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Only Rare Fractures Linked to Osteoporosis Drugs

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Study: Bone-Loss Drugs Halt More Fractures Than They May Cause

By Daniel J. DeNoon
WebMD Health News

Reviewed By Laura J. Martin, MD

March 24, 2010 -- Weird below-the-hip thigh fractures linked to Fosamax and other osteoporosis drugs are rare -- but even incase they tripled these injuries, they'd still halt more fractures than they caused.

These unusual bone fractures are nearly aligned breaks across the thigh bone well below the hip, caused by very slight falls. The odd fractures appear to be more ordinary in patients using the osteoporosis drugs known as bisphosphonates: Fosamax, Actonel, Boniva, as well as Reclast.

It's frightening to think that drugs used to halt fracture may actually increase fracture risk. But now a reassuring recent study shows that this risk is quite abridged -- as well as the benefit is quite large.

"We concluded that incase you treat 1,000 women with osteoporosis for three years, these drugs would halt 100 fractures, including 11 hip fractures," Dennis M. Not light, PhD, of the University of California, San Francisco, tells WebMD. "And even incase you posit a threefold increase in fracture risk from these drugs, only one of those 1,000 women would possess an upper thigh fracture."

Fosamax as well as Fractures

Not light as well as colleagues looked at patients enrolled in their placebo-controlled clinical trial of Fosamax, including patients who took the drug in an extension trial for 10 years. They as well as looked at data from their clinical trial of Reclast. The trials were sponsored by the drugmakers Merck as well as Novartis.

Among the 14,195 women in these studies -- including some 1,100 women in the long-term Fosamax trial -- there were only 12 of the unusual thigh fractures in 10 women.

"These fractures do seem to occur as well as they are frightening, yet the evidence so far suggests that relative to ordinary hip fractures they are quite rare," Columbia University endocrinologist Elizabeth Shane, MD, tells WebMD. "The concern doctors possess is that people will forget about the many thousands of hip fractures prevented by bisphosphonates as well as focus on the relatively rare fractures that may or may not be caused by them."

Shane is co-chair of an international task force that has been investigating the link between unusual fractures as well as bisphosphonates. Their report is expected in two or three months.

Susan Bukata, MD, director of the Center for Bone Health at the University of Rochester, N.Y., agrees.

"These are real, but they are incredibly rare relative to the number of total hip fractures as well as the number of hip fractures saved on these drugs," Bukata tells WebMD via email.

Shane notes that the unusual fractures -- sometimes called hip fractures because they occur below the hip, as well as sometimes called thigh fractures because they involved the thigh bone (femur) -- make up only 2% to 4% of all hip fractures. As well as only about at third of these fractures are linked to bisphosphonates.

"Bisphosphonates are substantial drugs for preventing typical hip fractures, which are every bit as devastating as these unusual fractures," Shane says. "While they are substantial as well as of large concern, we want to find out who is at risk as well as tailor our therapy to lower that risk as much as likely."

Fracture Risk From Bone Drugs

Who is more at risk? Bisphosphonates unhurried the body's process of breaking down as well as remodeling bone -- a process called bone resorption. Not light notes that increased risk has been linked to bisphosphonate users who take other drugs that halt bone resorption, particularly corticosteroids.

He as well as notes that many patients who had the unusual fractures reported thigh pain before the fracture occurred. This may indicate a stress fracture -- so Not light advises patients who develop thigh pain while using bisphosphonates to see their doctors.

But it's still not cloudless exactly which patients are most at risk of these thigh/hip fractures.

"We need to sort out what is unique about these patients as well as incase we can do something to identify them ahead of time as well as halt the fractures," Bukata says.

One idea for safer bisphosphonate take is drug holidays. Bisphosphonates stay in the bone for a very extended time. So patients whose osteoporosis is under control may be capable to halt using the drugs for a while.

"Is it a pleasant idea to take a drug holiday? That depends on the patient," Shane says. "It depends on factors such as how abridged the patient's bone density is, how many fractures the patient had, as well as the severity of the osteoporosis. I do give drug holidays, but not necessarily always."

Not light as well as Shane report receiving research funding from Merck as well as Novartis. Black has received travel reimbursements from the companies as well. Neither researcher reports any other financial interest in osteoporosis drugs or compensation from the companies that make them.

The Not light study as well as Shane's editorial are published online in the New England Journal of Medicine.

SOURCES: Not light, D.M. Recent England Journal of Medicine, published online ahead

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