Features November 2016 Issue

Osteoporosis Drugs: Benefits Outweigh Risks

Fear of rare side effects is raising risk for bone fractures.

Many people who would benefit from osteoporosis drugs are missing out on the possibility of preventing bone fractures, including of the hip and spine, which are most associated with decline in functioning and even death. More than half of older adults who sustain a hip fracture end up in a nursing home, and up to 20 percent die within one year.

Drugs to protect bones in women and men with the bone-thinning disease osteoporosis have been available since 1995. Yet use of bisphosphonates, the most commonly prescribed ones, declined by 50 percent between 2008 and 2012, according to a study published in the Journal of Bone and Mineral Research (December 2015). About half of people who start these drugs are no longer taking them one year later. This is true even for people who’ve already broken a hip.

Reluctance to Take Drugs

healthy bone graphic

ゥ Peterjunaidy | Dreamstime.com

Healthy bone

osteoporotic bone graphic

ゥ Peterjunaidy | Dreamstime.com

Osteoporotic bone

“Osteoporosis doesn’t have any symptoms until a fracture occurs, so people don’t feel any better when they take their medicine,” says Chad Deal, MD, Head of the Center for Osteoporosis and Metabolic Bone Disease at Cleveland Clinic, and Associate Editor of Arthritis Advisor. About 10 percent of people have heartburn or other stomach problems and stop the drugs. Fear of rare but distressing side effects, like deteriorating jawbones and thigh bone (femur) fractures, may be driving much of the reluctance to take osteoporosis drugs.

These side effects should be kept in perspective. The risk for breaking a femur (called an atypical fracture) increases with prolonged use of a bisphosphonate. These fractures almost never occur in the first three years of treatment. Only one in 1,000 people who take the drugs have an atypical fracture after eight years of treatment. A recent study published in the journal BMJ (June 2016) found the risk was probably lower. Jawbone problems are even rarer, occurring in less than one in 50,000 people who take the drugs.

Minimizing Side Effects

While uncommon, these problems are serious and physicians take measures to avoid them. Jawbone deterioration is more likely to occur in people with dental issues. “Before giving these medications, we take a dental history and ask people to undergo any needed oral surgery that requires cutting bone,” says Dr. Deal.

Because atypical fractures occur only with prolonged use, it is standard to consider a drug holiday, depending on the risk for fracture. “We initially thought these drugs had to be taken consistently for life,” says Dr. Deal. “Now we know that bisphosphonates bind to bone and remain there, sometimes for years.”

After three to five years of taking one of the oral bisphosphonate medications (Fosamaxョ, Actonelョ, Bonivaョ), fracture risk will be assessed. If it is low to moderate, the drug may be stopped for two years. If the risk is high, the drug will likely be continued for up to 10 years. For the intravenous bisphosphonate (Reclastョ), three to six years of therapy is recommended.

Fracture risk is assessed with the FRAXョ model, which takes into account bone density and factors such as age, gender, smoking, previous fracture and presence of rheumatoid arthritis (which increases risk forosteoporosis).

The rare side effects are associated with all of the bisphosphonates and the drug denosumab (Proliaョ). These drugs work by slowing down the breakdown of bone. The osteoporosis drugs teriparatide (Forteoョ) and raloxifene (Evistaョ) work by a different mechanism and don’t carry a risk for jaw problems or atypical femurfractures.

“The potential to prevent a hip or spine fracture with osteoporosis drugs is a thousand times greater than the risk of a rare side effect," says Dr. Deal. Gastrointestinal side effects are rarely serious and can be dealt with by switching to a different drug.

Comments (8)

On June 21, 2015 I broke my femur when I tripped in my playroom. At the ER I was told that according to the x-rays, both my femurs were splinted due to havinf Reclast infusions for 5 years. The following day I had a rod placed in my right femur. On July 24, 2015 I spontaneously broke my left femur and had a rod placed in that femur. Since then I have had many complications including c.diff , vaginitis and auto immune problems. It has been 22 montgs and my right leg still has pain. Before June 21, 2015, I was a healthy, active woman who was substitute teaching almost every day, doing yoga, tap dancing, doing belly dancing, gardening and cleaning and repairing things in my home. Now I am limited by the pain.
My mother took Fosamax for years and Reclast for 2 years. She subsequently broke both his spontaneously in 2013 and 2014. She is now 96 andcan bearly walk.
No other women in my family in the last two generations broke any bones and lived into their 80s and 90s.
This tells me that these bisphosphonates need to be taken off the market. They are poison to those who take them. I don't want any other person to suffer as I have.
Sincerely, Sharon Herman

Posted by: Sharon Herman | April 23, 2017 3:24 PM    Report this comment

I had a femur/Fosamax fracture in 2002. I took Fosamax in good faith, which was a major mistake. I was standing in my kitchen when my leg suddenly collapsed. Apparently, it was broken before I hit the floor.
I wish I had been aware of the risks associated with bisphosphonates. My well-known orthopedic surgeon told me I was his first femur/Fosamax. He currently sees patients all the time who have suffered from this type of fracture.
I regard asking patients to take a drug holiday as absurd. Since there is no way of knowing which patients will be harmed by these drugs, why take them at all?

Posted by: diana klebanow | November 19, 2016 5:32 PM    Report this comment

I'm another of those "rare" victims of atypical femur fractures caused by long-time use of Fosamax for osteopenia. My doctor first prescribed it in 2001 because I was post-menopausal and my Dexa score was a little low. In 2008, after several weeks of pain do to a stress fracture, my left femur fractured when I tripped and tried to regain my balance. I ended up with a metal rod inserted in the bone, with screws at my knee and hip. My right femur broke in 2011, so now I have a matching set of rods, screws and scars for both legs. My right femur didn't break or heal as neatly as the left, so I have one leg 1" shorter than the other, which affects my walking and standing. Since I am supposedly 1 out of 1000 people according to the statistics you quoted, I wonder how many of those 999 other people who haven't broken a leg actually took their Fosamax faithfully once a week as prescribed, and did the advised weight-bearing exercise as regularly as I did? I have a feeling that a little more in-depth research would show that there aren't that many who did. Show me people who have taken the drug properly for 5 or more years, been physically active and put stress on their legs, but haven't had fractures and I'll start to believe those statistics. And then I'll advise them all to get bone scans ASAP if they ever start to feel pain in their legs because "sure as shootin'" they'll be headed for a fracture.

Posted by: kklossner | November 19, 2016 3:23 PM    Report this comment

In 2000 I was automatically prescribed Fosamax by a young male doctor because I was, as he put it, "a woman of a certain age". No tests were done at the time, and later ones showed neither osteoporosis nor osteopenia. In 2010 as I was walking up two steps at church when my left femur broke under me. I DIDN'T FALL. My leg simply collapsed. A competent doctor rodded my leg. Immediately, I began researching why this would have happened because I'd done nothing to cause the break - except take the Fosamax. Fortunately, he began to listen to me and when I experienced pain in my right femur four months later, he recommended prophylactic rodding which I underwent. Fosamax and similar drugs have been carelessly prescribed, without testing for osteoporosis or osteopenia, from the minute they appeared on the market. I can imagine scions in the drug companies rubbing their hands and cackling with glee over the vast market of unsuspecting women to whom their unlearned physicians were now going to prescribe these "preventatives"....and the billions of dollars they would rake in. Don't tell me about "rare".

Posted by: nanslinger | November 19, 2016 6:54 AM    Report this comment

I took Reclast for 5 years to strengthen my bones. Seventeen months ago I tripped and broke my right femur. At the hospital I was told that both femurs were compromised because of Reclast. After surgery and 3 weeks in rehab, I broke my left femur spontaneously. I had many complications after and am still not completely better. My mother who is 96, took Fosamax for years and was injected with Reclast for 2 years. Subsequently, she had 2 hip fractures two years apart and now can hardly walk.
Nothing is worth going through the pain and agony I have experienced . No one should take bisphosphonates. The drug companies just want money. I was a very healthy 67 year old woman and am now continue to suffer. If any doctor perscrbes bisphosphonates, just say no. Please!

Posted by: Sharon Herman | November 18, 2016 6:58 PM    Report this comment

Two months ago, I stood up, took a step, and my left femur shattered! I had taken Actonel for 10 years! The trauma surgeon who inserted a rod to hold my leg together knew immediately what had caused the fracture! I spent 10 days in the hospital receiving blood and dealing with complications! Then more days in a rehab center ! X-rays showed my right leg was about to fracture! I recently underwent surgery to add a rod and metal plate to my right femur. And I'm currently in rehab , in a great deal of pain , and do not see any relief! All of this was caused by Actonel! I, like many others, have suffered permanent pain and damage from this so called 'helpful' medication! V.White

Posted by: VWhite | November 18, 2016 6:02 PM    Report this comment

I agree with dianmerr above, I was given Fosamax in 1997 because a DEXA scan sowed I had Osteopenia. I was told I would be on it for life to prevent Osteoporosis. In March 2009 I was standing in my back yard, I felt my leg give and I went crashing to the ground. I broke my right femur. A rod and screws were put in my right femur from the knee up.As a result I have nerve damage in my right leg as well as pain in the knee. In November 2009 we found out I had a stress fracture in the left femur. That on was rodded with a locking hip nail. I still walk with a cane for balance and up & down curbs etc.
There have been research articles in the past few years that it is more like 1 in 500 people who will have a femur fracture. In Sept 2009 my Dexa scan showed I didn't even have Osteopenia. All of my Dexa scans have been normal. Dexa scans show quinaty not quality.

Posted by: njpons | November 18, 2016 6:00 PM    Report this comment

The FDA warnings didn't become known until 2010, so perhaps that is why usage has dropped during that time period. Also, bisphosphonates were widely marketed and prescribed as a preventative for people who did not have osteoporosis, as was the case for me. The warnings made it clear that it was not to be used in this way, but it was too late. After 5 years of use as a preventative following a diagnosis of osteopenia, I got up from my kitchen table and my right femur snapped like a toothpick. It would be interesting to study the atypical fracture statistics separating those who took these drugs to treat osteoporosis from those who took it as a preventative, which I don't think this article does; it seems to lump them all together. i suspect these fractures are not so rare as claimed. The current data leaves many unanswered questions. There is not yet enough information available to assure me that these drugs can be safely used for any period of time.

Posted by: dianmerr | November 18, 2016 3:15 PM    Report this comment

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