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: 315 postmenopausal women were included based on the reimbursement criteria for ROMO and TPTD at the Department of Endocrinology at Aarhus University Hospital. ROMO 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. TPTD Within 3 years ≥2 vertebral fractures or 1 vertebral fracture + BMD T-score (FN, TH, or LS) <-3. Data was 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 DXA. RESULTS: At month 12 ROMO led to significantly (p<0.001) 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 non-significantly higher BMD increases compared to previously treated patients with both ROMO and TPTD. CONCLUSION: Treatment with romosozumab yields larger increases in bone mineral density than teriparatide after 12 months and a higher rate of completion.