Therapeutic Research

Abstract

Purpose：To confirm the safety and efficacy of long‒term treatment with denosumab in patients with osteoporosis in daily clinical practice. 　Methods：This is an ongoing, 3‒year, prospective, observational, cohort study in patients with osteoporosis who started treatment with denosumab（Pralia(R)）60 mg every 6 months. Assessed outcomes included demographic and treatment data, concomitant medications, adverse events（AEs）, adverse drug reactions（ADRs）, efficacy（bone mineral density［BMD］, bone turnover markers［BTM］）and laboratory parameters. The results of the interim analysis are reported here. 　Results：A total of 3609 patients were enrolled, 3373 patients were included （mean age, 75.6 years；female, 89.7％）. A total of 221 ADRs were reported in 182 patients （5.4％）. The most common ADR were hypocalcaemia（n＝84, 2.5％）, hypophosphatemia （n＝19, 0.6％）and nausea（n＝8, 0.2％）. A total of 11 serious ADRs were reported in 10 patients. Osteonecrosis of the jaw（ONJ）was reported in 6 patients（1 case confirmed）. BMD of both the lumbar spine and total hip increased significantly at all timepoints（3, 6 and 12 months）. The results of subgroup analyses suggest that the efficacy of denosumab is independent of sex, age, type of osteoporosis, prior bisphosphonate use and comorbidities. BTMs decreased significantly after 3 months after the first dose of denosumab and these reductions were sustained at 12 months. 　Conclusions：The results of this interim analysis suggest that denosumab is safe and effective in Japanese patients with osteoporosis in daily clinical practice.