The Effectiveness and Safety of Romosozumab and Teriparatide in Postmenopausal Women With Osteoporosis

Abstract

Purpose: The purpose of this observational study was to investigate the effectiveness and safety of romosozumab (ROMO) and teriparatide (TPTD) in a clinical setting.

Methods: A total of 315 postmenopausal women were included based on the reimbursement criteria for ROMO and TPTD at the Department of Endocrinology at Aarhus University Hospital. Criteria for ROMO were bone mineral density (BMD) T-score < -2.5 (femoral neck [FN], total hip [TH], or lumbar spine [LS]) + a fragility fracture (hip, spine, pelvis, distal forearm, or proximal humerus) within 3 years. Criteria for TPTD: within 3 years, ≥ 2 vertebral fractures or 1 vertebral fracture + BMD T-score (FN, TH, or LS) < -3. Data were collected from medical records. The primary end point was percentage change from baseline in BMD (FN, TH, and LS) at month 12. BMD was measured by dual-energy x-ray absorptiometry (DXA).

Results: At month 12, ROMO led to significantly (P < .001) larger increases than TPTD in BMD (FN: 4.8% vs 0.2%, TH: 5.7% vs 0.3%, and LS: 13.7% vs 9.3%). Discontinuation rate was lower with ROMO than with TPTD. Lower incidence of cardiovascular adverse events was observed with ROMO compared to TPTD. Treatment-naïve patients had nonsignificantly higher BMD increases compared to previously treated patients with both ROMO and TPTD.

Conclusion: Treatment with ROMO yields larger increases in BMD than TPTD after 12 months and a higher rate of completion. ROMO was associated with a higher adherence.

Keywords: efficacy; osteoporosis; postmenopausal; romosozumab; safety; teriparatide.