Drug products: Prolia, XGEVA
ATC code: M05BX04
Studies about differences between men and women on the effect and safety of denosumab are lacking. Results from studies in only men or only women indicate that the effect of bone mineral density (BMD) is similar in both sexes.
According to the original manufacturer, denosumab pharmacokinetics is similar in men and women . No studies with a clinically relevant sex analysis regarding the dosing of denosumab have been found.
Well-powered trials evaluating clinical fracture risk reduction in male osteoporosis are lacking. To estimate the anti-fracture efficacy of denosumab in men, trials have used assumptions concerning drug efficacy derived from trials in postmenopausal women . For instance, percentage change from baseline to month 12 in lumbar spine BMD in women in the FREEDOM trial (placebo 0.7 vs. denosumab 4.8) was comparable to men in the ADAMO trial (placebo 1.0 vs. denosumab 4.8) [2-4]. According to one reference  there is a small ongoing not yet published study of the effect of treatment with denosumab in men with primary osteoporosis.
Dose exposure-response relationship for denosumab was determined in patients with bone metastases from solid tumors. Patients (92 men, 281 women) received denosumab as single or multiple subcutaneous doses ranging from 30-180 mg administrated every 4 or 12 weeks for up to 3 years. Denosumab efficacy and potency did not differ between men and women .
No studies with a clinical relevant sex analysis regarding adverse effects of denosumab have been found.
Denosumab may cause fetal harm when a man treated with denosumab has unprotected sexual intercourse with a pregnant partner . Regarding teratogenic aspects, please consult Janusmed Drugs and Birth Defects (in Swedish, Janusmed fosterpåverkan).
Date of litterature search: 2014-08-07
Reviewed by: Mia von Euler
Approved by: Karin Schenck-Gustafsson