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Accession Number:
AD1043147
Title:
Testosterone Combined with Electrical Stimulation and Standing: Effect on Muscle and Bone
Descriptive Note:
Technical Report,30 Sep 2016,29 Sep 2017
Corporate Author:
Kessler Foundation West Orange United States
Report Date:
2017-10-01
Pagination or Media Count:
24.0
Abstract:
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 2 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. During Year 2, all FDA requirements were satisfied for the acquisition of the IND number for all sites. The drugplacebo has been manufactured and shipped to the Kessler site 102316. Kessler, JPVAMC and UoL received HRPO approval 81816, 9116 and UoL HRPO approval 31717 respectively. In Year 3 JPVAMC, and UoL received training for drugplacebo and electrical stimulation intervention at Kessler on 111616 and UoL 1171711817, respectively. Data is entered into ITW database as per grant procedures and SOW. All three sites started screening and enrollment. To date, Kessler, UoL and JJPMVMC have prescreened 68 individuals, screened consented onsite 18, 3 are currently screening, 2 have completed 5 months intervention phase, one is currently training. Two are in follow-up of phase of protocol.
Distribution Statement:
APPROVED FOR PUBLIC RELEASE
