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

This study has been terminated.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00128115
First received: August 5, 2005
Last updated: May 20, 2013
Last verified: May 2013
  Purpose

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).


Condition Intervention Phase
Hip Fracture
Drug: MK0677
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Proprietary Information - Exploratory (Non-Confirmatory) Trial

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Proprietary Information - Exploratory (Non-Confirmatory) Trial

Secondary Outcome Measures:
  • Proprietary Information - Exploratory (Non-Confirmatory) Trial

Study Start Date: July 2005
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00128115

Locations
Germany
Msd Sharp & Dohme Gmbh
Haar, Germany, 85540
Norway
MSD (Norge) AS
Drammen, Norway, 3011
Spain
Merck Sharp & Dohme De Espana, S.A.E.
Madrid, Spain, 28027
Sweden
Merck Sharp & Dohme (Sweden) AB
Sollentuna, Sweden, 192 07
United Kingdom
Merch Sharp & Dohme Ltd.
Hoddesdon, Hertfordshire, United Kingdom, EN11 9BU
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

No publications provided by Merck Sharp & Dohme Corp.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00128115     History of Changes
Other Study ID Numbers: 2005_028
Study First Received: August 5, 2005
Last Updated: May 20, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Fractures, Bone
Hip Fractures
Wounds and Injuries
Femoral Fractures
Hip Injuries
Leg Injuries

ClinicalTrials.gov processed this record on April 23, 2014