3/11/10 Two new studies presented at the 2010 conference of American Academy of Orthopaedic Surgeons (AAOS) are highlighting health concerns with long-term use of bisphosphonate medications, which are used to treat the bone loss caused by osteoporosis.
The studies suggest that when the medications are taken for longer than four years, the drugs, which are designed to strengthen bones, may actually make them weaker, leading to an increased risk of fractures in the femur, the long bone of the thigh.
In response to the studies, the Food and Drug Administration (FDA) has stated that it is conducting an ongoing review of the safety of this class of medications, which includes the popular drugs alendronate sodium (Fosamax), ibandronate sodium (Boniva), risedronate sodium (Actonel) and zolendronic acid (Reclast), to see if the increased risk of femur fractures outweighs the proven benefits.
Read the FDA’s full safety communication here.
And people like Jennifer P. Schneider, MD, PhD, a doctor of internal medicine in Tuscon, Ariz., say they feel validated by the results of the new studies.
In 2001, Dr. Schneider was riding the subway while visiting New York City when one wrong step changed her life.
“The train jolted. I stepped hard on that leg and it buckled. The femur broke, and I fell,” she says.
At the age of 57, Dr. Schneider was hospitalized for weeks, needed two surgeries and had to use a walker for a year-and-a-half.
It was years before she learned the bizarre fracture caused in a low-impact situation could have been related to the long-term affects of the prescription medication alendronate sodium (Fosamax) that she had been taking for about seven years to treat osteoporosis.
“I had pain in my thigh for several months before that, and back then, nobody even suspected it was connected to Fosamax, and the doctor didn’t think anything was wrong with my leg. But I was walking around with an undiagnosed stress fracture of the femur,” she says.
On March 1, 2010, the FDA approved a change to the patient labeling for Fosamax that informs people taking the drug about the risk of low-energy femoral fractures.
Merck, the company that makes Fosamax, says it updated the labeling to reflect the experiences reported by patients, not to “reflect a conclusion that post-marketing event is caused by the product,” says Ron Rogers, a company spokesman.
“Just because a post-marketing event has been reported doesn't mean there's a causal relationship. In fact at this point, no causal relationship has been established between bisphosphonates and low femural fractures,” Rogers says.
He continues, “In clinical studies, which are the gold standard for assessing the benefits and risks of medications, Fosamax has not been associated with an increased fracture risk at any skeletal site. “
New research sheds light on rise in rare fracture
Bisphosphonates are a type of drug designed to prevent and treat osteoporosis by building bone and stopping calcium loss.
Many previous studies have shown that short-term use of these medications is very successful early on at stopping the outflow or destruction of bone and preventing fractures of the hip and spine.
But with long-term use of these medications, doctors have been seeing a growing number of patients suffering from a rare type of thigh fracture as a result of little or low trauma. Such trauma can happen from stepping off a curb too hard, for example, or from a relatively minor fall.
My BM improved greatly and the doctor told me that we will discuss the pro and con of stopping the med.
I will have to make a decision
I would appreaciate some help in making this decision.
Thank you
My ortho guy is saying the left femur healing is delayed and considering rodding the right femur and putting in a bigger rod in the left femur. He has advised using crutches until he sees me after a month-and a-half to see if any changes have occurred.
If no positive changes have occurred, should I proceed with the additional rodding or are there other alternatives? All my dotors are advising increased dosages of Vitamin D and Calcium and blood is tested regularly for Vit. D levels.
Vitamin D doesn't cure every problem but it is important to start by correcting any vitamin D deficiency (costs about 6 cents per day)before subjecting yourself the unknown side effects and questionable benefits, if any, of the currently used drugs.
I am tired of drug companies using us for their Guinea pigs!!
I want to know what test will help people like us determine if we are at risk for fracture? Will a regular bone densitometry test do the job, or do I need a biopsy?
I've had both hips replaced and the implant rods extend down into my thigh bone. Does this protect my femurs from fracture, or up the risk?
My most recent physical showed I haven't lost any height due to vertebral micro fractures. Is this good news or not related?
Reports like these are frustrating - they never give you enough information.
Over the past 2 years, I have done considerable research on the internet about the long term use of bisphosphonates. A few points that I find quite interesting and disturbing are below:
- Bisphosphonates were tested 2 to 3 years max, then they were put on the market for millions of women (and men). The long term effects were obviously unknown.
- It is known through studies, that Bisphosphonates in the short term (a couple of years) do strenghen bone which I think is good for people with incurable bone cancer as they generally don't live long.
- In the long term studies, they are finding that bisphosphonate make the bone brittle and hard. We are hearing about more and more cases of fractures, as well as osteonecrosis ONJ, etc..
- Animal studies have also shown vertebral dammage as well.
- When looking at images (CT & MRI) on the net, it is interesting to note that Bisphonsphonate-damaged bone images and cancer-damaged bone images look the same. Hence the possibility for a misdiagnosis as cancer, as in my case.
- The way that bisphosphonates "work" is disturbing, as it is a completely unnatural process. How can it be a positive thing to change the natural way that the bone works.
- Bisphosphonates stay in the body for years after you cease taking them. Do they stop having adverse effects on the bone as soon as you stop taking them, or not?
- Doctors (GPs), who obviously don't have time to research every drug on the market, are unaware of the recent concerns about bisphosphonates, and so they continue to prescribe them freely.
I have been off Actonel now for about 9 months. I changed my calcium from "carbonate" to "citrate" (which absorbs better), and added more vitamin D. I just had a bone density done and there has been no change. I will not go back on bisphosphonates, as I believe that it is likely that they caused the damage to my vertebrae.
Do you know if there is a way to determine if this damage is a result of long term use of a bisphosphonate?? Do you know who I could contact in the medical/research field?
In February of this year, 2010, again on a trip, my left ankle and leg began to hurt. I immediately went to a drug store and purchased a brace for the left ankle. (I was still wearing a brace on the right ankle.) When I got home my orthopedist diagnosed another fracture--this time the left ankle. He is trying a prescription of ZyfloCr 600mg 2 tablets twice daily. My endocrinologist had advised me to stop Fosamox, which I did after the first fracture in April of 2009.
So now I am in an ankle brace on the right ankle (It has not yet healed after 11 months.) and a boot on the left ankle for a new fracture and am using a cane to help me get around. I now use the bone stimulator 6 hours a day! I had a second opinion also. Every doctor just shrugs his shoulders and tells me to be patient. I could have surgery to put a plate and screws in each ankle but so far I have resisted until someone can tell me what is going on.
I am going "loopy" and would like some answers or at least suggestions as to what direction to go. PLEASE HELP!
I have had 2 hip replacements and 2 back surgeries. I am 45 years old.
I believe Forteo to be the best product on the market. It has done a lot for me.
Thank you.
She has had multiple emergency surgeries, where she almost and should have died. Her esophagus was eaten through from Fosamax. Her internal organs actually shifted, etc...
Prior to all this happening, she had complained to her doctor that the commercial on TV mentioned that if you had problems with your esophagus that you shouldn't take it. He simply said, "Well, don't take it!"
These osteoporosis drugs also make your teeth so hard that dentists have a hard time even drilling on them. (My nephew is a dentist).
I just read the article from the American Academy of Orthopedic Surgeons on bisphosphonates such as Actonel and fractures. I have been taking Actonel for over 8 years and have just had my right leg femur break for no reason. Please advise.
Thank you
SueAnn Ramsaroop
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