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| ID | Type | Description | Link |
|---|---|---|---|
| 2005_028 |
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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).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MK0677 | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Proprietary Information - Exploratory (Non-Confirmatory) Trial |
| Measure | Description | Time Frame |
|---|---|---|
| Proprietary Information - Exploratory (Non-Confirmatory) Trial |
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Inclusion Criteria:
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 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
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Msd Sharp & Dohme Gmbh | Haar | 85540 | Germany | |||
| MSD (Norge) AS |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21067829 | Derived | 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. |
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| ID | Term |
|---|---|
| D006620 | Hip Fractures |
| ID | Term |
|---|---|
| D005264 | Femoral Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D025981 | Hip Injuries |
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| ID | Term |
|---|---|
| C094817 | ibutamoren mesylate |
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| Drammen |
| 3011 |
| Norway |
| Merck Sharp & Dohme De Espana, S.A.E. | Madrid | Madrid | 28027 | Spain |
| Merck Sharp & Dohme (Sweden) AB | Sollentuna | 192 07 | Sweden |
| Merch Sharp & Dohme Ltd. | Hoddesdon | Hertfordshire | EN11 9BU | United Kingdom |
| D007869 |
| Leg Injuries |