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Cathepsin-K inhibitor improved BMD over 5 years
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ASBMR 2011
Odanacatib, an investigational cathepsin-K inhibitor, was associated with continued increases in bone mineral density at the spine and hip and reductions in bone resorption markers among postmenopausal women with low bone mineral density, according to 5-year study data.
Researchers conducted a 2-year, phase 2b study of 141 postmenopausal women with BMD T-scores between -2 and -3.5 at the lumbar spine, femoral neck, trochanter or total hip. The study was extended by 3 years to examine the efficacy and long-term safety of odanacatib (Merck) in this patient population.
According to a press release, the primary endpoint was BMD at the lumbar spine. Secondary endpoints included BMD at the femoral neck, trochanter, hip and distal radius; levels of bone resorption markers, including urine collagen type I cross-linked N-telopeptide (NTx)/creatinine, levels of bone formation markers, including serum bone-specific alkaline phosphatase (BSAP); and safety assessments.
Thirteen patients received weekly odanacatib 50 mg continuously for 5 years. Among these patients, BMD increased by 11.9% at the lumbar spine, 9.8% at the femoral neck, 10.9% at the hip trochanter and 8.5% at the total hip. Additionally, these women had a 67.4% lower level of urine NTx/creatinine through year 5, and levels of serum BSAP remained only slightly reduced relative to baseline (-15.3%). Fourteen women were switched from treatment to placebo after the 2-year base study; among these, BMD returned to near baseline levels.
Groups were pooled for comparison on the incidence of adverse events in the placebo and odanacatib arms due to the small sample size in each individual treatment group (10 mg, 25 mg or 50 mg). Forty-one of the 114 women treated with 10 mg, 25 mg or 50 mg weekly dose of odanacatib at any time during the first 3 years of the study were treated with placebo, and 73 with odanacatib 50 mg during years 4 and 5 of the study, according to the press release. Adverse events occurred in 81% of the placebo group and 89% of the treatment group.
Two women assigned to odanacatib discontinued treatment due to adverse events. Skin-related adverse events occurred in 17% of the placebo and 12% of the treatment group.
For more information:
- Binkley N. Plenary poster session. Abstract #FR0453. Presented at: the American Society for Bone and Mineral Research 2011 Annual Meeting; Sept. 16-20, 2011; San Diego.
Disclosure: Dr. Binkley has received research grants from Merck.
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