not too high. Even “Bio-Identical” Hormone Replacement Therapy that uses Estradiol or Estrone can and does cause cancer if it gets to high.

Dr. Hansen’s Natural Hormone Rx: Estriol, Progesterone and Growth Hormone

Estriol (E3) has been shown to be protective against cancer. It prevents bone loss, stops hot flashes, thinning of the skin and dryness of the vaginal membranes. It is 1000 times less stimulating to the breast tissue than Estradiol and does not cause harmful build-up of the uterine lining. Estriol inhibits osteoclasts in bone from breaking down and causing bone loss.

Unlike the estrogens, which only help prevent bone loss, taking natural Progesterone helps to increases bone mineral density by as much as 10-15% within 6 months and 20-25% in 3 years (Clinical Nutrition Review, 1990, 10:384-391). Progesterone stimulates osteoblasts in the bone to directly increase bone density.

Growth Hormone (GH) is necessary throughout life to keep your bone density high. GH has direct effects on bone cells known as chondrocytes. A deficiency of GH severely limits bone growth and hence the accumulation of bone mass. You can stimulate you own GH activity by exercising and by getting plenty of sleep. Additionally,

Dr. Hansen prescribes a plant based source of Estriol and Progesterone for the prevention and treatment of Osteoporosis. He also prescribes a nutritional and herbal supplement known as Secretropin to boost GH production by the body. These natural products are safe and effective alternatives to synthetic drugs, providing all of the benefits and more, without the negative side-effects.

Testing

DEXA Scan X-Ray

The top standard for measuring bone density is the DEXA Scan, which is an X-Ray of the spine and the hip bone. The measurements taken can be compared to the average for the total population and by age group. The main concern with this test is the fact that it exposes you to gamma radiation that is known to be cancer inducing. For this reason I prefer to recommend an NTX Urine Test for bone density.

N-Telopeptide (NTX) Bone Loss Testing

Approximately 90% of the meshwork or your bones consists of type I collagen that is cross-linked at the N-terminal, hence the name N-Telopeptide. This highly cross-linked collagen structure provides for the basic fabric and tensile strength of bone tissue. The collagen infrastructure of bone undergoes a continuous process of remodeling that involves osteoclast mediated bone breakdown and osteoblast mediated bone formation. Bone breakdown by osteoclasts results in the release of cross-linked N-telopeptides (NTX)of type I collagen. NTX is specific to bone and is found in urine as a stable end product of bone loss.

Levels of NTX correlate with the rate of bone loss. Bone loss rates exceeding bone formation results in a net loss of bone and ultimately osteopenia or osteoporosis. This test is the best way to detct active bone loss or bone building. It is relatively inexpensive compared to the DEXA Scan and free of radiation.

Hormone Testing

All three Estrogens can be measured in Saliva, which gives an accurate assessment of the active forms of the estrogens. Progesterone is also tested in the Saliva. The Estrogen to Progesterone ratio gives a good picture of the relative balance of these two synergistic hormones. Too much Estradiol and Estrone or too little Estriol can cause an increased risk of cancer. Too little Progesterone will inhibit the production of new bone.

Growth Hormone is tested by blood. Because GH is released in short pulsatile bursts in the bloodstream and has a very short lifespan in the blood it is not a good marker for GH activity. Instead, we use IGF-1 to assess the correct level of GH. Ideally, IGF-1 level should be 200-250.

Vitamin D3 (25-Hydroxycalciferol) should be tested in the blood serum. Many experts recommend that the optimal Vitamin D3 level for prevention of osteoporosis and protection against cancers is 50-65 ng/ml.

Recommended Bone Building Supplement: Peak Advantage High Potency Multi-Vita/MinPeak Advantage Multi-Vitamin

  • Calcium Citrate: Calcium is the major mineral in bones. Calcium Citrate is 2.5 times better absorbed than Calcium Carbonate, even in individuals with low stomach acid. The U.S. RDA for calcium is based on 1968 data using Calcium Carbonate as the standard. According to more recent research published in The Journal of Clinical Pharmacology in November 1999, by Howard J. Heller, MD and his colleagues found that Calcium Citrate is 2.5 times more bioavailable (easier for your body to use) than Calcium Carbonate as demonstrated by measuring the blood level of calcium after a single oral dose (500 mg) of calcium carbonate taken with a meal.

The RDA used to be 800mg of Calcium Carbonate daily for women, which would be equivalent to only mg 320mg of Calcium Citrate. Adequate intake (AI) recommendations published in August 1997 were set at 1000 milligrams for men and women aged 19 - 50 and 1200 milligrams for individuals older than age 50. To get the equivalent benefit from Calcium Citrate you only need to consume 400 to 480mg of Calcium Citrate respectively.

  • Magnesium Aspartate: Magnesium is the determining factor of bone strength. 80-85% American women consume less than the RDA. Necessary for the formation of new calcium crystals and the active form of Vitamin D. Magnesium Aspartate is the most useable form.
  • Boron: Necessary for the production of natural estrogen and testosterone. Significantly reduces loss of calcium and magnesium.
  • Vitamin K: Required for the attraction of calcium to bones. Individuals with Osteoporosis have been found to have 35% less Vitamin K than age matched controls. Overuse of antibiotics kills healthful intestinal flora that produce Vitamin K. Supplementation reduces calcium loss by as much as 18-50%.
  • Vitamin D increases calcium absorption, slows bone loss and boosts bone formation. One study on Vitamin D showed that participants who took vitamin D supplements had a 7 percent lower risk of death compared to those that did not. It is now known that virtually every cell in our body has receptors for vitamin D and that vitamin D is not just a vitamin. It also has very powerful hormonal activities and has protective effects noted against certain cancers (particularly breast and prostate), autoimmune diseases like multiple sclerosis and type 1 diabetes, and heart disease. I recommend taking 5000 I.U.s once or twice daily. This is a quantity sufficient to raise your blood level of Vitamin D3 to between 60-100 ng/dl.
  • Folic Acid: Decreases homocysteine levels which can cause osteoporosis. Alcohol and Birth Control Pills cause a deficiency. Pregnancy creates a higher demand.
  • Silica: Found in high concentrations at calcification sites in growing bones.
  • Betaine HCl: Source of hydrochloric acid that is essential for the absorption and assimilation of minerals.
  • DigeZyme: Plant enzymes that digests phytates, found in grains that commonly bind to minerals and significantly reduce their availability for absorption.
  • GSE Ultra 110: Leucoselect® Grape Seed Extract to stabilize collagen.

Summary

Osteoporosis is preventable and it is reversible. You can take charge of your own health. For optimal results you need to eat more vegetables and grains and less meat and dairy products. The greatest threat to your bones is the high protein diet consumed in the United States. The average American consumes 90 grams of protein daily. You need to cut that amount in half. Additionally, you need a good multi-vitamin and mineral formula, like Peak Advantage that provides the right amount of minerals, vitamins and plant cofactors to prevent or reverse osteoporosis. Finally, you need to test your Estradiol, Estrone, Estriol, Progesterone and IGF-1 levels. With this information you can then correct the hormone imbalances and prevent or reverse Osteoporosis for good.

07.06.10

Osteoporosis Drugs Causing Bone Breaks: Patients Speaking Up

Why has the FDA moved so slowly on this issue. Bisphosphonates as a class of drugs should be taken off of the market immediately.

Fosamax and femur fractures : FDA is investigating possible links

By Mary Rice Tuesday, March 9th, 2010

Original Source: http://personalmoneystore.com/moneyblog/2010/03/09/fosamax-and-femur-fractures-fda-investigating/

The femur is one of the strongest bones in the body. Image from Flickr.

A connection between Fosamax and femur fractures is currently under investigation by the FDA. Fosamax is a drug intended to treat bone weakness, though some doctors have been noticing a possible connection to Fosamax and fractured bones. The Medicine and Healthcare Regulatory Agency out of the UK published information in March of 2009 about the “atypical stress fractures” in patients taking Bisphosphonates such as Fosamax.

What is Fosamax?

Fosamax is a drug intended to treat osteoporosis – the weakening of bones that happens due to age or lack of certain nutrients. These drugs work kind of like short term installment loans – they shut down the cells that cannibalize bone tissue, which strengthens the bone. It’s a member of the class of drugs called “bisphosphonates.”

How are Fosamax and femur fractures connected?

However, just like an installment loan, this bone has to eventually be paid back to the body. Dr. Robert Bunning, a rheumatologist at National Rehabilitation Hospital in Washington DC theorizes that extended use of these drugs (over 5 years) lead to “frozen bone” syndrome, where the bones are so dense they become very brittle.

What is the FDA doing about the connection between Fosamax and femur fractures?

The FDA has stated that it is “aware of and investigating” the connection between taking Fosamax and femur fractures. It has not yet presented any study results or required a warning to patients and doctors. In the past, though, the FDA has put out safety reviews of the bisphosphonate drug class that include warnings about severe bone and joint pain that can be caused by these drugs.

What if I take Fosamax?

If you currently take Fosamax or any other bisphosphonate drug, you should first and foremost talk to your doctor. Osteoporosis, the condition Fosamax is intended to treat, can be very dangerous if left untreated. The FDA and the company that makes Fosamax have yet to come out with any definitive studies on connections between Fosamax and femur fractures, so you should make a decision based your opinion and that of your doctor.

Comments

Patricia O’Dea says: April 24, 2010 at 6:05 am

Hello–
I have been on Fosamax for probably 6 or 7 years. I have osteoporosis and R.A. I am on methotrexate and a low dose of prednisone for my R.A. After hearing the report on fractures due to Fosamax, I went to my general doctor who said to stop taking it. I also consulted my rheumatologist, who said I should stay on it due to my osteoporosis. Whom am I to believe?? I am totally confused and have been off of it for a month, but I am torn in my decision.

I fell a year ago and fractured both bones in my arm, requiring two surgeries to put in a new radial head and a plate to secure the bones. So, I know I am susceptible to fractures. I am so careful now, walking very trepidly, wanting to avoid any more mishaps. I hope someone finally clarifies this issue!

Jeffrey Dach MD says: March 23, 2010 at 3:53 pm

The 2010 AAOS meeting which presented studies from the Hospital for Special Surgery (HSS) and Columbia University Medical Center which showed that Fosamax disturbs bone formation, and implicated Fosamax in spontaneous mid-femur fractures (without trauma).

Clarita Odvina MD reported nine cases of spontaneous femur fracture on Fosamax. Dr. Goh, a doctor in Singapore, identified nine more cases in his 2007 report of subtrochanteric femur fractures with minimal trauma in women on long term Fosamax. Joseph M Lane MD reported 15 cases of spontaneous femur fracture in women on Fosamax with a unique radiographic pattern.

Perhaps we should re-evaluate a drug that causes spontaneous mid femur fractures, jaw necrosis, and diffuse bone and joint pain. You don’t need a double blind placebo controlled study to show a drug disturbs bone physiology. The bone histology slides don’t lie.

jeffrey dach md

Linda Blackburn says: March 23, 2010 at 5:37 am

My 95 yr old Mother just broke her femur just below the hip. She has been on Fosamax for years. She had to go through a very difficult surgery & probably endless rehab. They put a long rod & screws & is living on strong pain mecication. She had a light fall on the carpet which should not have caused such a break. A week prior to this fall, she had been at her sewing machine & had made 24 hot pads for gifts. Now all she can do is lay in a bed & sometimes sit up to eat.

Jeffrey Dach MD says: March 22, 2010 at 5:21 pm

Dear Dr Lynch,

Perhaps you should also be calling insanely irresponsible the 2010 AAOS meeting which presented studies from the Hospital for Special Surgery (HSS) and Columbia University Medical Center which showed that Fosamax disturbs bone formation, and implicated Fosamax in spontaneous mid-femur fractures (without trauma).

Perhaps you should also be calling reckless, biased and irresponsible Clarita Odvina MD who reported nine cases of spontaneous femur fracture on Fosamax. Or Dr. Goh, a doctor in Singapore, who identified nine more cases in his 2007 report of subtrochanteric femur fractures with minimal trauma in women on long term Fosamax. Or Joseph M Lane MD who reported 15 cases of spontaneous femur fracture in women on Fosamax with a unique radiographic pattern.

Rather, I would say it is insanely irresponsilbe to give women a drug that causes spontaneous mid femur fractures, jaw necrosis, and diffuse bone and joint pain.

You don’t need a double blind placebo controlled study to show a drug disturbs bone physiology. The histology slides don’t lie.

Conflict of interest? That is a laugh. Drug companies clean up on Fosamax,a 3 billion dollar industry. Now that kind of money can generate a real conflict of interest, documented by Aubrey Blumsohn MD who blew the whistle on the Actonel studies.

jeffrey dach md

Bonnie Hay says: March 22, 2010 at 7:59 am

3/22/2010 Real life incidents do count! 10 years ago (I was 48) I had a spontaneous hip fracture (while being treated for what doctors thought was a back problem). After surgery I was put on Fosamax and have been on it for the past 10 years. 3 years ago I was walking out to my car and again experienced a spontaneous mid thigh displaced femur fracture. I had been experiencing months of pain in my hip and thigh and the doctors felt the hardwear from my previous surgery needed to come out. Unfortunately before that could happen my femur broke (8 hours in surgery). I continue to have a great deal of pain on my right side along with the fear of this happening again – I will be very interested in the final findings.

Jorge Anglin says: March 18, 2010 at 6:36 pm

I am truly appalled it is absurd that nothing has been done about this drug that has been allegedly linked to causing femur fractures. My mother just had an operation on her hip and she sustained an femur fracture and she was taking fosamx prior to the surgery had I had known she would possibly had been at risk of having her femur fractured the surgery would have most likely not have taken place. Please send me more information regarding this potentially dangerous medication

Terri Lewis says: March 12, 2010 at 11:43 am

I am going through the same hell. My femur broke spontaneously while standing on a sidewalk in Spain on June 6, 2008. It was a complete shearing of the leg. I am still on a cane and still in therapy nearly two years later. I was on Fosamax for 11 years prior to the break–and just as a preventive measure since my bone densities were low normal. Now FDA has investigated and has concluded that there is no firm evidence supporting the association between bisphosphomates and femur fractures. I don’t believe it!!

Jeffrey Dach MD says: March 11, 2010 at 4:21 am

Fosamax, A Drug in Litigation, Under FDA Review

The Fosamax (Alendronate) study done for FDA approval failed to show any benefit for the majority of the worried well, which is the osteopenia group defined as T score greater than -2.5. This Osteopenia Group actually had higher fracture rates than placebo. This data was data published by Cummings in JAMA in 1998 Fracture Intervention Trial.

Bisphosphonate drugs like Fosamax have severe adverse side effects of jaw necrosis (OJN), spontaneous mid-femur fracture, heart rhythm disturbances, and severe bone and joint pain.

The spontaneous mid femur fractures are especially troubling, since these are spontaneous fractures without any trauma. Subtrochanteric fractures are pathological fractures, indicating the underlying bone matrix is abnormal. This anormal weakening and brittleness is directly caused by the bisphosphonate drug.

Bottom Line: These are BAD drugs that actually make the bones weaker not stronger, and they should be banned by the FDA . However, knowing the FDA which is in the pocket of the drug companies, no action will be taken until many more women victims suffer from these drugs, and many more cases work their way through drug litigation court..

S.Lynch MD says: March 16, 2010 at 8:45 pm

Dear Dr. Dach:

What an INSANELY IRRESPONSIBLE thing for you to say. You have NO SCIENCE to back up such a statement. The reality is that bisphosphonates are WELL PROVEN with double blinded, randomly controlled studies to REDUCE FRACTURES in those at the most risk. If there appears to be a link here, then it should be thoroughly investigated with SCIENCE, as opposed to blanket statements by “doctors” with CLEAR CONFLICT OF INTEREST. Maybe there is a role for a drug holiday, maybe there are predisposing factors in these particular individuals such as drug-drug interactions. To impugn an entire class of medications with undeniable benefit to humanity: YOU ARE RECKLESS, BIASED, AND IRRESPONSIBLE. Your statement carries weight purely because of your “Dr” in front of your name. For god’s sake, your a freaking radiologist who went to a bio-identical hormone seminar, and suddenly became an “expert”: god bless america. You speak of the financial motives: oh yes, you clearly are above such influences. You are a hippocrate.

A few case reports does not make a study. If there appears to be a link, then it should be, and is being, investigated. However the fact remains that bisphosphonates are beneficial to humanity, especially those with osteoporosis and thus at tremendously high risk of both vertebral compression fractures and femur neck (hip) fractures.

Your statement is analogous to me saying bioidentical hormones such as estradiol causes fatal blood clots, strokes, heart attacks, and breast cancers and should be banned by the FDA. Though the side effects are real, they are relatively rare and the bad does not necessarily outweigh the good.

S.Lynch MD

PS: “Bio-identical” Estradiol is $4 per mth at Walmart: ask your “tainted” main-stream doctor for a prescription today and skip your trip to the “hollywood radiologist bio-identical specialist”.

Jeffrey Dach MD says: March 22, 2010 at 5:20 pm

Dear Dr Lynch,

Perhaps you should also be calling insanely irresponsible the 2010 AAOS meeting which presented studies from the Hospital for Special Surgery (HSS) and Columbia University Medical Center which showed that Fosamax disturbs bone formation, and implicated Fosamax in spontaneous mid-femur fractures.

Perhaps you should also be calling reckless, biased and irresponsible Clarita Odvina MD who reported nine cases of spontaneous femur fracture on Fosamax. Or Dr. Goh, a doctor in Singapore, who identified nine more cases in his 2007 report of subtrochanteric femur fractures with minimal trauma in women on long term Fosamax. Or Joseph M Lane MD who reported 15 cases of spontaneous femur fracture in women on Fosamax with a unique radiographic pattern.

Rather, I would say it is insanely irresponsible for any caring physician to give a drug that causes spontaneous mid femur fractures, jaw necrosis, and diffuse bone and joint pain.

You don’t need a double blind placebo controlled study to show a drug disturbs bone physiology. The histology slides don’t lie.

Conflict of interest? That is a laugh. Drug companies clean up on Fosamax,a 3 billion dollar industry. Now that kind of money can generate a real conflict of interest, documented by Aubrey Blumsohn MD who blew the whistle on the Actonel studies.

jeffrey dach md

steve livermore says: March 10, 2010 at 12:47 pm

My wife just went through this issue. Broken right femur just below the hib joint. The Hell she went through can not be described. Surgery…4 hours. Now therapy/rehab. She has stopped the fosamax after hearing the report given by Diane Sawyer and has an appointment with her regular doctor late this week. Being a vetern and in that system, she talked with her Vetern Doctor and that doctor knew nothing about the report. While on the phone she read the article on the computer and admitted that she, as a doctor, knew nothing of any issues until reading this. Log us in as one of many. We are praying for the ladies who will yet experience what my wife just went through.

Peter Stone says: March 9, 2010 at 3:40 pm

How’s this for a headline: FDA Fingers Fosamax For Femur Fractures!

Reply Carmen Berger says: April 26, 2010 at 9:04 am

I am replying for my wife – She has been taking fosomax for approx 7 years until
two years ago she broke her left femur by bending over during some work in
the home. Following recovery she discontinued taking the medication. The doctor
did not advise to the contrary. I would appreciate info on further developments in
this very important in this matter. Thanks.

02.02.10

Progesterone Prevents Aging in Men and Women

beautiful blonde womanBoth men and women produce progesterone throughout their lives. As we age, progesterone levels decrease significantly in both sexes.

A woman’s progesterone begins declining at age 35 and a man’s progesterone begins falling at age 45. The decline of progesterone is associated with mood disorders, anxiety and depression, poor sleep, osteoporosis, breast and uterine cancer, prostate cancer, as well as aging of the brain and nervous system.

To slow the aging process both men and women should test their progesterone levels regularly and take a natural progesterone supplement if their levels get too low. Progesterone is the natural counter balance to the harmful Estrogen known as Estradiol.

Excess Estradiol / Deficient Progesterone

Estradiol is the principal estrogen found in both men and women. A small amount is necessary for optimal function. However, too much Estradiol is associated with causing cancer of the breast, uterus and prostate.

Estradiol is fed to beef cows in the U.S. to make them put on more weight so that they can get them to market sooner and sell for more money. Estradiol is also concentrated in milk due to modern dairy farming techniques designed to boost milk production, including feeding cows hormones and milking pregnant cows until very late in their pregnancy.

Unfortunately, the trade-off we suffer is a higher rate of Estrogen induced disease, including cancer, which is not recognized or at least not admitted by the Dairy and Beef Industry.

Estrogenic Compounds in Plastics Linked to PMS and Cancer

Polyethylene terephthalate (PETE), the main ingredient in the plastic bottles most widely used for water, sodas, fruit juices, sports drinks, ketchup, mayonaise, peanut butter, vinegar and just about every other food you can think of, has been found to leach harmful estrogenic chemicals into the bottles’ contents. Known as phthalates, these chemicals have now been linked to the disruption of both male and female hormones and may be a significant reason for the dramatic increase in PMS, uterine fibroids, endometriosis and cancer.

To learn more about how PETE plastics may affect your health, click here.

Progesterone Deficiency in Women

In women, a deficiency of Progesterone and/or an excess of Estradiol is associated with PMS, uterine fibroids, endometriosis and Osteoporosis, as well as Breast, Ovarian and Uterine Cancer. Progesterone is the natural counter-balance to Estradiol. Progesterone activates Tumor Suppressor Protein (p53) to suppress excessive cell growth that can lead to cancer.

Progesterone and PMS

A deficiency of Progesterone and/or too much Estradiol causes excessive menstrual bleeding and cramping. It also causes PMS moodiness, bloating, acne, and breast tenderness. By raising your progesterone levels you can totally eliminate the symptoms PMS. Here’s how it works.

Progesterone and Mood/Sleep

Progesterone has a calming effect on the nervous system through its action on GABA, the calming neurohormone. Progesterone produces a valium-like effect on the stressed nervous system and creates a healthy EEG sleep pattern in the brain similar to that produced by valium.

Progesterone and Cancer

Progesterone increases the Tumor Suppressor Protein known as p53, the “guardian of the cell” and decreases the cancer activating protein known as bcl-2.

The Tumor Suppressor Protein p53 guards against cellular mutations that can cause cancer in the following ways:

  • Activation of DNA repair
  • Stops Cell growth when necessary to allow DNA time to repair
  • Initiates programmed cell death (apoptosis) when DNA damage is irreparable

Estradiol, on the other hand, does the opposite of progesterone. It causes a decrease in p53 and activates bcl-2, the opposite acting protein that promotes cancer cell growth.

Here’s the take home message: Breast cancer cells do not multiply when women have a sufficient supply of progesterone. Progesterone likewise also prevents cancer of the ovaries and uterus as well as the lungs.

Progesterone in Men

Men make about half as much progesterone as women. However, it is extremely important for men as well as it is for women. Progesterone gets converted into Testosterone. Most men know that the loss of Testosterone is associated with aging and causes decreased libido and erectile dysfunction. It is also associated with prostate cancer.

Progesterone preserves natural stores of Testosterone by preventing it from being converted into Di-Hydro-Testosterone (DHT), which blocks the prostate and causes Benign Prostate Enlargement and it’s bothersome symptoms including frequent urination, hesitancy, feeble urine stream and night-time urination. Too much DHT also blocks the hair follicles and is the principal cause of male pattern baldness.

A deficiency of Testosterone, in men or women, is associated with a loss of muscle mass, joint pains, heart disease and the tendency to put on excess abdominal fat. Taking supplemental natural progesterone can boost your Testosterone level.

Progesterone and Prostate Cancer

Men typically make a very small amount of Estrogen: about 1/10th the amount of a woman. If however, the ratio of Estrogen to Progesterone gets out of balance, prostate cancer develops for the same reason breast or uterine cancer develops in a woman. Progesterone protects against cancer growth and Estradiol activates cancer cell growth.

Progesterone Protects the Brain and Nervous System

Progesterone also protects and preserves the nervous system. Progesterone and Testosterone work together to prevent neurodegeneration of the central nervous system. Therefore, any age-related decline in progesterone may have a negative impact on brain, memory and nerve function. Additionally, progesterone and the natural, bio-identical estrogen known as Estriol, help reduce age-associated abnormalities of the myelin sheath that covers the nerves. New research indicates that supplementing these natural hormones could help prevent Multiple Sclerosis.

What is the best form and dose of Progesterone?

The most effective form of progesterone is the oral, sub-lingual form. Transdermal progesterone creams are less effective long term. The skin is designed to be a barrier, not to absorb hormones. It works well for a short while, but eventually progesterone applied to the skin gets shunted into fat cells and begins to build up. Eventually this excess progesterone can cause side-effects including moodiness and irritability.

The mucous membranes of the mouth however, were designed for absorption. When progesterone is absorbed in the mouth, it is absorbed and transported through the blood stream directly to the ovaries, uterus and receptors on the pituitary gland, before it is broken down in the stomach or the liver and excreted from the body. I have found this method to be very effective without any excess buildup over time.

The sublingual form is safe to take for extended periods. The usual sublingual dose is 50 to 100 mg of natural progesterone daily depending on the individual. To determine the correct amount that is right for you, I recommend saliva or blood testing before and after one to three months of natural progesterone therapy. Once the correct dose is found, you should make sure you get your progesterone level tested every twelve months to make sure your levels remain in the optimum range.

20.05.08

Female Hormone Test (Comprehensive) (Saliva)



Hormones Tested
Estrone
Estradiol
Estriol
Progesterone
DHEA
Testosterone

The Comprehensive Female Hormone Test is a safe, easy-to-use, noninvasive and reliable lab test that uses a simple saliva sample to measure your levels of Estrogen ( all three types: estradiol, estrone, estriol), Progesterone, Testosterone, and DHEA which are vital to a woman’s hormonal balance.

Reasons to take this test:
Menopausal and Perimenopausal Symptoms, Stress, Fatigue, Moodiness, Insomnia, Memory Weakness, Decreased Sexual Desire, Decreased Sexual Stimulation, Thinning and Loss of Pubic Hair, and Hormone Replacement Therapy (HRT) Monitoring.

Overview
Hormones exert a powerful influence over a woman’s health. Estrogens protect a woman from cardiovascular disease and osteoporosis and are vital for fertility. Progesterone levels affect mood, and balance the tissue proliferative effect of Estrogen. Testosterone increases energy, libido, and muscle.

A comprehensive assessment of your hormonal balance can be made by measuring Estrone, Estradiol, Estriol, DHEA, Progesterone, and Testosterone. Informed decisions regarding the need to initiate Bio-Identical Hormone Replacement Therapy (BHRT), or how to individualize therapy can then be made to maximize the health benefits of BHRT. Individual differences in hormone metabolism make monitored therapy the best choice for long term health.

Careful monitoring and individualization of BHRT can provide women with the benefits of supplemented natural Estrogen while reducing the risk of uterine, ovarian and breast cancer. (An increased cancer risk has been associated with conjugated Estrogen or synthetically modified hormone use. This is not the case with bio-identical or natural hormone use.)

Estrogen


A woman’s body produces three different Estrogens, in addition to DHEA, Progesterone and Testosterone which all start from cholesterol produced in the liver. Many women do not know that Testosterone is produced by both men and women. In fact, the steroid hormone Androstenedione is converted in both men and women to Testosterone first, then Testosterone is converted into Estradiol(E2), the major Estrogen secreted by the human ovary. The next most potent Estrogen is Estrone (E1), comes from Androstenedione. The third Estrogen, Estriol (E3), is synthesized outside the ovary in the peripheral tissues of the body from Estrone and Estradiol. It is known as the safe Estrogen.

Estriol has been shown to be protective against Breast Cancer. Low levels of Estriol place you at an increased risk for developing cancer. You should check all of your Estrogen levels annually to make sure that they are in a healthy balance approximately equal to a ratio of at least 8:1:1, Estriol to Estrone to Estradiol, respectively.

With advancing age, a woman’s ovarian function declines, leading to a decline in the production of Estrogen. This decline leads to vasomotor instability that causes hot flashes. It also causes decreased muscle mass, which is then replaced by fibrous tissue. Thinning skin is due to a loss of connective tissue support and elasticity. Vaginal mucous membranes also become thin and dry and breast tissue begins to sag. Supplementing natural Estriol (E3) can help stop many of these undesirable effects associated with menopause.

Progesterone
Progesterone is also produced by the ovaries from cholesterol. It has its own unique hormonal functions, but a certain amount is also converted into Estrogen. Progesterone increases uterine secretions and stimulates calcium deposits into bone tissue. It also helps regulate salt, control blood sugar, calms the nervous system and promote a healthy thymus gland. Supplementing natural Progesterone can help maintain these healthful benefits. You should have approximately ten times more Progesterone than Estriol for optimal balance.

Testosterone
When a woman’s ovarian function declines in the years before and during natural menopause, so does the amount of Testosterone she produces. Between a woman’s 20s and 40s the amount of Testosterone circulating in her blood declines about 50%. If a woman starts synthetic Estrogen Replacement Therapy at menopause, her blood levels of Testosterone drop even further due to a biochemical reaction.

Symptoms such as fatigue, muscle wasting, low sex drive, decreased sexual stimulation, and diminished sense of well-being can be due to a Testosterone deficiency. These symptoms may be significantly improved with natural Testosterone replacement.

DHEA
DHEA is the most abundant steroid in the body. DHEA is a steroid precursor produced by the adrenal gland and converted to Testosterone and the Estrogens. DHEA levels decrease dramatically with age. Adequate DHEA levels give the body the building blocks necessary to produce these hormones. Low levels of DHEA are associated with and increase in coronary artery disease, muscle wasting, abdominal fat and osteoporosis. Taking DHEA reverses these processes and may also increase the sense of well-being.

Hormone levels affect health and well-being.
Monitoring hormone therapy increases therapy benefits while reducing side effects.
Due to individual differences in hormone absorption and metabolism, the hormone dosage required to attain physiologic levels will vary by patient and method of administration.

References

  1. Samsioe G. The endometrium: effects of estrogen and estrogen-progestogen replacement therapy. Int J Fertil Menopausal Stud 1994;39 Suppl 2:84-92
  2. Davis S. Androgen replacement in women: a commentary. J Clin Endocrinol Metab 1999 Jun;84(6):1886-91
  3. Watts NB. Hulka BS. Epidemilogical analysis of breast and gynecological cancers. Prog Clin Biol Res. 1997;396:17-29.
  4. Rosano GM, Panina G. Cardiovascular pharmacology of hormone replacement therapy. Drugs Aging 1999 Sep;15(3):219-34
09.01.08

FDA WARNING: Osteoporosis Drug Side Effects

FDA Warns of Potential Side Effects of Bisphosphonate Use

Source: http://www.aafp.org/online/en/home/publications/news/news-now/clinical-care-research/20080109bisphosphonates.html

By News Staff 1/9/2008

Earlier this week, the FDA issued an alert highlighting the possibility of severe and sometimes incapacitating bone, joint and/or muscle pain in patients taking bisphosphonates. The agency is encouraging health care professionals to assess whether severe musculoskeletal pain in patients taking bisphosphonates, which are frequently prescribed to treat or prevent osteoporosis, could be attributed to their use of these drugs and to consider temporarily or permanently discontinuing their use.

The severe musculoskeletal pain that prompted the alert may occur within days, months, or years after starting a bisphosphonate and should not be confused with the acute phase response that sometimes accompanies initial administration of intravenous bisphosphonates and that also may occur with initial exposure to once-weekly or once-monthly doses of oral bisphosphonates, say FDA officials. The symptoms related to the acute phase response, which may include fever, chills, bone pain, myalgias and arthralgias, typically resolve within several days with continued drug use.

In contrast, the musculoskeletal pain symptoms described in the FDA alert may or may not resolve after discontinuing bisphosphonate use. Some patients have reported complete relief of symptoms after discontinuing the bisphosphonate, whereas others have reported slow or incomplete resolution.

The risk factors for and incidence of severe musculoskeletal pain associated with bisphosphonates are unknown.

Bisphosphonates decrease bone resorption by inhibiting osteoclast activity or through other mechanisms. Among the agents included in this class of drugs are alendronate sodium, marketed both as a generic and under the brand name Fosamax; ibandronate sodium, marketed as Boniva; and risedronate sodium, marketed as Actonel. Each of these drugs is indicated and widely prescribed for the treatment or prevention of osteoporosis in postmenopausal women.

Additional bisphosphonates currently approved for use in the United States are etidronate disodium, sold as Didronel; pamidronate disodium, sold as Aredia; tiludronate disodium, sold as Skelid; and zoledronic acid, sold (for different indications) under the brand names Reclast and Zometa.

Other indications for which agents in this class of drugs are used include:

  • treatment of glucocorticoid-induced osteoporosis in men and women,
  • treatment of Paget’s disease of bone in men and women,
  • prevention and treatment of heterotopic ossification associated with total hip replacement or spinal cord injury,
  • treatment of hypercalcemia of malignancy, and
  • management of patients with multiple myeloma and bone metastases from solid tumors.

Further background information, as well as additional recommendations and considerations for physicians and other health care providers, is available online from the FDA’s Center for Drug Evaluation and Research.

Adverse events associated with use of these or any other drugs should be reported to the FDA’s MedWatch program.