Evaluation of rGH Therapy to Prevent Muscle Atrophy in Patients With ACL Tears

PHASE2CompletedINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

May 31, 2015

Primary Completion Date

October 31, 2018

Study Completion Date

October 31, 2018

Conditions
Rupture of Anterior Cruciate Ligament
Interventions
DRUG

Somatropin

GH dose will be calculated by nomogram estimation of body surface area, and will be administered via subcutaneous injection in the abdominal area twice per day (BID) at a dose of 0.5mg GH per body surface area (BSA) in m2 (0.5mg/m2). Patients will begin GH treatment one week prior to surgery and will continue through 5 weeks after surgery. On the day of surgery, patients will not take GH, but otherwise patients will take GH every day over this 6 week period.

DRUG

Placebo

A placebo diluent that will be administered via subcutaneous injection in the abdominal area twice per day (BID) at a dose of the equivalent concentration of 0.5mg GH per body surface area (BSA) in m2 (0.5mg/m2). Patients will begin treatment one week prior to surgery and will continue through 5 weeks after surgery. On the day of surgery, patients will not take medication, but otherwise patients will take medication every day over this 6 week period.

Trial Locations (1)

48109

University of Michigan, Ann Arbor

All Listed Sponsors
collaborator

Hospital for Special Surgery, New York

OTHER

lead

University of Michigan

OTHER

NCT02420353 - Evaluation of rGH Therapy to Prevent Muscle Atrophy in Patients With ACL Tears | Biotech Hunter | Biotech Hunter