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 1 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. Manufacture of the drug/placebo with randomization across the sites for administration of drug/placebo 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 drug/placebo 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.
Document Details
- Document Type
- Technical Report
- Publication Date
- Oct 01, 2015
- Accession Number
- AD1009869
Entities
People
- Gail F. Forrest