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

Primary Purpose

Hip Fracture

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
MK0677
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hip Fracture

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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; 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

Sites / Locations

  • Msd Sharp & Dohme Gmbh
  • MSD (Norge) AS
  • Merck Sharp & Dohme De Espana, S.A.E.
  • Merck Sharp & Dohme (Sweden) AB
  • Merch Sharp & Dohme Ltd.

Outcomes

Primary Outcome Measures

Proprietary Information - Exploratory (Non-Confirmatory) Trial

Secondary Outcome Measures

Proprietary Information - Exploratory (Non-Confirmatory) Trial

Full Information

First Posted
August 5, 2005
Last Updated
January 19, 2016
Sponsor
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT00128115
Brief Title
Treatment of Sarcopenia in Post-Hip Fracture Patients (0677-032)
Official Title
Proprietary Information - Exploratory (Non-Confirmatory) Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Terminated
Study Start Date
September 2005 (undefined)
Primary Completion Date
August 2007 (Actual)
Study Completion Date
August 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC

4. Oversight

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fracture

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
83 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
MK0677
Primary Outcome Measure Information:
Title
Proprietary Information - Exploratory (Non-Confirmatory) Trial
Secondary Outcome Measure Information:
Title
Proprietary Information - Exploratory (Non-Confirmatory) Trial

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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; 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
Facility Information:
Facility Name
Msd Sharp & Dohme Gmbh
City
Haar
ZIP/Postal Code
85540
Country
Germany
Facility Name
MSD (Norge) AS
City
Drammen
ZIP/Postal Code
3011
Country
Norway
Facility Name
Merck Sharp & Dohme De Espana, S.A.E.
City
Madrid
ZIP/Postal Code
28027
Country
Spain
Facility Name
Merck Sharp & Dohme (Sweden) AB
City
Sollentuna
ZIP/Postal Code
192 07
Country
Sweden
Facility Name
Merch Sharp & Dohme Ltd.
City
Hoddesdon
State/Province
Hertfordshire
ZIP/Postal Code
EN11 9BU
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
21067829
Citation
Adunsky A, Chandler J, Heyden N, Lutkiewicz J, Scott BB, Berd Y, Liu N, Papanicolaou DA. MK-0677 (ibutamoren mesylate) for the treatment of patients recovering from hip fracture: a multicenter, randomized, placebo-controlled phase IIb study. Arch Gerontol Geriatr. 2011 Sep-Oct;53(2):183-9. doi: 10.1016/j.archger.2010.10.004. Epub 2010 Nov 9.
Results Reference
derived

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

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