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.
Conditions
Interventions
Pharmaceutical Form:
Sponsors
Laboratoires Merck Sharp & Dhome-Chibret
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: (1A) To evaluate the phenotypic distribution of aLBM, SPPB, and gait speed in the study population. Specifically to determine if, at baseline, measured traits (aLBM, SPPB and/or gait speed) form an appropriate distribution. (1B) To identify biomarkers of sarcopenia by evaluating low aLBM, low SPPB, and low gait speed, separately and in combination, by examining DNA and RNA in circulating blood. (2A) To determine if there is a measurable change in aLBM, SPPB, and gait speed over time within the duration of the study. Specifically to determine if the rate-of-change in the measured traits (aLBM, SPPB and/or gait speed) form an appropriate distribution. (2B) To identify biomarkers of rate-of-change (fast vs slow) of aLBM, SPPB, and gait speed, separately or in combination, by examining DNA and RNA in circulating blood. ; Secondary Objective: Exploratory Objectives: (1) To perform multiple and partial correlation analyses to estimate the relationship among the following variables: longitudinal changes in appendicular lean body mass, measured by total body DXA, longitudinal changes in the SPPB score, longitudinal changes in gait speed, and longitudinal changes in the chair stand test. (2) To estimate the relationship between baseline incident mobility-disability (defined as self-reported difficulty with either walking 400 meters or climbing 10 steps without resting) and baseline (a) aLBM; (b) SPPB score; (c) gait speed. (3) To estimate the relationship between incident mobility-disability in years 2-4 (defined as new-onset of self-reported difficulty with either walking 400 meters or climbing 10 steps without resting) and decline in (a) aLBM; (b) SPPB score; (c) gait speed from baseline to 1 year. ;Primary end point(s): Normalized clinical endpoint measurements, such as aLBM changes from baseline, will be dir | — |
Countries
France
Outcome results
None listed