Status:
TERMINATED
Treatment of Sarcopenia in Post-Hip Fracture Patients (0677-032)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Hip Fracture
Eligibility:
All Genders
60+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to demonstrate an improvement in physical functional recovery, following administration of Drug for 24 weeks, in patients who have recently experienced a hip fracture. Thi...
Eligibility Criteria
Inclusion
- Patient has had surgery for a unilateral hip fracture, and is considered to be partially or fully weight bearing after the surgery
- Surgical repair of the fracture has occurred no more than 4 days post hip fracture
- Prior to starting the study medication, the patient is enrolled in a rehabilitation program (as an in-patient or as an out-patient)
- 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)
Exclusion
- Patient has an unstable medical condition
- 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).
- Patient has Type I diabetes
- Patient has Type II diabetes with any of conditions;
- Patient is currently taking more than one anti-hyperglycemic agent, or is taking a single combination anti-hyperglycemic drug containing more than one anti-hyperglycemic medication
- Patient is currently receiving insulin. Note: A short-term course of insulin required for glycemic control post hip fracture surgery is not exclusionary
- Patient has diabetic retinopathy
- 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 has active carpal tunnel syndrome
- Patient was living in a nursing home prior to the hip fracture (Note: - Patients who were 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
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2007
Estimated Enrollment :
83 Patients enrolled
Trial Details
Trial ID
NCT00128115
Start Date
September 1 2005
End Date
August 1 2007
Last Update
January 20 2016
Active Locations (5)
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1
Msd Sharp & Dohme Gmbh
Haar, Germany, 85540
2
MSD (Norge) AS
Drammen, Norway, 3011
3
Merck Sharp & Dohme De Espana, S.A.E.
Madrid, Madrid, Spain, 28027
4
Merck Sharp & Dohme (Sweden) AB
Sollentuna, Sweden, 192 07