MK 0822 meets primary endpoint in Phase III trial for Osteoporosis-Merck

Merck has announced data from the pivotal Phase III fracture outcomes study for MK 0822 (odanacatib) in postmenopausal women with Osteoporosis. In the Long-Term Odanacatib Fracture Trial (LOFT), odanacatib met its primary endpoints and significantly reduced the risk of osteoporotic hip, spine and non-vertebral fractures compared with placebo. Compared to patients on placebo, patients who received odanacatib had a 54% relative risk reduction of new and worsening morphometric vertebral fractures, a 47% relative risk reduction of clinical hip fractures, a 23% relative risk reduction of clinical non-vertebral fractures and 72% relative risk reduction of clinical vertebral fractures. The rates of adverse events overall in LOFT were generally balanced between patients taking odanacatib and placebo.

In addition, treatment with odanacatib led to progressive increases over five years in bone mineral density (BMD) at the lumbar spine and total hip. Adjudicated events of morphea-like skin lesions and atypical femoral fractures occurred more often in the odanacatib group than in the placebo group. Adjudicated major adverse cardiovascular events were generally balanced overall between the treatment groups. The results from this trial were presented at the American Society for Bone and Mineral Research Annual Meeting.