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 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 drug/placebo has been manufactured and shipped to the Kessler site(10/23/16). Kessler and JPVAMC received HRPO approval 8/18/16 and 9/1/16respectively. HRPO approval for UoL is pending. Kessler has prescreened 17 participants and currently are screening 10 participants for potential recruitment. Early Year 3 (11/21/16), JJPVAMC will be trained at Kessler on all protocol. JJPVAMC will then start screening, and recruitment of participants.
Document Details
- Document Type
- Technical Report
- Publication Date
- Oct 01, 2016
- Accession Number
- AD1033209
Entities
People
- Gail F. Forrest