Testosterone Combined with Electrical Stimulation and Standing: Effect on Muscle and Bone
Technical Report,30 Sep 2015,29 Sep 2016
Kessler Foundation Inc. Foundation Inc. United States
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The study is a prospective, randomized, double blinded, controlled, multi-site clinical trial todetermine the efficacy of a tri-combination intervention to improve musculoskeletal gains in menwith subacute to chronic SCI with low circulating testosterone levels. Participants will be enrolledat Kessler Foundation KF, the University of Louisville-Frazier Rehab UoL, the James J. PetersVA Medical Center JJPVAMC. During year 2 of the study, the Study Team Drs. Forrest, Bauman, and Harkema established a new partnership with a pharmaceutical company AbbVie to supply Drug and Placebo for all potential study participants. Each of the study sites submitted to the pharmaceutical company all requested regulatory documentation for supply of drug to all sites. During Year 2, all FDA requirements were satisfied for the acquisition of the IND number for all sites. In addition, the drugplacebo has been manufactured and shipped to the Kessler site102316. Kessler and JPVAMC received HRPO approval 81816 and 9116respectively. HRPO approval for UoL is pending. Kessler has prescreened 17 participants and currently are screening 10 participants for potential recruitment. Early Year 3 112116, JJPVAMC will be trained at Kessler on all protocol. JJPVAMC will then start screening, and recruitment of participants.
- Anatomy and Physiology