None listed
Conditions
Interventions
Group 1 Type of group
50 mg odanacatib (MK-0822) once a day
Group name:Group 2 Type of group
50 mg placebo of odanacatib (MK-0822) once daily
Sponsors
MERCK SHARP & DOHME PERU S.R.L.,
Eligibility
Sex/Gender
Female
Age
65 Years to 99 Years
Inclusion criteria
Inclusion criteria: • The patient is randomized and actively participates (in treatment) in Protocol 018. If the patient is discontinued from Protocol 018, then she can no longer participate in this substudy. • The patient is willing to participate in the substudy as indicated by signing in the informed consent form for this substudy. The consent form for this substudy includes general consent and consent for genetic testing and RNA.
Exclusion criteria
Exclusion criteria: • Active conditions that limit general physical strength and function, particularly musculoskeletal conditions in the lower extremities, such as: Rheumatoid arthritis, polymyalgia rheumatica, polymyositis, Cushing´s syndrome, Neuromuscular diseases (ie, stroke, multiple sclerosis), Major surgery in the lower extremities in the last 2 months • The patient has congestive heart failure of Class III or IV established by the New York Heart Association (NYHA),
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:The longitudinal study with the SPPB scores (N ~ 2000) will be carried out with mixed effects models, where genotypes will be the independent variable and the SPPB scores will be the dependent variable to be predicted. For the GS analysis, real time measurement will be used and not the individual score! of the GS from the SPPB. The longitudinal study with the aLBM (N 2000) will be carried out with mixed effects models, where the genotypes will be the independent variable and the SPPB scores will be the dependent variable to be predicted. Measure:Verification of whether at baseline the measured characteristics (aLBM, SPPB and / or gait speed) form an appropriate distribution. Timepoints:During the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:The longitudinal study with the SPPB scores (N ~ 2000) will be carried out with mixed effects models, where genotypes will be the independent variable and the SPPB scores will be the dependent variable to be predicted. For the GS analysis, real time measurement will be used and not the individual score! of the GS from the SPPB. The longitudinal study with the aLBM (N 2000) will be carried out with mixed effects models, where the genotypes will be the independent variable and the SPPB scores will be the dependent variable to be predicted. Measure:Variation in the biomarkers of sarcopenia evaluating a low aLBM, a low SPPB, and a low gait velocity, separately and in combination, examining the DNA and RNA in circulating blood. Timepoints:During the study ; Outcome name:The longitudinal study with the SPPB scores (N ~ 2000) will be carried out with mixed effects models, where genotypes will be the independent variable and the SPPB scores will be the dependent variable to be predicted. For the GS analysis, real time measurement will be used and not the individual score! of the GS from the SPPB. The longitudinal study with the aLBM (N 2000) will be carried out with mixed effects models, where the genotypes will be the independent variable and the SPPB scores will be the dependent variable to be predicted. Measure:Identification of a quantifiable change in the aLBM, the SPPB and the speed of gait over time within the duration of the study. Timepoints:During the study | — |
Contacts
Public ContactStela Lopez
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed