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Investigational drug reduced bone resorption markers, increased BMD
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Postmenopausal women assigned to an investigational cathepsin-K inhibitor called odanacatib experienced reductions in bone resorption markers and progressive increases in bone mineral density during 4 years of treatment.
Treatment with odanacatib 50 mg weekly (Merck) for 4 years was associated with an increase in BMD of 2.8% at the lumbar and 2.7% at the hip between years 3 and 4 of treatment. During 4 years of treatment, women in the odanacatib arm had increases in lumbar spine (10.7%) and hip (8.3%) BMD from baseline.
Levels of serum CTx (–41% from baseline) remained low, whereas BSAP (–2% from baseline) remained relatively unchanged between years 3 and 4 of the study.
In women who received odanacatib for 2 years during the base study but were switched to placebo for the 2-year extension (n=38), the effects on bone turnover markers and BMD were reversed, returning to, or near, baseline.
The most frequently reported adverse events during the 4-year extension included nasopharyngitis (13% vs. 17%) and pain in the extremities (10% vs. 2.4%) compared with placebo.
Odanacatib is currently in phase 3 clinical trials and is being evaluated in a large-scale clinical study to determine the potential effects on vertebral, non-vertebral and hip fractures.
For more information:
- Binkley N. Concurrent oral session 42: Osteoporosis treatment – pharmacologic and nonpharmacologic. #1247. Presented at: American Society of Bone and Mineral Research 2010 Annual Meeting; Oct. 15-19, 2010; Toronto.
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