Trial reportBMC medicine2025
Effect of a single-dose denosumab on mineral homeostasis in infertile men: insights from a pilot intervention study and a randomized controlled trial.
Trial report in BMC medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03030196 (Denosumab and Male Infertility), which is not on this map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Denosumab and Male Infertility: a Randomized Controlled Double-blinded Intervention Study
Who cites it
0 citing papers in PubMed.
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Authors and funding
8 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundDenosumab, a drug that inhibits RANKL to reduce bone resorption in osteoporotic postmenopausal women, has been shown to improve semen quality in a subgroup of infertile men. This study aimed to investigate the effects of denosumab on mineral homeostasis in young infertile men.
methodsSecondary data from two clinical trials designed to test the effect on semen quality were used: (1) a pilot intervention study with 12 men receiving a single-dose of 60 mg denosumab and (2) a single-center, double-blinded, randomized clinical trial, where 100 infertile men were randomized 1:1 to receive denosumab 60 mg once sc. or placebo. A linear mixed model for repeated measures was employed to analyze data from follow-up samples.
resultsIn the pilot intervention study, denosumab treatment induced a decrease in ionized calcium 5, 20, 40, and 80 days after treatment compared with baseline (all p < 0.05). Serum phosphate decreased on all time points up to and including day 40 (all p < 0.05), while alkaline phosphatase was only lowered at 40 days and onwards (p = 0.014). Serum PTH increased significantly at all time points up to and including day 80 (p = 0.026). One hundred eighty days after treatment, all reported analyses were comparable to baseline levels. The observed temporal changes were confirmed in the RCT with differences in serum calcium (p < 0.001) and phosphate (p < 0.001) on day 14, PTH (p < 0.002), and alkaline phosphatase (p < 0.001) on days 80 and 160. Denosumab treatment had no significant effect on vitamin D status, renal function, or serum albumin concentration after 80 and 160 days.
conclusionsSmall but significant changes in mineral homeostasis and bone mineral content were observed but the changes were transient and normalized after treatment cessation. A single injection of denosumab in infertile men appears to have no major long-term impact on bone or mineral homeostasis.
trial registrationClinicalTrials.gov NCT03030196. Registered January 24, 2017.
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