Osteoporosis, bone & mineral

Effect of Denosumab on Sperm Concentration in Men With Severe Oligospermia: A Randomized Controlled Trial

J Clin Endocrinol MetabPublished Randomised controlled trial

Authors' conclusion

This RCT showed that denosumab did not improve sperm concentration or alter reproductive hormones compared to placebo. Denosumab is not superior to the vitamin D- and calcium-supplemented men in the placebo group.

Study context

Population
Men with severe oligospermia prospectively selected by serum anti-Müllerian hormone (AMH) and testicular size39 completed
Participants
42 men
Comparison
Single SC injection of denosumab 60 mg vs placebo
  • Denosumabn = 28
  • Placebon = 14reference
Primary endpoint
Improvement in sperm concentration
Follow-up
Day 80
Methodological detailsdouble-blinded, placebo-controlled, single-center, randomized 2:1
  • Double-blinded
  • Placebo-controlled
  • Single-center
  • Randomized 2:1

Primary result

As reported in the abstract

Sperm concentration and total sperm count
  • No differences in sperm concentration or total sperm count between denosumab and placebo

Further findings

Serum testosterone, LH, FSH, inhibin B, AMH

No differences in serum testosterone, LH, FSH, inhibin B or AMH

Change from baseline · baseline to day 80

Increase in sperm concentration and total sperm count, but not serum inhibin B, with both denosumab and placebo

Original publication

Effect of Denosumab on Sperm Concentration in Men With Severe Oligospermia: A Randomized Controlled Trial. J Clin Endocrinol Metab. Published 27 August 2025. doi:10.1210/clinem/dgaf481

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