An Imaging Sub-Study of the Phase III Randomized, Placebo-Controlled Clinical Trial to Assess the Safety and Efficacy of Odanacatib (MK-0822) to Reduce the Risk of Fracture in Osteoporotic Postmenopausal Women Treated With Vitamin D and Calcium - The Imaging Sub-study for the Fracture Trial

Phase 1

• Conditions: Postmenopausal Osteoporosis; MedDRA version: 9.1Level: LLTClassification code 10017082Term: Fracture due to osteoporosis; MedDRA version: 9.1Level: LLTClassification code 10031285Term: Osteoporosis postmenopausal

• Registration Number: EUCTR2008-004578-42-DK
• Lead Sponsor: Merck & Co. Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09-19
• Last Update Posted: 2 October 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 400

Inclusion Criteria

1. Participant is already enrolled in Protocol 018.
2. Participant is willing to undergo all imaging procedures and bone biopsies.
3. Participant has two hips that are evaluable by DXA and QCT (e.g., contain no hardware from orthopedic procedures).
4. Participant has a spinal anatomy suitable for DXA and QCT of the lumbar spine. Significant scoliosis, bone deformity, and sequelae of orthopedic procedures that result in unsuitable anatomy must be absent from the lumbar spine. At least two vertebrae from L1-L4 must be evaluable.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
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. Participant has a history of tremors, Parkinson's disease, multiple sclerosis or other diseases that cause persistent tremors.
2. Participant is unable to take a bone-labeling agent (e.g., demeclocycline or tetracycline).
3. Participant has a past medical history of clotting or bleeding disorders.
4. Participant is unlikely to adhere to the study procedures or keep appointments, or is planning to relocate during the study.

Study & Design

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