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Merck releases Phase III study data of oral treatment for osteoporosis

Merck has released the data of pivotal Phase III fracture outcomes study for odanacatib in postmenopausal women with osteoporosis.

Odanacatib, which is firm’s investigational once-weekly cathepsin K inhibitor, has reached the primary endpoints and significantly reduced the risk of osteoporotic hip, spine and non-vertebral fractures compared with placebo in the Long-Term Odanacatib Fracture Trial (LOFT), said Merck.

According to the company, treatment with odanacatib resulted in significant increase over five years in bone mineral density (BMD) at the lumbar spine and total hip.

Merck clinical research, diabetes and endocrinology vice-president Keith Kaufman said the company believes that the currently available data support a favorable benefit/risk profile for odanacatib.

"We want to thank our investigators who conducted the study and the thousands of patients who participated in this study, which is yielding critical insights into the potential of odanacatib in the treatment of postmenopausal osteoporosis," Kaufman added.

The company is planning additional analyses on the data of the trial, including an independent re-adjudication of major adverse cardiovascular events, in support of regulatory submissions.

LOFT is a randomized, double-blind, placebo-controlled and event-driven trial, which enrolled 16,713 women, aged 65 years or older, diagnosed with osteoporosis.