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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00128115
Recruitment Status : Terminated
First Posted : August 9, 2005
Last Update Posted : January 20, 2016
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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. 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 or disease Intervention/treatment Phase
Hip Fracture Drug: MK0677 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 83 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Proprietary Information - Exploratory (Non-Confirmatory) Trial
Study Start Date : September 2005
Actual Primary Completion Date : August 2007
Actual Study Completion Date : August 2007

Resource links provided by the National Library of Medicine

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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00128115

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Msd Sharp & Dohme Gmbh
Haar, Germany, 85540
MSD (Norge) AS
Drammen, Norway, 3011
Merck Sharp & Dohme De Espana, S.A.E.
Madrid, Spain, 28027
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.
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Study Director: Medical Monitor Merck Sharp & Dohme Corp.

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00128115    
Other Study ID Numbers: 0677-032
First Posted: August 9, 2005    Key Record Dates
Last Update Posted: January 20, 2016
Last Verified: January 2016
Additional relevant MeSH terms:
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Fractures, Bone
Hip Fractures
Wounds and Injuries
Femoral Fractures
Hip Injuries
Leg Injuries