Treatment of Sarcopenia in Post-Hip Fracture Patients (0677-032)

Merck Sharp & Dohme (MSD)

Status and phase

Terminated

Phase 2

Conditions

Hip Fracture

Treatments

Drug: MK0677

Study type

Interventional

Funder types

Industry

Identifiers

NCT00128115

0677-032

2005_028

Details and patient eligibility

About

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. This study will also evaluate the safety and tolerability of Drug.

This is an early phase trial and some specific protocol information is proprietary and not publicly available at this time. (Full information is available to trial participants).

Enrollment

83 patients

Sex

All

Ages

60+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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;
1. 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
2. Patient is currently receiving insulin. Note: A short-term course of insulin required for glycemic control post hip fracture surgery is not exclusionary
3. Patient has diabetic retinopathy
4. 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