Effect of Testosterone Treatment on Volumetric Bone Density and Strength in Older Men With Low Testosterone: A Controlled Clinical Trial
| Autor: | Susan S. Ellenberg, Denise Cifelli, Thomas M. Gill, Ronald S. Swerdloff, Alisa J. Stephens-Shields, Kristine E. Ensrud, Ann V. Schwartz, Cora E. Lewis, Glenn R. Cunningham, Douglas C. Bauer, Peter J. Snyder, Tony M. Keaveny, Bret Zeldow, Jane A. Cauley, Christina Wang, Xiaoling Hou, Elizabeth Barrett-Connor, Darlene Dougar, Susan J. Diem, Alvin M. Matsumoto, Shalender Bhasin, David Lee, David L. Kopperdahl, Shehzad Basaria |
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| Rok vydání: | 2017 |
| Předmět: |
Male
Aging Bone density law.invention 0302 clinical medicine Absorptiometry Photon Randomized controlled trial law Bone Density Medicine Testosterone 030212 general & internal medicine Quantitative computed tomography Tomography Lumbar Vertebrae medicine.diagnostic_test Drug Administration Routes Photon X-Ray Computed Testosterone Gel medicine.anatomical_structure Treatment Outcome 6.1 Pharmaceuticals Public Health and Health Services Androgens Spinal Fractures Drug Monitoring medicine.medical_specialty Clinical Trials and Supportive Activities Clinical Sciences Urology 030209 endocrinology & metabolism Lumbar vertebrae Placebo Article 03 medical and health sciences Double-Blind Method Clinical Research Opthalmology and Optometry Internal Medicine Humans Absorptiometry Aged business.industry Hip Fractures Prevention Evaluation of treatments and therapeutic interventions Correction Testosterone (patch) Surgery Musculoskeletal Osteoporosis business Tomography X-Ray Computed Body mass index |
| Zdroj: | JAMA internal medicine, vol 177, iss 4 |
| ISSN: | 2168-6114 |
| Popis: | ImportanceAs men age, they experience decreased serum testosterone concentrations, decreased bone mineral density (BMD), and increased risk of fracture.ObjectiveTo determine whether testosterone treatment of older men with low testosterone increases volumetric BMD (vBMD) and estimated bone strength.Design, setting, and participantsPlacebo-controlled, double-blind trial with treatment allocation by minimization at 9 US academic medical centers of men 65 years or older with 2 testosterone concentrations averaging less than 275 ng/L participating in the Testosterone Trials from December 2011 to June 2014. The analysis was a modified intent-to-treat comparison of treatment groups by multivariable linear regression adjusted for balancing factors as required by minimization.InterventionsTestosterone gel, adjusted to maintain the testosterone level within the normal range for young men, or placebo gel for 1 year.Main outcomes and measuresSpine and hip vBMD was determined by quantitative computed tomography at baseline and 12 months. Bone strength was estimated by finite element analysis of quantitative computed tomography data. Areal BMD was assessed by dual energy x-ray absorptiometry at baseline and 12 months.ResultsThere were 211 participants (mean [SD] age, 72.3 [5.9] years; 86% white; mean [SD] body mass index, 31.2 [3.4]). Testosterone treatment was associated with significantly greater increases than placebo in mean spine trabecular vBMD (7.5%; 95% CI, 4.8% to 10.3% vs 0.8%; 95% CI, -1.9% to 3.4%; treatment effect, 6.8%; 95% CI, 4.8%-8.7%; P |
| Databáze: | OpenAIRE |
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