Alendronate May Not Be Cost-Effective in Postmenopausal Women With Osteopenia

Laurie Barclay, MD

May 05, 2005

May 5, 2005 — Alendronate should not be used to treat postmenopausal women with osteopenia and who are otherwise not at high risk for fracture, according to the results of a cost-effectiveness analysis published in the May 3 issue of the Annals of Internal Medicine.

"Treatment guidelines recommend drug treatment to prevent fractures for some postmenopausal women who have low bone mass (osteopenia) but do not have osteoporosis or a history of clinical fractures," write John T. Schousboe, MD, MS, from the University of Minnesota in Minneapolis, and colleagues. "As public health policy, however, such intervention makes sense only if the costs and risks of treatment are outweighed by a reduction in the ultimate cost and disability attributable to osteoporotic fractures."

To estimate the societal costs and health benefits of alendronate treatment to prevent fractures in postmenopausal women with osteopenia, the authors used a Markov model with eight health states: no fracture, postdistal forearm fracture, postclinical vertebral fracture, postradiographic (but clinically silent) vertebral fracture, posthip fracture, posthip and vertebral fractures, post-other fracture, and death.

The target population was postmenopausal women 55 to 75 years of age with femoral neck T-scores between -1.5 and -2.4. Data were obtained from population-based studies of age-specific fracture rates and costs, prospectively measured estimates of disutility after fractures, and the Fracture Intervention Trial comparing five years of alendronate therapy with placebo for fracture prevention. Primary outcomes were costs, quality-adjusted life-years, and incremental cost-effectiveness ratios.

Depending on age and femoral neck bone density, the cost per quality-adjusted life-year gained for women with no additional fracture risk factors ranged from $70,000 to $332,000. Based on sensitivity analyses, the authors concluded that these results were sensitive to changes in fracture risk reduction attributable to alendronate and alendronate cost.

Study limitations include lack of generalizability beyond postmenopausal white women living in the U.S., possible overestimation of the true cost-effectiveness of antiresorptive therapy in postmenopausal women because of slight overestimation of the incidence of vertebral fractures, failure to include indirect costs from loss of ability to do housework or care for other family members, assumption of zero long-term care costs attributable to nonhip fractures, failure to model changes in bone mineral density from alendronate therapy, and failure to consider risk factors that are not measured routinely in clinical practice.

"Alendronate therapy for postmenopausal women with femoral neck T-scores better than -2.5 and no history of clinical fractures or other bone mineral density-independent risk factors for fracture is not cost-effective, assuming U.S. costs of alendronate and currently available estimates of alendronate efficacy in osteopenic women," the authors write. "This conclusion should be reconsidered, however, if the cost of drug therapy is significantly lowered, if drug therapy is shown to reduce the risk for nonvertebral fractures in this population, or if fracture reduction benefit persists longer than 10 years after a five-year treatment course."

Two of the authors report potential financial conflicts of interest with Hologic, Inc., Eli Lilly & Co., and/or Pfizer.

In an accompanying editorial, Michael R. McClung, MD, from the Providence Portland Medical Center in Oregon, notes several caveats with this study.

"Bone density measurement remains an important tool in assessing skeletal health, but the determinants of fracture are much more complex and interesting than simply the T-score," Dr. McClung writes. "The objective of using osteoporosis drugs is to prevent fractures. This can be accomplished only by treating patients who are likely to have a fracture, not by simply treating T-scores."

Dr. McClung reports potential financial conflicts of interest with Eli Lilly & Co., Merck & Co., Procter & Gamble, Sanofi-Aventis, and Roche.

Ann Intern Med. 2005;142:734-741, 796-797

Reviewed by Gary D. Vogin, MD

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