Sarcopenia MedDRA version: 8.0 Level: LLT Classification code 10063024
Conditions
Interventions
Product Name: MK-0677
Pharmaceutical Form: Tablet
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-
Pharmaceutical form of the placebo: Tablet
Route of administra
Sponsors
Merck Sharp & Dohme (Sweden) AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Patient is 3 to 15 days postoperative repair of a unilateral hip fracture that is considered partially or fully weight bearing after the surgery •Patient is judged to have been able to ambulate independently at home prior to their hip fracture (able to walk indoors in a familiar setting with little or no aid from another person) based on a score of 0 (none) or 1 (a little) on the first question of the “Pre-Fracture Ambulation Independence” Questionnaire. Patients who score a 2 (a lot) or a 3 (unable) on this question at Visit 1 are NOT eligible for entry into this study. •Prior to starting the study medication, the patient is enrolled in a rehabilitation program (as an in-patient or as an out-patient), planned to provide a minimum of 10 hours of physical therapy over a 2 to 4 week period. The patient must be enrolled in, but does not have to start the rehabilitation program prior to randomization. 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: •Patient has Type I diabetes. •Patient has Type II diabetes with any of the following conditions: (1)Patient has a HbA1C >7.5% during screening, (2)Patient is currently taking more than one anti-hyperglycemic agent, (3)Patient is currently receiving insulin, (4)Patient has diabetic retinopathy, (5)Patient is unwilling or unable to monitor glucose at home •Patient has been diagnosed with any neuromuscular or neurological disease causing muscle weakness. •Patient has cancer, or had a diagnosis of any malignancy within the last 5 years, except for adequately treated basal cell or squamous cell skin cancer, or adequately treated in situ cervical cancer. •Patient was living in a nursing home prior to the hip fracture. (Note: Patients living in an assisted living facility prior to the hip fracture are eligible for enrollment). •Patient was permanently wheelchair bound prior to the hip fracture •Patient has a hip fracture that is due to bone pathology other than osteoporosis (e.g., malignancy, or Paget’s Disease), or major trauma (e.g. motor vehicle accident).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: In patients who have recently experienced a hip fracture, to demonstrate an improvement in overall physical functional performance (as measured by the Continuous Scale Physical Functional Performance 10-item Test [henceforth abbreviated as PFP-10]) following administration of MK-0677 (ibutamoren mesylate) 25-mg once daily for 24 weeks relative to placebo.;Secondary Objective: (1)the safety and tolerability of MK-0677(2)the change in disability (as measured by the Physical & Movement domain of the Activity Measure for Post-acute Care using Computer Adaptive Testing [henceforth abbreviated as AM-PAC])(3)return to independence in home ambulation and community ambulation (as measured by achievement of a threshold in the Physical & Movement domain of the AM-PAC (4)the change in lower extremity muscle strength (bilateral isometric knee extension) and leg muscle power (stair climbing power)(5)the change in levels of insulin-like growth factor-1 (IGF-1) and insulin-like growth factor binding protein-3 (IGF-BP3)and(6)the change in patient global assessment of improvement.;Primary end point(s): The primary efficacy endpoint, the change from baseline in PFP-10 total score at Week 24, will be assessed using an analysis of covariance (ANCOVA) model with factors, as appropriate, for stratum, study center, treatment, and baseline covariate; the efficacy advantage over placebo will be established by a statistically significant difference between the two treatments. | — |
Countries
Denmark, Germany, Spain, Sweden, United Kingdom
Outcome results
None listed