-- All men and women with diagnosed osteoporosis or a history of fragility fractures should be offered pharmacologic treatment, the American College of Physicians has recommended in a new clinical guideline.
Clinicians should also consider prescribing medication for men and women who have an increased risk of osteoporosis, Amir Qaseem, M.D., Ph.D., of the ACP, and guideline co-authors recommended in the Sept. 16 issue of Annals of Internal Medicine.
Selection of a specific drug for treatment should be based on a risk-benefit assessment of each patient, the authors said.
"Bisphosphonates are a reasonable option because they reduce the risk of vertebral, nonvertebral, and hip fractures," Dr. Qaseem said in an interview. "However, the evidence was insufficient to show the superiority of one bisphosphonate over the others, since there was a lack of head to head trials."
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The guidelines reflect an emphasis on the quality of supporting evidence. The ACP Clinical Efficacy Assessment Subcommittee made recommendations only when they could be supported by high-quality evidence, said Dr. Qaseem.
Clinical consensus and expert opinion were considered inadequate as a basis for any recommendation.
The committee found "good-quality evidence" of fracture prevention from placebo-controlled trials of several types of drugs. For vertebral fractures, those drugs included alendronate (Fosamax), etidronate (Didronel), risedronate (Actonel), ibandronate (Boniva), calcitonin, teriparatide (Forteo), raloxifene (Evista), and estrogen. For nonvertebral and hip fractures, drugs with good evidence were alendronate, risedronate, and estrogen.
Evidence for calcium alone is uncertain, and studies of calcium and vitamin D have produced conflicting evidence, the committee concluded.
The appropriate duration of bisphosphonate therapy was unclear, as clinical trials ranged from three to 60 months.
Evidence of efficacy in special populations varied:
Review of data on adverse effects of pharmacologic therapies showed that oral bisphosphonates are associated with gastrointestinal side effects, the authors wrote. However, pooled analyses showed no differences versus placebo for alendronate, ibandronate, risedronate, or zoledronic acid.
Pooled analyses of etidronate studies suggested an increased risk of mild gastrointestinal events compared with placebo.
The report also noted that "case reports and case series have documented increased osteonecrosis of the jaw in patients receiving bisphosphonates, but that most cases of osteonecrosis have occurred in patients with cancer who received high doses of intravenous bisphosphonates."
Evidence linking zoledronic acid to atrial fibrillation was contradictory.
In a pooled analysis, raloxifene increased the risk of pulmonary embolism and thromboembolic events and estrogen was associated with an increased risk of cererbrovascular and thromboembolic events.
Because most trials of other pharmacologic therapy included their use, the guideline authors recommended adding calcium and vitamin D to osteoporosis treatment regimens.
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Additional source: Annals of Internal Medicine Source reference: Qaseem A, et al "Pharmacologic treatment of low bone density or osteoporosis to prevent fractures: a clinical practice guideline from the American College of Physicians" Ann Intern Med 2008; 149: 404-415. |