A Study to Evaluate the Safety, Tolerability, and Efficacy of Odanacatib (MK-0822) in Postmenopausal Women Previously Treated With a Bisphosphonate (MK-0822-042)

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

246 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-13

Study Completion Date

2011-09-15

Brief Summary

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The study will evaluate the both the efficacy of odanacatib on Bone Mineral Density (BMD) and the safety of odanacatib for postmenopausal osteoporosis in patients previously treated with alendronate. The primary hypothesis of the trial is that treatment with odanacatib 50 mg once weekly will increase bone mineral density at the femoral neck compared to placebo at the end of 24 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

Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of 1200 mg.

Group Type EXPERIMENTAL

Odanacatib

Intervention Type DRUG

Odanacatib 50 mg tablets once weekly for 24 months

Vitamin D3

Intervention Type DIETARY_SUPPLEMENT

Vitamin D3, two 2800 IU tablets, taken once weekly for 24 months

Calcium

Intervention Type DIETARY_SUPPLEMENT

Participants will receive calcium carbonate supplements as needed to ensure a daily calcium intake of 1200 mg.

Placebo

Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of 1200 mg.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo to odanacatib 50 mg tablets once weekly for 24 months

Vitamin D3

Intervention Type DIETARY_SUPPLEMENT

Vitamin D3, two 2800 IU tablets, taken once weekly for 24 months

Calcium

Intervention Type DIETARY_SUPPLEMENT

Participants will receive calcium carbonate supplements as needed to ensure a daily calcium intake of 1200 mg.

Interventions

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Odanacatib

Odanacatib 50 mg tablets once weekly for 24 months

Intervention Type DRUG

Placebo

Placebo to odanacatib 50 mg tablets once weekly for 24 months

Intervention Type DRUG

Vitamin D3

Vitamin D3, two 2800 IU tablets, taken once weekly for 24 months

Intervention Type DIETARY_SUPPLEMENT

Calcium

Participants will receive calcium carbonate supplements as needed to ensure a daily calcium intake of 1200 mg.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Has been postmenopausal for at least 5 years
* Has taken or is taking alendronate
* Agrees not to use medications for osteoporosis other than what is provided by the study

Exclusion Criteria

* Has a history or evidence of hip fracture
* Has a history of cancer within 5 years of screening, except certain skin or cervical cancers.
* Has active parathyroid disease
* Has a history of thyroid disease not adequately controlled by medication
* Is taking anti-seizure medication and has abnormal calcium metabolism
* Has received any bisphosphonate other than alendronate for 20% of the last 3 years, or within 3 months of screening

Minimum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No