A Substudy to Explore Biomarkers of Physical Function in 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 - Sarcopenia Sub-Study

Phase 1

• Conditions: This is an exploratory sub-study of Protocol 018 (Eudract N°2007-002693-66) to identify biomarkers of physical function. This biomarker sub-study will use an ongoing clinical study (Protocol 018) for osteoporosis as a starting point for identification of molecular biomarkers in circulating blood for patient identification and sarcopenia progression. Patients recruited in Protocol 018 are women 65 years of age or older with osteoporosis and either 0 or 1 prior vertebral fracture.; MedDRA version: 9.1 Level: LLT Classification code 10031283 Term: Osteoporosis fracture; MedDRA version: 9.1 Level: LLT Classification code 10031285 Term: Osteoporosis postmenopausal

• Registration Number: EUCTR2008-005874-11-FR
• Lead Sponsor: aboratoires Merck Sharp & Dhome-Chibret

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-03-19
• Study Completion: 2012-10-18
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 2000

Inclusion Criteria

1. Patient is randomized and actively participating (on treatment) in Protocol 018. If the patient is discontinued from Protocol 018 then she can no longer participate in this sub-study.

2. Patient is willing to participate in the sub-study as indicated by signing the informed consent form for this sub-study. The consent form for this sub-study includes general consent and consent for genetics and RNA testing.
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. Active conditions that limit general physical strength and function, particularly musculoskeletal in the lower extremities, such as:

• Rheumatoid arthritis, polymyalgia rheumatica, polymyositis, Cushing’s syndrome
• Neuromuscular diseases (i.e. stroke, multiple sclerosis)
• Major surgery in the lower extremities in the past 2 months

2. Patient has New York Heart Association (NYHA) Class III or IV congestive heart failure

Study & Design

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