Denosumab

Additional information

Pharmacokinetics and dosing

According to the original manufacturer, denosumab pharmacokinetics is similar in men and women [1]. No studies with a clinically relevant sex analysis regarding the dosing of denosumab have been found.

Effects

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 [2]. 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 [5] 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 [6].

Adverse effects

No studies with a clinical relevant sex analysis regarding adverse effects of denosumab have been found.

Reproductive health issues

Denosumab may cause fetal harm when a man treated with denosumab has unprotected sexual intercourse with a pregnant partner [7]. Regarding teratogenic aspects, please consult Janusmed Drugs and Birth Defects (in Swedish, Janusmed fosterpåverkan).