NCT00529373

A Study of MK-0822 in Postmenopausal Women With Osteoporosis to Assess Fracture Risk (MK-0822-018)

A Phase III Randomized, Placebo-Controlled Clinical Trial to Assess the Safety and Efficacy of Odanacatib (MK-0822) to Reduce the Risk of Fracture in Osteoporotic Postmenopausal Women Treated With Vitamin D and Calcium

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 16,071 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: Female
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the event-driven base study is to determine the safety and efficacy, especially fracture risk reduction, of odanacatib in postmenopausal women diagnosed with osteoporosis. In a placebo-controlled extension of the base study, participants continued to receive the same blinded study medication for a total of up to 5 years of blinded study medication combined between the base study and the extension. After participants received 5 years of blinded study medication, they received open-label odanacatib through the end of the first extension. Participants were then invited to enroll in a second extension study in which they received open-label odanacatib for an additional 5 years. Two imaging substudies (PN032-Base/Extension and PN035) were conducted for participants in the MK-0822-018 Study. Additional safety information was collected for participants who discontinued from the base study or the blinded first extension in an observational follow-up study, MK-0822-083 (EudraCT number: 2007-002693-66) .

Conditions

• Postmenopausal Osteoporosis

Interventions

Type	Name	Description
DRUG	Odanacatib	50 mg tablet orally once weekly (OW)
DRUG	Placebo for Odanacatib	50 mg tablet orally OW
DIETARY_SUPPLEMENT	Vitamin D3	5600 IU orally OW
DIETARY_SUPPLEMENT	Calcium carbonate	If needed. Total daily calcium intake (from both dietary and supplemental sources) will be approximately 1200 mg but not to exceed 1600 mg

Timeline

• Start date: 2007-09-13
• Primary completion: 2012-11-14
• Completion: 2017-02-01
• First posted: 2007-09-14
• Last updated: 2024-06-11
• Results posted: 2019-11-14

Regulatory

• FDA-regulated drug study