A Quantitative Computed Tomography (QCT) 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

Phase 1

• Conditions: postmenopausal osteoporosis

• Registration Number: EUCTR2009-011920-69-NO
• Lead Sponsor: Merck & Co., Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2009-04-10
• Study Start: 2009-05-06
• Last Update Posted: 19 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 1800

Inclusion Criteria

1. Participant is already enrolled in Protocol 018.
2. Participant is willing to undergo all QCT imaging procedures.
3. Participant's Body Mass Index (BMI) is = 35 kg/m2
4. Participant has a spinal anatomy that is suitable for QCT of the lumbar spine from T12 through L3 (e.g. does not have significant scoliosis, bone deformity, hardware or sequelae of orthopedic procedures. Note: Surgical clips are acceptable.)
5. Participant has two hips that are evaluable by QCT (e.g., contain no hardware from orthopedic procedures). Note: Surgical clips are acceptable.

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, or other movement disorder that may interfere with imaging by QCT.
2. Participant has any metallic hardware in the abdomen or pelvis, such as orthopedic implants, that may interfere with imaging of the hip or spine by QCT.
3. 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

Primary Outcome Measures

Name	Time	Method
Primary end point(s): Trabecular Volumetric Bone Mineral Density (vBMD), Trabecular Volume, Cortical vBMD and Cortical Volume of the lumbar spine and hip.;Main Objective: 1. To explore the relationship between baseline bone strength at the lumbar spine, estimated from QCT-based finite element analysis, and the risk of vertebral fractures.<br>2. To explore the relationship between baseline bone strength at the hip, estimated from QCT-based finite element analysis, and the risk of non-vertebral (including hip) fractures.<br>;Secondary Objective: 1. To explore the relationship between changes in bone strength at the lumbar spine, estimated from QCT-based finite element analysis, and the risk of vertebral fractures.<br>2. To explore the relationship between changes in bone strength at the hip, estimated from QCT-based finite element analysis, and the risk of non-vertebral fractures (including hip).<br>