A 24-Week, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Assess the Safety and Efficacy of MK-0677 for the Treatment of Sarcopenia in Patients Recovering From Hip Fracture - MK-0677 Hip Fracture Recovery Study

Phase 1

• Conditions: Sarcopenia; MedDRA version: 8.0 Level: LLT Classification code 10063024

• Registration Number: EUCTR2005-002509-22-ES
• Lead Sponsor: Merck Sharp and Dohme de España

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-05-24
• Study Completion: 2007-08-22
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 320

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

•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).

Study & Design

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