Progressive improvement of T-scores in middle-aged men with osteoporosis upon long-term treatment with testosterone

Program: Abstracts - Orals, Featured Poster Presentations, and Posters
Session: SAT 224-247-Osteoporosis I
Clinical
Saturday, June 15, 2013: 1:45 PM-3:45 PM
Expo Halls ABC (Moscone Center)

Poster Board SAT-233
Louis J Gooren*1, Ahmad Haider2, Abdulmaged M Traish3, Gheorghe Doros4, Ulrich Meergans5 and Farid Saad6
1VU University Medical Center, Amsterdam, Netherlands, 2Private Urology Practice, Bremerhaven, Germany, 3Boston Univ Sch of Med, Boston, MA, 4Boston University School of Public Health, Boston, MA, 5DRK-Krankenanst. Wesermuende Seepark-Klinik, Langen, Germany, 6Bayer Pharma AG, Berlin, Germany
Introduction: Numerous studies point to the significance of normal serum testosterone to maintain bone mineral density (BMD) at various stages of life. Testosterone deficiency leads to loss of BMD and testosterone treatment has a beneficial effect. This study investigated the effects of normalizing serum testosterone on BMD in 36 men with osteoporosis who had consulted an orthopedic surgeon and who were diagnosed as testosterone deficient. 
Methods: Cumulative, prospective, registry study of men (mean age: 54.89 ± 6.31 years) with testosterone levels below 12.1 nmol/L. Their T scores were -2.99±0.4 (minimum -3.90, maximum -2.60). They received parenteral testosterone undecanoate 1000 mg/12 weeks following an initial 6-week interval for up to five years. After one year, 36 men were included in the registry, after two years, 32 men, after three years, 26 men, after four years, 10 men, after five years, 4 men. The declining numbers do not reflect drop-out rates but are a result of the registry design. New patients are consecutively entered once they have completed one year of treatment.
Results: Over the 5 year period there was a significant improvement of the T-score in these men. The mean T-score decreased from -2.99±0.4 (minimum: -3.90; maximum: -2.60) at baseline to -2.62±0.34 at 12 months, -2.29±0.32 at 24 months, -2.03±0.35 at 36 months, -1.75±0.2 at 48 months and -1.58±0.19 at 60 months without reaching a plateau. The improvement was progressive: each year of testosterone treatment led to a significant further improvement of the T-score (p<0.0001 vs baseline and vs previous year).
Conclusions: Normalizing of serum testosterone leads to an improvement of bone mineral density and this improvement is progressive throughout the time period of testosterone administration.

Disclosure: AH: Speaker, Bayer Pharma AG, Speaker, Takeda. AMT: Investigator, Bayer Pharma AG. GD: , Bayer Pharma AG. FS: Employee, Bayer Pharma AG. Nothing to Disclose: LJG, UM

*Please take note of The Endocrine Society's News Embargo Policy at http://www.endo-society.org/endo2013/media.cfm

Sources of Research Support: The study was partially supported by Bayer Pharma AG who paid for data entry and statistical analyses.