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: 9.1 Level: LLT Classification code 10017082 Term: Fracture due to osteoporosis; MedDRA version: 9.1 Level: LLT Classification code 10031285 Term: Osteoporosis postmenopausal

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-10-21
• Study Completion: 2014-11-11
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 164

Inclusion Criteria

1. Participant is already enrolled in Protocol 018.
2.Participant is willing to undergo all QCT and DXA imaging procedures and biomarker assessments.
3. Participant's body habitus allows for QCT scanning (i.e. Body Mass Index (BMI) is = 35 kg/m2).
4.Participant has two hips that are evaluable by DXA and QCT (e.g., contain no hardware from orthopedic procedures). Note: Surgical clips are acceptable.5.Participant has a spinal anatomy suitable for DXA and QCT of the lumbar spine. (e.g. does not have significant scoliosis, bone deformity, hardware or sequelae of orthopedic procedures. Note: Surgical clips are acceptable.) For DXA, at least 2 vertebrae from L1-L4 must be evaluable and for QCT, at least 2 vertebrae from T12-L3 must be evaluable.
6. Participant understands the study procedures and the risks involved with the study and voluntarily agrees to participate by giving written informed consent.

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 unlikely to adhere to the study procedures or keep appointments, or is planning to relocate during the study.
3. Participant baseline QCT imaging scan, of the hip or spine, is of insufficient quality, as confirmed by the central imaging vendor.

Study & Design

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