Wednesday, March 10, 2010

Stop Fosamax After Five Years

There has been a flurry of news about osteoporosis drugs in the media being dangerous. The class of drugs are called bisphosphonates and include medications like Fosamax (now available as generic alendronate), Actonel, and Boniva- the drug pitched by celebrity spokesperson Sally Field. These drugs are designed to treat osteoporosis which is a condition where the bones become brittle. Osteoporosis is common in older women because estrogen, which decreases after menopause, prevents bones from breaking down. In the past, hormone replacement was the primary treatment and preventative agent for osteoporosis, except the Women's Health Initiative study found hormone replacement to be associated with increase cancer and heart attack. Since that study, bisphosphonates have dramatically increased in use. In fact, there is good data to show that bisphosphonates not only strengthen bones, but can prevent fractures. Fractures of the spine and hip can be extremely debilitating.

However, reports from two recent studies surfaced and have created a media storm, and likely significant confusion for the millions of women that take these drugs. Today, the USA Today reported Long-term use of osteoporosis drugs linked to hip breaks and proud ABC boasted in its headlines: FDA to Investigate Possible Osteoporosis Drug-Femur Fracture Link After ABC News Report . This occurred after a Diane Sawyer story about a physician taking a bisphosphonat, who suffered a femoral fracture by doing nothing more than walking. The femur is the long bone in the leg. It is a strong bone, and rarely fractures, unless there is extreme trauma. Thus, it was surprising when reports surfaced of women similar to the doctor Ms. Sawer interviewed having sudden, non-traumatic fractures of their leg bones.

This is not the first we have heard of these reports. In today's FDA statement in response to the media attention (see FDA Drug Safety Communication: Ongoing safety review of oral bisphosphonates and atypical subtrochanteric femur fractures ) the FDA stated:

"Based on published case reports of atypical subtrochanteric femur fractures occurring in women with osteoporosis using bisphosphonates, FDA, in June 2008, requested information from all bisphosphonate drug manufacturers regarding this potential safety signal. All available case reports and clinical trial data were requested. FDA's review of these data did not show an increase in this risk in women using these medications."


In other words, the FDA knew about this, looked at the data, and didn't find a connection. Nonetheless, today's excitement is over two studies presented yesterday at the 2010 Annual Meeting of the American Academy of Orthopaedic Surgeons (AAOS). In one report (here is the link to the actual study ), researchers obtained bone biopsies from 21 postmenopausal women with femoral fractures; nine who did not take a bisphosphonate and twelve who did. They found some differences in the structure of the bone for the women who had taken a bisphosphonate. Of note, the average duration of bisphosphonate therapy in this study was 8.5 years. The second study was done at Columbia University, where researchers evaluated the bone structure of 111 postmenopausal women with primary osteoporosis, 61 of whom had been taking bisphosphonates for a minimum of four years and 50 controls taking calcium and vitamin D supplements. The study found that during the first four years, there was improvement in bone, but after 4 years, the trend started to reverse, and with longer treatment any gains made were diminished.

It is important to point out that femoral fractures are very rare, whereas osteoporotic fractures of the hip and spine are common, which is why bisphosphonate therapy is so important. However, even though the FDA's review in 2008 found no association, it appears there is a least a signal of a potential harmful type of fracture with the use of these drugs. Most importantly, these harmful effects appear to occur only in patients on long term use of these medications. The patient Diane Sawyer interviewed had been on Fosamax for over 10 years. The good news is that the beneficial effects of 5 years woth of taking a bisphosphonate are seen 5 years after stopping! In a study published in JAMA in 2006, Effects of Continuing or Stopping Alendronate After 5 Years of Treatment , patients who had been taking bisphosphonates for 5 years were randomized to taking 5 more years of a bisphosphonate or stopping. Though there were some decreases in bone structure in those patients that stopped the bisphosphonates, there were no differences in hip and spine fractures in the two groups. In other words, for patient taking bisphosphonates, it appears that after 5 years on the drug, at least a 5 year "holiday" should be taken.

Bottom Line: Osteoporotic fractures are a major source of disability for older women in the US. Bisphosphonates are an effective form of treatment for osteoporosis and can prevent fractures. Whether or not bisphosphonates can cause rare femoral fractures is unclear, but if they do, it appears to occur only after long term use. The real benefits of bisphosphonates are seen in the first 5 years of therapy, and experts are now recommending stopping bisphosphonates after 5 years, which should also diminish if not eliminate the risk for femoral fractures. If you are taking a bisphosphonate, don't stop.....unless you have taken it for 5 years or more, in which case you should discuss with your doctor about stopping the medication. (This goes for you too Sally).

16 comments:

Hypnosis Downloads said...

There are some differences in the structure of the bone for the women who had taken a bisphosphonate.

Ruthi said...

I was put on Fosomax 70 mg, 1-a-wk in Dec 2009. In Feb 2010 I developed headaches, sore arm and leg muscles. I stopped taking it March 21st. I'm still having a hard time getting around with the muscle pain. I read it stays in your system a long time, but after taking it for only 3 1/2 months, how long do I have to endure this pain?
Any information is appreciated.
Thanks, Ruthi

Phil said...

I'm a 61 year old man and have been taking Fosamax/Fosavance for 3 and a half years. Good bone density improvement after first year, less second year and even less improvement third year. I understand that the resistance to bone breakage is significantly reduced by this therapy irrespective of actual change in bone density therefore I would recommend it. I have no side effects but even if I did, I believe the potential consequences of osteoporosis need to be avoided at all costs.

Fosamax Lawyers said...

This is great advice. A new report has also indicated that intermittent use may be just as effective, and less destructive, than constant use, because it allows the bone remodeling to take place (they guess, anyway). Here's a link to an article we posted on the Fosamax research.

Disclosure: we are a law firm that is investigating the bisphosphonate manufacturers--not doctors--including the maker of Fosamax. While we welcome contacts from injured people so we can help them protect their rights, we also want the information out there, so feel free just to look at the info!

Fosamax Recall said...

Hi Doc. Can Fosamax be totally recalled because of the harmful side effects being mentioned? I'm recently blogging about this possibility and I'm looking for opinions of experts. Thanks.

Dr. Matthew Mintz said...

Fosamax recall,
While I agree there are some concerns about the drug, I don't yet think it's time to pull it from the shelves. Many of the patient you describe on your blog are reporting side effects that have not been attributed to Fosamax. Fosamax has been out for some time now. The new concern is femur fractures. Femur fractures seem to be a real, but very rare and serious side effect. So the issue is if 1000 women with osteoporosis take Fosamax, and hip fractures are prevented, but one femur fracture is caused, should we pull the drug from the market (not real numbers)? The answer is, it depends. It depends on alternatives. It depends on actual numbers. In my opinion, Fosamax is an important drug, but should be used (like every drug) carefully. For patients at high risks of hip fracture, the benefit likely outweighs the risk. As per the original post, I would not take for more than 5 years until more data comes out.

Jack said...

I took Fosamax in 2003. I had severe leg cramps. I switched to Boniva because I liked the once a month dose verses weekly.

doraoh said...

I am an very fit, active 62 year old woman, with poor bone density. I took alendronate for one year and bone density did not improve. Now my doc is urging me to try again and wait longer before eating (I was doing 30 min instead of 60). Here is my question: from what I can tell thru research on web, deadly hip fractures happen to women in their eighties. So, wouldn't it make more sense to wait until I'm older? Are there more studies on the long term benefits of taking the drug for 5 years? I've heard many different accounts about whether the improved bone density lasts after stopping the drug.

Dr. Matthew Mintz said...

doraoh,
Can't not give you specific information without knowing all the details (which is not appropriate for a blog). However..
1. All we know about long term Fosamax is that at 10 years, there doesn't seem to be any difference for taking Fosamax for 5 years or Fosamax for 10 years. Hopefully, further research will tell us what to do after 5 years on Fosamax followed by 5 years off.
2. Whether or not to take a medicine for osteoporosis/osteopenia is tricky. Yes, hip fractures happen later in life, but you want to treat the disease earlier to prevent them. The best thing to do is to use the FRAX model, which helps you calculate the real benefit. Here is the link:
http://www.shef.ac.uk/FRAX/tool.jsp

Anonymous said...

I have been taking Fosamax for the last 7 years the Doctor has said I should change to Denosumab injections. I do not like all the possible side effects and would like too take a break from taking any drugs. Am I making a mistake too stop? I am 74. Last year I broke a bone in my foot.

Dr. Matthew Mintz said...

I can not give specific medical advice online, especially without all the information.
If you have osteoporosis and have been on Fosamax, the doctor would hopefully be looking at DEXA scan numbers. If those numbers are going down despite Fosamax, this suggests another agent might be needed. Your age and your broken foot are also concerning for future, more serious fractures. I would recommend you discuss all your concerns with your doctor and ask him or her about all of your options and the risks and benefits of each option, including not taking anything. You can also see a specialist for a second opinion. In general, an endocrinologist specializes in osteoporosis,

Anonymous said...

why doesn't anyone look to a natural remedy vs. drugs. Resistance exercise ie walking, gardening and ultimately weight training reverse osteoporosis. to build strength your muscles and ligaments attach to the bone which is your foundation and resistance training makes your body increase its bone density to create a greater foundation. You do need a adequate diet to supply the necessary building blocks.

Dr. Matthew Mintz said...

I am all for diet and exericse, as it is so important for general health and disease prevention. Unfortunately, for disease treatment, diet and exercise doesn't do as well for many things (obesity and diabetes being the major exception). Specifically, for osteoporosis, the data does not support diet and exercise for treatment. In other words, if you are diagnosed with osteoporosis you are at significant risk for fracture. Weight bearing exercise and adequate calcium and vitamin D are an important part of treatment, but by themselves they are not effective. There was just a study released yesterday on high dose vitamin D, but this was a meta-analysis of several inconsistent studies. Thus, vitamin D may be an effective treatment. However, despite their side effects, bisphosphonates like Fosamax have proven to work. The good news is that 5 years seems to be as good as 10 years, with low risk of serious side effects.

Anonymous said...

I am a 61 year old woman who has been taking Fosamax for 10 years. I have mild osteoporis in the back and osteopenia in the hip. My last Dexascan in 2011 showed some mild improvement but I am concerned with continuing on Fosamax with the other fracture risks now surfacing. I am very active, walk 5 miles a day and do regular weight workouts. I am wrestling with the decision to stop. My OB/GYN is leaving it to me and we initially decided to wait until next year's Dexascan to see any further improvement, but I am worried now because of these other fracture risks. What would you suggest?

Dr. Matthew Mintz said...

@ anonymous 8/14,
I can not give specific medical advice on a blog. However, in general, if you have been on Fosamax for more than 10 years and your DEXA numbers are stable, considering stopping is a reasonable approach. For my patients who choose this route, I recommend a DEXA before stopping and a repeat DEXA one year after stopping to make sure that the numbers are stable.

Anonymous said...

I'm a 63 yr old womanm who was put on Fosamax in 2001. recen5le had been having some thigh pain when walking - did not know this was a warning signal. I took a tiny mis-step off a 3 inch step, fell, landed on my knee & snapped my femor right into - upper third of femur. while this was not a non-traumatic fracture, it did not seem to be of a severity to cause the injury. are there new studies that show the incidence of femur fx after long tern fosamax use? also, is there a place I should report thi?