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CRCU

Clinical Research Computing Unit

Testosterone Trials (TTRIALS)

Testosterone Trials (TTRIALS)

May 1, 2009

Funding: NIA
Investigators: Snyder, PJ; Ellenberg, SS

The CRCU collaborated with the Testosterone Trial Steering Committee for four years in the development of this randomized, placebo-controlled, double-blind study of seven coordinated trials. This preliminary period included a feasibility pilot study and a validation study of several standard instruments using the interactive voice response system. The multi-center set of trials include 12 clinical sites geographically distributed across the United States, a central laboratory, investigational drug service, cognitive function reading center, interactive voice response calling center and prostate biopsy reading center, and pharmacogenomic laboratory.

The Testosterone Trial was awarded by the National Institute on Aging (NIA) in May 2009. The Data Coordinating Center at the University of Pennsylvania provided comprehensive project management, regulatory and site management services for this research network, which included developing a secure www-based DMS for collection, centralized storage and reporting of all multi-site study data, a study website, and all of the associated tools and technology to conduct the trial. Administrative support was provided by the DCC which included all coordination, communication and documentation activities associated with the design, development and implementation of the research network and study. The DCC managed all committees, Steering Committee meetings and Data and Safety Monitoring Board meetings.

The trial reached its projected goals in June 2013 with 788 men enrolled into the trial. The trial completed participant follow-up visits in June 2015 and conducted study close-out activities. The Investigators, Biostatisticians and DCC team have  been performing extensive data analyses and manuscript development over the last few year. The trial published its main outcome paper in the New England Journal of Medicine in February 2016 (Snyder PJ, Bhasin S, Cunningham GR, et al. N Engl J Med. 2016 Feb 18;374(7):611-24. doi: 10.1056/NEJMoa1506119.; PMC5209754)

Publications

2017

Testosterone Treatment and Cognitive Function in Older Men With Low Testosterone and Age-Associated Memory Impairment. Resnick SM, Matsumoto AM, Stephens-Shields AJ, Ellenberg SS, Gill TM, Shumaker SA, Pleasants DD, Barrett-Connor E, Bhasin S, Cauley JA, Cella D, Crandall JP, Cunningham GR, Ensrud KE, Farrar JT, Lewis CE, Molitch ME, Pahor M, Swerdloff RS, Cifelli D, Anton S, Basaria S, Diem SJ, Wang C, Hou X, Snyder PJ. JAMA. 2017 Feb 21;317(7):717-727. doi:10.1001/jama.2016.21044..

Testosterone Treatment and Coronary Artery Plaque Volume in Older Men With Low Testosterone. Budoff MJ, Ellenberg SS, Lewis CE, Mohler ER 3rd, Wenger NK, Bhasin S, Barrett-Connor E, Swerdloff RS, Stephens-Shields A, Cauley JA, Crandall JP, Cunningham GR, Ensrud KE, Gill TM, Matsumoto AM, Molitch ME, Nakanishi R, Nezarat N, Matsumoto S, Hou X, Basaria S, Diem SJ, Wang C, Cifelli D, Snyder PJ. JAMA. 2017 Feb 21;317(7):708-716. doi: 10.1001/jama.2016.21043.

Association of Testosterone Levels With Anemia in Older Men: A Controlled Clinical Trial. Roy CN, Snyder PJ, Stephens-Shields AJ, Artz AS, Bhasin S, Cohen HJ, Farrar JT, Gill TM, Zeldow B, Cella D, Barrett-Connor E, Cauley JA, Crandall JP, Cunningham GR, Ensrud KE, Lewis CE, Matsumoto AM, Molitch ME, Pahor M, Swerdloff RS, Cifelli D, Hou X, Resnick SM, Walston JD, Anton S, Basaria S, Diem SJ, Wang C, Schrier SL, Ellenberg SS. JAMA Intern Med. 2017 Feb 21. doi: 10.1001/jamainternmed.2016.9540. [Epub ahead of print]

Effect of Testosterone Treatment on Volumetric Bone Density and Strength in Older Men With Low Testosterone: A Controlled Clinical Trial. Snyder PJ, Kopperdahl DL, Stephens-Shields AJ, Ellenberg SS, Cauley JA, Ensrud KE, Lewis CE, Barrett-Connor E, Schwartz AV, Lee DC, Bhasin S, Cunningham GR, Gill TM, Matsumoto AM, Swerdloff RS, Basaria S, Diem SJ, Wang C, Hou X, Cifelli D, Dougar D, Zeldow B, Bauer DC, Keaveny TM. JAMA Intern Med. 2017 Feb 21. doi:10.1001/jamainternmed.2016.9539. [Epub ahead of print].

2016

Serum Testosterone (T) Level Variability in T Gel-Treated Older Hypogonadal Men: Treatment Monitoring Implications. Swerdloff RS, Pak Y, Wang C, Liu PY, Bhasin S, Gill TM, Matsumoto AM, Pahor M, Surampudi P, Snyder PJ. J Clin Endocrinol Metab. 2015 Sep;100(9):3280-7. doi: 10.1210/JC.2015-1542. Epub 2015 Jun 29.; PMC4570167.

Testosterone Treatment and Sexual Function in Older Men With Low Testosterone Levels. Cunningham GR, Stephens-Shields AJ, Rosen RC, Wang C, Bhasin S, Matsumoto AM, Parsons JK, Gill TM, Molitch ME, Farrar JT, Cella D, Barrett-Connor E, Cauley JA, Cifelli D, Crandall JP, Ensrud KE, Gallagher L, Zeldow B, Lewis CE, Pahor M, Swerdloff RS, Hou X, Anton S, Basaria S, Diem SJ, Tabatabaie V, Ellenberg SS, Snyder PJ. J Clin Endocrinol Metab. 2016 Aug;101(8):3096-104. doi: 10.1210/jc.2016-1645. Epub 2016 Jun 29.;PMC4971331 [Available on 2017-08-01]

Effects of Testosterone Treatment in Older Men. Snyder PJ, Bhasin S, Cunningham GR, Matsumoto AM, Stephens-Shields AJ, Cauley JA, Gill TM, Barrett-Connor E, Swerdloff RS, Wang C, Ensrud KE, Lewis CE, Farrar  JT, Cella D, Rosen RC, Pahor  M, Crandall JP, Molitch ME, Cifelli D, Dougar D, Fluharty L, Resnick SM, Storer TW, Anton S, Basaria S, Diem SJ, Hou X, Mohler ER 3rd, Parsons JK, Wenger NK, Zeldow B, Landis JR, Ellenberg SS; Testosterone Trials Investigators. N Engl J Med. 2016 Feb 18;374(7):611-24. doi: 10.1056/NEJMoa1506119.; PMC5209754

2015

The Cardiovascular Trial of the Testosterone Trials: rationale, design, and baseline data of a clinical trial using computed tomographic imaging to assess the progression of coronary atherosclerosis. Abd Alamir M, Ellenberg SS, Swerdloff RS, Wenger NK, Mohler ER 3rd, Lewis CE, Barrett-Conner E, Nakanishi R, Darabian S, Alani A, Matsumoto S, Nezarat N, Snyder PJ, Budoff MJ. Coron Artery Dis. 2016 Mar;27(2):95-103. Epub 2015 Nov 9; PMC4738150 [Available on 2017-03-01]

Comparison of interactive voice response (IVR) with paper administration of instruments to assess functional status, sexual function, and quality of life in elderly men. Rosen RC, Stephens-Shields AJ, Cunningham GR, Cifelli D, Cella D, Farrar JT, Barrett-Connor E, Lewis CE, Pahor M, Hou X, Snyder PJ. Qual Life Res. 2016 Apr;25(4):811-21. Epub 2015 Sep 10; PMC4786466

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