Testosterone Combined with Electrical Stimulation and Standing: Effect on Muscle and Bone
Technical Report,30 Sep 2014,29 Sep 2015
Kessler Foundation West Orange United States
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The study is a prospective, randomized, double blinded, controlled, multi-site clinical trial to determine the efficacy of a tri combination intervention to improve musculoskeletal gains in men with subacute to chronic SCI with low circulating testosterone levels. Participants will be enrolled at Kessler Foundation KF, the University of Louisville-Frazier Rehab UoL, the James J. Peters VA Medical Center JJPVAMC. During year 1 of the study, the Study Team Drs. Forrest,Bauman, and Harkema established a new partnership with a pharmaceutical company AbbVieto supply Drug and Placebo for all potential study participants. Each of the study sites submitted to the pharmaceutical company all requested regulatory documentation. Manufacture of the drugplacebo with randomization across the sites for administration of drugplacebo will be completed in early Year 2 of the study. Kessler submitted all required documentation to the FDA to obtain an IND number and approval for the use of drugplacebo and electrical stimulation, as specified in the study protocol. Kessler purchased electrical stimulators for use at the study sites. Local IRB approval at KF was completed. IRB approvals at UoL and JJPVAMC are pending. The Manual of Operation Procedures and the Case Report Forms have also been completed.