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

Last updated: May 20, 2024
Sponsor: Merck Sharp & Dohme LLC
Overall Status: Terminated

Phase

3

Condition

Post-menopausal Osteopenia

Osteoporosis

Treatment

Placebo for Odanacatib

Calcium carbonate

Odanacatib

Clinical Study ID

NCT00529373
0822-018
2007_610
2007-002693-66
132238
  • Ages > 65
  • Female

Study 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) .

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Postmenopausal women (for at least 5 years) who are ≥65 years of age and have lowbone mineral density

  • Ambulatory (able to walk)

Exclusion

Exclusion Criteria:

  • Must not be taking osteoporosis therapy or have a metabolic bone disorder other thanosteoporosis

  • Has or has had a hip fracture

  • Currently participating in another drug study

Study Design

Total Participants: 16071
Treatment Group(s): 4
Primary Treatment: Placebo for Odanacatib
Phase: 3
Study Start date:
September 13, 2007
Estimated Completion Date:
February 01, 2017