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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 2

Conditions: Osteoporosis

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00885170

CTRI/2009/091/000218 (Registry Identifier)

2009_578 (Other Identifier)

2008-008257-30 (EudraCT Number)

0822-042

Details and patient eligibility

About

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.

Enrollment: 246 patients

Sex: Female

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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246 participants in 2 patient groups, including a placebo group

Odanacatib 50 mg

Experimental group

Description:

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.

Treatment:

Drug: Odanacatib

Dietary Supplement: Calcium

Dietary Supplement: Vitamin D3

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo

Dietary Supplement: Calcium

Dietary Supplement: Vitamin D3