A Phase III Randomized, Placebo-Controlled Study to Evaluate the Effect of Odanacatib (MK-0822) on Bone Mineral Density (BMD) and Overall Safety, and to Estimate the Effect of Odanacatib (MK-0822) on Bone Micro-architecture in Postmenopausal Women Treated with Vitamin D

• Conditions: low BMD (bone mineral density); MedDRA version: 9.1Level: LLTClassification code 10032364Term: Other osteoporosis

• Registration Number: EUCTR2008-004504-31-DK
• Lead Sponsor: Merck & Co., Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-08-28
• Last Update Posted: 15 May 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 196

Inclusion Criteria

1. Patient is 45-85 years of age on the day of Randomization.

2. Patient has been postmenopausal for at least 3 years, defined as no menses for at least 3 years OR at least 3 years status post bilateral oophorectomy.

3. Patient has a BMD t-Score at the total hip, hip trochanter, femoral neck or lumbar spine =–1.5 but >–3.5.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. The investigator believes that the patient is at sufficiently high risk for osteoporotic fracture within the next 24 months such that randomization to placebo would be unacceptable (e.g. patient has a BMD t-Score of <-3.5 AND history of low-dose glucocorticoid use).

2. Patient has had a previous hip fracture at any time.

3. Patient has experienced a non-hip clinical fragility fracture (including a clinical vertebral fracture) within 24 months. (Note: finger, toe and skull fractures are not considered with regard to this exclusion criterion)

4. Patient has had more than 1 prior clinical vertebral fracture and she is a suitable candidate for osteoporosis therapy. (i.e. bisphosphonates, strontium, or PTH).

5. Patient has chosen treatment with oral bisphosponates or other agents demonstrated to reduce the risk of hip fracture.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified