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

aboratoires Merck Sharp & Dhome-Chibret0 sites2,000 target enrollmentMarch 19, 2009

Overview

Phase: Phase 1
Intervention: Not specified
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.
Sponsor: aboratoires Merck Sharp & Dhome-Chibret
Enrollment: 2000
Status: Active, not recruiting
Last Updated: 6 years ago

No summary available.

Registry

who.int

Start Date

March 19, 2009

End Date

October 18, 2012

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Sponsor

aboratoires Merck Sharp & Dhome-Chibret

•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

•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