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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Osteoporosis

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01120600

0822-053

2010_532 (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to test the hypothesis that treatment with odanacatib will result in increased bone mineral density (BMD) compared to treatment with placebo. This study will also evaluate the safety and efficacy of odanacatib for male osteoporosis participants.

Full description

The original study was divided into two parts, with the primary analysis of endpoints to occur at 24 months and participants will then remain in the study for an additional 12 months (Part 2). Amendment 1 of the protocol removed the additional 12 month period and the Month 36 BMD analysis was deleted.

Enrollment: 294 patients

Sex: Male

Ages: 40 to 95 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Is a male between 40 and 95 years of age
• Has osteoporosis
• Has anatomy suitable for dual energy x-ray absorptiometry (DXA) scan of the lumbar spine and and hip
• Is ambulatory

Exclusion criteria

• Is currently on oral bisphosphonates or other treatment for osteoporosis
• Had previous hip fragility fracture and is a candidate for standard of care therapy
• Has had a fragility fracture (vertebral or non-vertebral fractures indicating reduced bone strength) within 12 months
• Has had more then one previous vertebral fracture
• Has been diagnosed with metabolic bone disorder other than osteoporosis
• Is Vitamin D deficient
• Has a history of renal stones
• Has active parathyroid disease
• Has history of thyroid disease not well controlled by medication
• Is diagnosed with secondary osteoporosis
• Has a daily calcium intake of <1,200 mg and is unwilling to take study prescribed supplements or increase dietary intake, such that his daily calcium intake is at least 1200 mg
• Has a history of malignancy ≤5 years prior to signing informed consent
• Has been diagnosed with hypogonadism due to causes that affect multiple organ and body systems

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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294 participants in 2 patient groups, including a placebo group

Odanacatib 50 mg once weekly

Experimental group

Description:

Participants will receive one Odanacatib 50 mg tablet once weekly. In addition, they will receive a weekly dose 5600 IU of open-label Vitamin D3 as well as a sufficient supply of open-label calcium carbonate so that their 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 once weekly

Placebo Comparator group

Description:

Participants will receive one Placebo tablet once weekly. In addition, they will receive a weekly dose 5600 IU of open-label Vitamin D3 as well as a sufficient supply of open-label calcium carbonate so that their total daily calcium intake from both dietary and supplemental sources is approximately 1200 mg.

Treatment:

Drug: Placebo for Odanacatib

Dietary Supplement: Calcium carbonate

Dietary Supplement: Vitamin D3