Testosterone Combined with Electrical Stimulation and Standing: Effect on Muscle and Bone
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 drug/placebo has been manufactured and shipped to the Kessler site (10/23/16). Kessler, JPVAMC and UoL received HRPO approval 8/18/16, 9/1/16 and UoL HRPO approval (3/17/17) respectively. In Year 3 JPVAMC, and UoL received training for drug/placebo and electrical stimulation intervention at Kessler on 11/16/16 and UoL (1/17/171/18/17), 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.
Document Details
- Document Type
- Technical Report
- Publication Date
- Oct 01, 2017
- Accession Number
- AD1043147
Entities
People
- Gail F. Forrest