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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

16071 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-13

Study Completion Date

2017-02-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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) .

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study to Examine the Effects of an Experimental Drug on Postmenopausal Osteoporosis (MK-0822-004)

NCT00112437

Osteoporosis

COMPLETED PHASE2

Study to Evaluate Efficacy of Odanacatib (MK-0822) on Bone Mineral Density (BMD) and Bone Micro-architecture and Overall Safety in Postmenopausal Women (MK-0822-031)

NCT00729183

Osteoporosis

COMPLETED PHASE3

Efficacy and Safety of Odanacatib (MK-0822) in Participants With Involutional Osteoporosis (MK-0822-022)

NCT00620113

Osteoporosis Postmenopausal

COMPLETED PHASE2

A Study to Assess Safety and Efficacy of Odanacatib (MK-0822) in Men With Osteoporosis (MK-0822-053)

NCT01120600

Osteoporosis

COMPLETED PHASE3

Efficacy and Safety of Odanacatib in Postmenopausal Women Previously Treated With Alendronate (MK-0822-050)

NCT01552122

Osteoporosis Postmenopausal Osteoporosis

WITHDRAWN PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Postmenopausal Osteoporosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Odanacatib

Participants receive 50 mg of blinded odanacatib weekly over the course of the base study and first extension study (5 years total), followed by 50 mg of open-label odanacatib weekly for 5 years. Participants also receive Vitamin D3 and open-label supplemental calcium so that total daily calcium intake (from both dietary and supplemental sources) is approximately 1200 mg.

Group Type EXPERIMENTAL

Odanacatib

Intervention Type DRUG

50 mg tablet orally once weekly (OW)

Vitamin D3

Intervention Type DIETARY_SUPPLEMENT

5600 IU orally OW

Calcium carbonate

Intervention Type DIETARY_SUPPLEMENT

If needed. Total daily calcium intake (from both dietary and supplemental sources) will be approximately 1200 mg but not to exceed 1600 mg

Placebo

Participants receive blinded placebo to 50 mg of odanacatib weekly over the course of the base study and first extension study (5 years total), followed by 50 mg of open-label odanacatib weekly for 5 years. Participants also receive Vitamin D3 and open-label supplemental calcium so that total daily calcium intake (from both dietary and supplemental sources) is approximately 1200 mg.

Group Type PLACEBO_COMPARATOR

Placebo for Odanacatib

Intervention Type DRUG

50 mg tablet orally OW

Vitamin D3

Intervention Type DIETARY_SUPPLEMENT

5600 IU orally OW

Calcium carbonate

Intervention Type DIETARY_SUPPLEMENT

If needed. Total daily calcium intake (from both dietary and supplemental sources) will be approximately 1200 mg but not to exceed 1600 mg

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Odanacatib

50 mg tablet orally once weekly (OW)

Intervention Type DRUG

Placebo for Odanacatib

50 mg tablet orally OW

Intervention Type DRUG

Vitamin D3

5600 IU orally OW

Intervention Type 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

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

MK-0822 Calcium supplements

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Postmenopausal women (for at least 5 years) who are ≥65 years of age and have low bone mineral density
* Ambulatory (able to walk)

Exclusion Criteria

* Must not be taking osteoporosis therapy or have a metabolic bone disorder other than osteoporosis
* Has or has had a hip fracture
* Currently participating in another drug study

Minimum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No