1. Home>
2. Specialties>
3. Women's Health>
4. Summary and Comment

A New Approach to Treating Osteoporosis?

Denosumab injections every 3 or 6 months increased BMD among these postmenopausal women.

Given the high prevalence of osteoporosis and the personal and financial burden caused by frailty fractures, new approaches to treating this condition have considerable appeal. Denosumab is a humanized monoclonal antibody to the receptor activator of nuclear factor-B ligand (RANKL). RANKL is expressed by osteoblastic stromal cells and mediates bone resorption. By binding RANKL with high affinity, denosumab reduces bone resorption.

In this manufacturer-sponsored, multicenter study, researchers examined the efficacy and safety of denosumab among 412 postmenopausal women (mean age, 63; 85% white) who had low BMDs (T-score, –1.8). The women were randomized to receive denosumab (at 1 of 3 doses given subcutaneously every 3 or 6 months), the bisphosphonate alendronate (70 mg orally once weekly), or placebo; 369 participants completed 1 year of treatment.

In intent-to-treat analyses at 1 year, mean lumbar spine BMD had increased by 3.0% to 6.7% with the various denosumab dosages and by 4.6% with alendronate, and had decreased by 0.8% with placebo (differences between active treatment and placebo were significant). Serum and urine markers of bone turnover indicated that bone resorption was suppressed within 3 days of denosumab injections; the duration of suppression was dose-dependent. Denosumab appeared to be well tolerated. Dyspepsia occurred more often with alendronate than with denosumab or placebo.

Comment: Although hormone and bisphosphonate therapy effectively prevent osteoporotic fractures in postmenopausal women, many patients fail to adhere to such treatment. The results of this important trial provide support for ongoing development of denosumab, an innovative agent that appears to rapidly inhibit bone resorption and increase BMD with subcutaneous injections every 3 or 6 months.

— Andrew M. Kaunitz, MD

Published in Journal Watch Women's Health April 4, 2006

Citation(s):

McClung MR et al. Denosumab in postmenopausal women with low bone mineral density. N Engl J Med 2006 Feb 23; 354:821-31.

• Original article (Subscription may be required)
• Medline abstract (Free)