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)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Osteoporosis

Treatments: Drug: Calcium supplement; Drug: Odanacatib; Drug: Placebo; Drug: Vitamin D3

Study type: Interventional

Funder types: Industry

Identifiers

NCT00729183

2008_539 (Other Identifier)

0822-031

Details and patient eligibility

About

This study will evaluate the safety and treatment effect of 50 mg odanacatib (MK-0822) with Vitamin D versus placebo with Vitamin D in postmenopausal women with low bone density. The primary efficacy hypothesis is that odanacatib will increase aBMD at the lumbar spine compared to placebo at 12 months.

Enrollment: 214 patients

Sex: Female

Ages: 45 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participant has been postmenopausal for 3 years
• Participant has BMD t-score at the total hip, hip trochanter, femoral neck, or lumbar spine ≥ -1.5 but > -3.5
• Participant has 2 hips that are evaluable by dual-energy X-ray absorptiometry (DXA) and quantitative computed tomography (QCT), e.g. contain no hardware from orthopedic procedures
• Participant is ambulatory

Exclusion criteria

• Participant has had a previous hip fracture
• Participant has had >1 prior clinical vertebral fracture AND is a candidate for osteoporosis therapy
• Participant has been treated with oral bisphosphonates, strontium, parathyroid hormone (PTH) or other agents with an effect on bone
• Participant has had metabolic bone disorder other than osteoporosis
• Participant has renal stones, Parkinson's disease, multiple sclerosis (MS) or active parathyroid disease.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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214 participants in 2 patient groups, including a placebo group

Odanacatib 50 mg

Experimental group

Description:

Participants receive 50 mg odanacatib and open-label 5600 IU vitamin D3 tablets once weekly for 24 months. Participants also receive 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg.

Treatment:

Drug: Odanacatib

Drug: Vitamin D3

Drug: Calcium supplement

Placebo

Placebo Comparator group

Description:

Participants receive matching placebo to odanacatib and open-label 5600 IU vitamin D3 once weekly for 24 months. Participants also receive 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg.

Treatment:

Drug: Placebo

Drug: Vitamin D3

Drug: Calcium supplement