Effects of transdermal testosterone gel on bone turnover markers and bone mineral density in hypogonadal men

Christina Wang, Ronald S. Swerdloff, Ali Iranmanesh, Adrian S Dobs, Peter J. Snyder, Glenn Cunningham, Alvin M. Matsumoto, Thomas Weber, Nancy Berman

Research output: Contribution to journalArticle

Abstract

OBJECTIVE: Androgen replacement has been reported to increase bone mineral density (BMD) in hypogonadal men. We studied the effects of 6 months of treatment with a new transdermal testosterone (T) gel preparation on bone turnover markers and BMD. DESIGN: This was a prospective, randomized, multicentre, parallel clinical trial where 227 hypogonadal men, mean age 51 years (range: 19-68 years) were studied in 16 academic and research institutions in the USA. Subjects were randomized to apply 1% T gel containing 50 or 100 mg T (delivering approximately 510 mg T/day) or two T patches (delivering 5 mg T/day) transdermally for 90 days. At day 91, depending on the serum T concentration, the T gel dose was adjusted upward or downward to 75 mg T/day until day 180. No dose adjustment occurred in the T patch group. MEASUREMENTS: Serum T, free T and oestradiol, bone turnover markers and BMD were measured on days 0, 30, 90 and 180 before and after treatment. RESULTS: Application of T gel 100 mg/day resulted in serum T concentrations 1.4 and 1.9-fold higher than in the T gel 50 mg/day and the T patch groups, respectively. Proportional increases occurred in serum oestradiol. Urine N-telopeptide/crestinine ratio, a marker for bone resorption, decreased significantly (P = 0.0019) only in the T gel 100 mg/day group. Serum bone osteoblastic activity markers (osteocalcin, procollagen and skeletal alkaline phosphatase) increased significantly during the first 90 days of treatment without intergroup differences but declined to beseline thereafter. BMD increased significantly both in the hip (+1.1 ± 0.3%) and spine (+2.2 ± 0.5%) only in the T gel 100 mg/day group (p = 0.0001 ). CONCLUSIONS: Transdermal testosterone gel application for 6 months decreased bone resorption markers and increased osteoblaetlc activity markers for a short period, which resulted in a small but significant increase in BMD. Ongoing long-term studies should answer whether the observed increases in BMD are sustained or continue to be dependent on the dose of testosterone administered.

Original languageEnglish (US)
Pages (from-to)739-750
Number of pages12
JournalClinical Endocrinology
Volume54
Issue number6
DOIs
StatePublished - 2001

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Bone Remodeling
Bone Density
Testosterone
Gels
Bone and Bones
Serum
Bone Resorption
Estradiol
Procollagen
Osteocalcin
Androgens
Alkaline Phosphatase
Hip
Spine
Therapeutics
Clinical Trials
Urine
Research

ASJC Scopus subject areas

  • Endocrinology

Cite this

Effects of transdermal testosterone gel on bone turnover markers and bone mineral density in hypogonadal men. / Wang, Christina; Swerdloff, Ronald S.; Iranmanesh, Ali; Dobs, Adrian S; Snyder, Peter J.; Cunningham, Glenn; Matsumoto, Alvin M.; Weber, Thomas; Berman, Nancy.

In: Clinical Endocrinology, Vol. 54, No. 6, 2001, p. 739-750.

Research output: Contribution to journalArticle

Wang, C, Swerdloff, RS, Iranmanesh, A, Dobs, AS, Snyder, PJ, Cunningham, G, Matsumoto, AM, Weber, T & Berman, N 2001, 'Effects of transdermal testosterone gel on bone turnover markers and bone mineral density in hypogonadal men', Clinical Endocrinology, vol. 54, no. 6, pp. 739-750. https://doi.org/10.1046/j.1365-2265.2001.01271.x
Wang, Christina ; Swerdloff, Ronald S. ; Iranmanesh, Ali ; Dobs, Adrian S ; Snyder, Peter J. ; Cunningham, Glenn ; Matsumoto, Alvin M. ; Weber, Thomas ; Berman, Nancy. / Effects of transdermal testosterone gel on bone turnover markers and bone mineral density in hypogonadal men. In: Clinical Endocrinology. 2001 ; Vol. 54, No. 6. pp. 739-750.
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abstract = "OBJECTIVE: Androgen replacement has been reported to increase bone mineral density (BMD) in hypogonadal men. We studied the effects of 6 months of treatment with a new transdermal testosterone (T) gel preparation on bone turnover markers and BMD. DESIGN: This was a prospective, randomized, multicentre, parallel clinical trial where 227 hypogonadal men, mean age 51 years (range: 19-68 years) were studied in 16 academic and research institutions in the USA. Subjects were randomized to apply 1{\%} T gel containing 50 or 100 mg T (delivering approximately 510 mg T/day) or two T patches (delivering 5 mg T/day) transdermally for 90 days. At day 91, depending on the serum T concentration, the T gel dose was adjusted upward or downward to 75 mg T/day until day 180. No dose adjustment occurred in the T patch group. MEASUREMENTS: Serum T, free T and oestradiol, bone turnover markers and BMD were measured on days 0, 30, 90 and 180 before and after treatment. RESULTS: Application of T gel 100 mg/day resulted in serum T concentrations 1.4 and 1.9-fold higher than in the T gel 50 mg/day and the T patch groups, respectively. Proportional increases occurred in serum oestradiol. Urine N-telopeptide/crestinine ratio, a marker for bone resorption, decreased significantly (P = 0.0019) only in the T gel 100 mg/day group. Serum bone osteoblastic activity markers (osteocalcin, procollagen and skeletal alkaline phosphatase) increased significantly during the first 90 days of treatment without intergroup differences but declined to beseline thereafter. BMD increased significantly both in the hip (+1.1 ± 0.3{\%}) and spine (+2.2 ± 0.5{\%}) only in the T gel 100 mg/day group (p = 0.0001 ). CONCLUSIONS: Transdermal testosterone gel application for 6 months decreased bone resorption markers and increased osteoblaetlc activity markers for a short period, which resulted in a small but significant increase in BMD. Ongoing long-term studies should answer whether the observed increases in BMD are sustained or continue to be dependent on the dose of testosterone administered.",
author = "Christina Wang and Swerdloff, {Ronald S.} and Ali Iranmanesh and Dobs, {Adrian S} and Snyder, {Peter J.} and Glenn Cunningham and Matsumoto, {Alvin M.} and Thomas Weber and Nancy Berman",
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T1 - Effects of transdermal testosterone gel on bone turnover markers and bone mineral density in hypogonadal men

AU - Wang, Christina

AU - Swerdloff, Ronald S.

AU - Iranmanesh, Ali

AU - Dobs, Adrian S

AU - Snyder, Peter J.

AU - Cunningham, Glenn

AU - Matsumoto, Alvin M.

AU - Weber, Thomas

AU - Berman, Nancy

PY - 2001

Y1 - 2001

N2 - OBJECTIVE: Androgen replacement has been reported to increase bone mineral density (BMD) in hypogonadal men. We studied the effects of 6 months of treatment with a new transdermal testosterone (T) gel preparation on bone turnover markers and BMD. DESIGN: This was a prospective, randomized, multicentre, parallel clinical trial where 227 hypogonadal men, mean age 51 years (range: 19-68 years) were studied in 16 academic and research institutions in the USA. Subjects were randomized to apply 1% T gel containing 50 or 100 mg T (delivering approximately 510 mg T/day) or two T patches (delivering 5 mg T/day) transdermally for 90 days. At day 91, depending on the serum T concentration, the T gel dose was adjusted upward or downward to 75 mg T/day until day 180. No dose adjustment occurred in the T patch group. MEASUREMENTS: Serum T, free T and oestradiol, bone turnover markers and BMD were measured on days 0, 30, 90 and 180 before and after treatment. RESULTS: Application of T gel 100 mg/day resulted in serum T concentrations 1.4 and 1.9-fold higher than in the T gel 50 mg/day and the T patch groups, respectively. Proportional increases occurred in serum oestradiol. Urine N-telopeptide/crestinine ratio, a marker for bone resorption, decreased significantly (P = 0.0019) only in the T gel 100 mg/day group. Serum bone osteoblastic activity markers (osteocalcin, procollagen and skeletal alkaline phosphatase) increased significantly during the first 90 days of treatment without intergroup differences but declined to beseline thereafter. BMD increased significantly both in the hip (+1.1 ± 0.3%) and spine (+2.2 ± 0.5%) only in the T gel 100 mg/day group (p = 0.0001 ). CONCLUSIONS: Transdermal testosterone gel application for 6 months decreased bone resorption markers and increased osteoblaetlc activity markers for a short period, which resulted in a small but significant increase in BMD. Ongoing long-term studies should answer whether the observed increases in BMD are sustained or continue to be dependent on the dose of testosterone administered.

AB - OBJECTIVE: Androgen replacement has been reported to increase bone mineral density (BMD) in hypogonadal men. We studied the effects of 6 months of treatment with a new transdermal testosterone (T) gel preparation on bone turnover markers and BMD. DESIGN: This was a prospective, randomized, multicentre, parallel clinical trial where 227 hypogonadal men, mean age 51 years (range: 19-68 years) were studied in 16 academic and research institutions in the USA. Subjects were randomized to apply 1% T gel containing 50 or 100 mg T (delivering approximately 510 mg T/day) or two T patches (delivering 5 mg T/day) transdermally for 90 days. At day 91, depending on the serum T concentration, the T gel dose was adjusted upward or downward to 75 mg T/day until day 180. No dose adjustment occurred in the T patch group. MEASUREMENTS: Serum T, free T and oestradiol, bone turnover markers and BMD were measured on days 0, 30, 90 and 180 before and after treatment. RESULTS: Application of T gel 100 mg/day resulted in serum T concentrations 1.4 and 1.9-fold higher than in the T gel 50 mg/day and the T patch groups, respectively. Proportional increases occurred in serum oestradiol. Urine N-telopeptide/crestinine ratio, a marker for bone resorption, decreased significantly (P = 0.0019) only in the T gel 100 mg/day group. Serum bone osteoblastic activity markers (osteocalcin, procollagen and skeletal alkaline phosphatase) increased significantly during the first 90 days of treatment without intergroup differences but declined to beseline thereafter. BMD increased significantly both in the hip (+1.1 ± 0.3%) and spine (+2.2 ± 0.5%) only in the T gel 100 mg/day group (p = 0.0001 ). CONCLUSIONS: Transdermal testosterone gel application for 6 months decreased bone resorption markers and increased osteoblaetlc activity markers for a short period, which resulted in a small but significant increase in BMD. Ongoing long-term studies should answer whether the observed increases in BMD are sustained or continue to be dependent on the dose of testosterone administered.

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