Osteoporosis Drugs: New Calculator Tells Are They Worth the Risk?

Osteoporosis is a major, worsening public health problem, and bisphosphonates which help restore a healthier balance of bone production and resorption, have been a relatively inexpensive, successful treatment, particularly for those at the highest risk for fractures. But even as the population ages, the drugs’ use has been trending down amid patient concerns about rare, but potentially serious side effects linking their long-term use to unusual fractures of the femur or thigh bone, the biggest bone in the body, and an even more rare jawbone loss called osteonecrosis.

How to calculate the risk/benefit ratio of osteoporosis drugs?

Investigators have launched a five-year study funded by the National Institutes of Health to analyze big, diverse datasets of males and females who have been using these drugs to objectively assess the risk and benefits of continuing to take bisphosphonates versus taking so-called drug holidays, which can stretch out for years, to avoid the rare side effects.

Their bottom line will be developing a risk calculator called CLUB (calculator for the length of use of bisphosphonates) that a physician can use to help an individual patient determine how best to proceed.

Right now, they are having these discussions all the time, even as the risk associated with drug holidays remains uncertain with emerging reports of women sustaining osteoporotic fractures during these holidays.

Osteoporosis is the major cause of fractures in the hip and vertebra in the spine and wrist — most often in white and Asian postmenopausal women and older men, according to the National Institute of Arthritis and Musculoskeletal and Skin Diseases. A broken bone may be the first clear indicator of the problem.

However, even the small possibility that the drugs you are taking to strengthen bone could lead to fractures and bone loss is tough to digest, she adds, and impossible to ignore.

Bisphosphonates were first approved by the Food and Drug Administration in 1995 to help keep bone strong, but the FDA and other professional groups have since developed guidelines suggesting that after three years of taking the intravenous version and five years of taking the oral version.

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The new study will first examine relevant data on about a half million females and males from diverse races and ethnicities who live both independently and in long-term care facilities available from Kaiser Permanente, HealthPartners, and the Veterans Health Administration.

Benefits and Risks of Bisphosphonate Therapy For Osteoporosis

Researchers will use the data they find to address those identified gaps, including looking specifically at those with so-called comorbid conditions, which are concurrent health problems like diabetes and high blood pressure in addition to their osteoporosis, as well as the impact of fractures.

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They are looking at details like how long patients took the drugs, if they took drug holidays and if they experienced any fractures, and what type.

CLUB should provide that sort of objective risk assessment for those already taking the drug. Based on the data we will be analyzing; the expert panel is going to decide whether you should benefit from a drug holiday based on your risk of an atypical femoral fracture versus your risk of an osteoporotic fracture.

Atypical breaks in the femur are tied to long-term use of bisphosphonates and are considered atypical because they relate more to the fragility of the usually strong bone as opposed to more typical breaks that might happen.

While the association between jawbone problems and long-term use of bisphosphonates is not as clear as with atypical femur fractures, the experts will also be looking closely at the relationship based on their data to see if there is objective cause for concern.

While exercise is good for our overall health and does help build bone when you are younger, with age it helps more with avoiding falls and strengthening the muscle to support bone.



Source-Eurekalert