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

Merck Sharp & Dohme (MSD)

Status and phase: Terminated; Phase 3

Conditions: Postmenopausal Osteoporosis

Treatments: Drug: Placebo for Odanacatib; Dietary Supplement: Vitamin D3; Dietary Supplement: Calcium carbonate; Drug: Odanacatib

Study type: Interventional

Funder types: Industry

Identifiers

NCT00529373

0822-018

2007_610

132238 (Registry Identifier)

2007-002693-66 (EudraCT Number)

Details and patient eligibility

About

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) .

Enrollment: 16,071 patients

Sex: Female

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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16,071 participants in 2 patient groups, including a placebo group

Odanacatib

Experimental group

Description:

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.

Treatment:

Drug: Odanacatib

Dietary Supplement: Calcium carbonate

Dietary Supplement: Vitamin D3

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Dietary Supplement: Calcium carbonate

Dietary Supplement: Vitamin D3

Drug: Placebo for Odanacatib