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)

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

214 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-02

Study Completion Date

2011-03-21

Brief Summary

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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.

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Detailed Description

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Conditions

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Osteoporosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Odanacatib 50 mg

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.

Group Type EXPERIMENTAL

Odanacatib

Intervention Type DRUG

Odanacatib 50 mg tablets, taken orally once weekly for 24 months.

Vitamin D3

Intervention Type DRUG

Vitamin D3 tablets (5600 IU) taken orally once weekly for 24 months.

Calcium supplement

Intervention Type DRUG

Calcium supplement 500 mg tablet taken orally once daily (up to \~1200 mg total) for 24 months.

Placebo

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Matching placebo tablets to odanacatib taken orally once weekly for 24 months.

Vitamin D3

Intervention Type DRUG

Vitamin D3 tablets (5600 IU) taken orally once weekly for 24 months.

Calcium supplement

Intervention Type DRUG

Calcium supplement 500 mg tablet taken orally once daily (up to \~1200 mg total) for 24 months.

Interventions

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Odanacatib

Odanacatib 50 mg tablets, taken orally once weekly for 24 months.

Intervention Type DRUG

Placebo

Matching placebo tablets to odanacatib taken orally once weekly for 24 months.

Intervention Type DRUG

Vitamin D3

Vitamin D3 tablets (5600 IU) taken orally once weekly for 24 months.

Intervention Type DRUG

Calcium supplement

Calcium supplement 500 mg tablet taken orally once daily (up to \~1200 mg total) for 24 months.

Intervention Type DRUG

Other Intervention Names

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MK-0822 calcium carbonate calcium citrate

Eligibility Criteria

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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.

Minimum Eligible Age

45 Years

Maximum Eligible Age

85 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No