Effect of 12-months testosterone replacement therapy on bone mineral density and markers of bone turnover in testicular cancer survivors–results from a randomized double-blind trial
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Effect of 12-months testosterone replacement therapy on bone mineral density and markers of bone turnover in testicular cancer survivors–results from a randomized double-blind trial. / Jørgensen, P. L.; Kreiberg, M.; Jørgensen, N.; Juul, A.; Oturai, P. S.; Dehlendorff, C.; Lauritsen, J.; Wagner, T.; Rosenvilde, J.; Daugaard, G.; Medici, C. R.; Jørgensen, N. R.; Bandak, M.
I: Acta Oncologica, Bind 62, Nr. 7, 2023, s. 689-695.Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › fagfællebedømt
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TY - JOUR
T1 - Effect of 12-months testosterone replacement therapy on bone mineral density and markers of bone turnover in testicular cancer survivors–results from a randomized double-blind trial
AU - Jørgensen, P. L.
AU - Kreiberg, M.
AU - Jørgensen, N.
AU - Juul, A.
AU - Oturai, P. S.
AU - Dehlendorff, C.
AU - Lauritsen, J.
AU - Wagner, T.
AU - Rosenvilde, J.
AU - Daugaard, G.
AU - Medici, C. R.
AU - Jørgensen, N. R.
AU - Bandak, M.
N1 - Funding Information: The Danish Cancer Society, The Danish Cancer Research Foundation and Rigshospitalet have supported the study. Kiowa Kirin International covered expenses for Tostran and placebo. Publisher Copyright: © 2023 Acta Oncologica Foundation.
PY - 2023
Y1 - 2023
N2 - Background: Testicular cancer survivors (TCS) are at risk of Leydig cell insufficiency, which is a condition characterized by elevated luteinising hormone (LH) in combination with low levels of testosterone. It has been suggested that this condition is associated with impaired metabolic profile and low bone mineral density (BMD). The primary aim of the randomized double-blind trial NCT02991209 was to evaluate metabolic profile after 12-months testosterone replacement therapy (TRT) in TCS with mild Leydig cell insufficiency. Here we present the secondary outcomes of changes in BMD and markers of bone turnover. Methodology: In total, 69 TCS with mild Leydig cell insufficiency were randomized 1:1 to 12 months TRT (n = 35) (Tostran, gel, 2%, applied transdermally, with a maximum daily dose of 40 mg) or placebo (n = 34). BMD and markers of bone turnover were evaluated at baseline, after 6- and 12-months TRT, and 3-months post-treatment. Linear mixed effects models were used to analyse changes in BMD, N-terminal propeptide of type 1 procollagen (P1NP) and C-terminal telopeptide of type I collagen (CTX). Results: After 12 months treatment, TRT was not associated with a statistically significant difference in BMD compared to placebo; total body BMD: 0.01 g/cm2 (95% confidence interval (CI): −0.01 − 0.02), BMD of the lumbar spine: 0.01 g/cm2, (95% CI: −0.01–0.03), BMD of the left femoral neck: 0.00, (95% CI: −0.01–0.02). TRT was associated with a small but statistically significant increase in P1NP: 11.65 µg/L (95% CI: 3.96, 19.35), while there was no difference in CTX. Conclusion: 12 months of TRT did not change BMD, while there was as small and clinically irrelevant increase in P1NP compared to placebo in TCS with mild Leydig cell insufficiency. The findings need validation in a larger cohort.
AB - Background: Testicular cancer survivors (TCS) are at risk of Leydig cell insufficiency, which is a condition characterized by elevated luteinising hormone (LH) in combination with low levels of testosterone. It has been suggested that this condition is associated with impaired metabolic profile and low bone mineral density (BMD). The primary aim of the randomized double-blind trial NCT02991209 was to evaluate metabolic profile after 12-months testosterone replacement therapy (TRT) in TCS with mild Leydig cell insufficiency. Here we present the secondary outcomes of changes in BMD and markers of bone turnover. Methodology: In total, 69 TCS with mild Leydig cell insufficiency were randomized 1:1 to 12 months TRT (n = 35) (Tostran, gel, 2%, applied transdermally, with a maximum daily dose of 40 mg) or placebo (n = 34). BMD and markers of bone turnover were evaluated at baseline, after 6- and 12-months TRT, and 3-months post-treatment. Linear mixed effects models were used to analyse changes in BMD, N-terminal propeptide of type 1 procollagen (P1NP) and C-terminal telopeptide of type I collagen (CTX). Results: After 12 months treatment, TRT was not associated with a statistically significant difference in BMD compared to placebo; total body BMD: 0.01 g/cm2 (95% confidence interval (CI): −0.01 − 0.02), BMD of the lumbar spine: 0.01 g/cm2, (95% CI: −0.01–0.03), BMD of the left femoral neck: 0.00, (95% CI: −0.01–0.02). TRT was associated with a small but statistically significant increase in P1NP: 11.65 µg/L (95% CI: 3.96, 19.35), while there was no difference in CTX. Conclusion: 12 months of TRT did not change BMD, while there was as small and clinically irrelevant increase in P1NP compared to placebo in TCS with mild Leydig cell insufficiency. The findings need validation in a larger cohort.
KW - bone mineral density
KW - hypogonadism
KW - late effects
KW - markers of bone turnover
KW - osteoporosis
KW - Testicular cancer
KW - testosterone
U2 - 10.1080/0284186X.2023.2207218
DO - 10.1080/0284186X.2023.2207218
M3 - Journal article
C2 - 37151105
AN - SCOPUS:85158160094
VL - 62
SP - 689
EP - 695
JO - Acta Oncologica
JF - Acta Oncologica
SN - 1100-1704
IS - 7
ER -
ID: 367090337