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DG DISPATCH - ENDO 2000: Testosterone Gel Increases Bone Mineral Density In Hypogonadal Men By Cameron Johnston Special to DG News TORONTO, ON -- June 23, 2000 -- Men using the testosterone gel (AndroGel, Unimed Pharmaceuticals Inc.) have shown a significant improvement in bone mineral density (BMD) over a six-month period. Although these men did not have low BMD at baseline, California researchers say this could offer further protection for those men as they age. The study results were presented in a press conference today at the annual meeting of the Endocrine Society, being held in Toronto, ON, this week. The study compared 227 men who used either the androgen gel in 50 mg or 100 mg doses (n=73 and 78 respectively), or a 5 mg testosterone patch (n=76) daily for a period of six months. The findings were presented by Christina Wang, MD, a professor of medicine at the University of California at Los Angeles medical school and investigator at the Harbor-University of California - Los Angeles Research and Education Institute in Torrance, CA. Dr. Wang said the markers that indicate the level of bone turn-over, urine N-telopeptide and creatinine were decreased significantly in men who used the androgen gel as compared with those who used the testosterone patch. Those who used the higher dose of the testosterone gel showed a significantly greater reduction in N-telepeptide as compared with those in the low dose testosterone or the testosterone patch groups. This indicates less bone resorption in that group. At the same time, there were marked increases in markers for bone osteoblast activity -- osteocalcin, procollagen and bone alkaline phosphatase -- indicating that bone formation was carrying on as expected. There were no significant differences in the levels of osteoblast activity between either of the three groups, and this increase is osteoblast activity lasted only for the first 90 days before returning to baseline levels. At the end of the six-month period, there was a two percent increase in bone mineral density in men who used the higher-dose testosterone gel -- a figure which Dr. Wang said was highly significant. Men who used the lower dose of testosterone gel saw an increase in BMD of slightly more than one percent, which, although not significant, did represent a trend toward improved BMD, she added. The increase in BMD was directly correlated with the dose of testosterone gel. Men who used the testosterone patch had a mean increase in serum testosterone from 8.82 nmol/mL to 14.14 nMol/mL at day 180. Those who used the 100-mg dose of gel increased testosterone from 8.22 nMol/mL to 24.72 nMol/mL. During that time, follicle stimulating hormone (FSH) levels fell by 80 percent in the high dose gel group but by 25 per cent in the testosterone patch group. Similarly, leutenizing hormone (LH) levels fell by 80 percent in the high-dose gel group but by just 40 per-cent in the testosterone patch group. In this study approximately 60 percent of the men had already been on some form of testosterone replacement therapy, and they were discontinued for a period of six weeks, before a baseline bone mineral density, using DEXA (dual energy x-ray absorption spectrometry). The men involved did not have osteoporosis or osteopenia but underwent bone mineral density tests because of their low testosterone levels. BMD was recommended at the six-month mark because their body composition was also being analyzed and there was some concern that some men would withdraw from the study before the end of one year, which would normally be the preferred time to do a BMD test, she explained. "None of these men had prevalent fractures, and we did not do this study to look at the treatment of osteoporosis," she said. "I suspect that not very many of these men had very low T-scores," (which are used to define osteoporosis and osteopenia)." "The most important thing here was the increase in bone mineral density, because BMD is related to fracture rates," she said. Related links: AndroGel and Unimed Pharmaceuticals Inc. E-mail this page to a friend or colleague! To print, use this version