EFFICACY OF ROMOSOZUMAB FOR GLUCOCORTICOID-INDUCED OSTEOPOROSIS IN PATIENTS WITH RHEUMATIC DISEASES; A PROSPECTIVE STUDY
Authors: Kawazoe M et al.
The efficacy of romosozumab (ROMO) in patients with postmenopausal osteoporosis and men with osteoporosis has been demonstrated in clinical trials. However, the effectiveness of ROMO in glucocorticoid-induced osteoporosis (GIO) is not clear. The purpose of this study was to evaluate the efficacy of ROMO compared to existing therapy by measuring bone mineral density (BMD) in patients recently initiated on glucocorticoid therapy.
In this randomized, prospective, interventional study patients with rheumatic diseases who had not previously received osteoporosis treatment and were newly treated with prednisolone (PDN) ≥15 mg/day were randomly assigned to receive either ROMO, denosumab (DMAb), or a bisphosphonate (BP). They were stratified at randomization according to age, sex, dose of PDN and T-scores of the lumbar spine or femoral neck. BMD of the lumbar spine (L2-L4) and femoral neck was measured at 0, 6, 12 months and serum bone turnover markers at 0, 3, 6, 9 and 12 months after initiation of glucocorticoid therapy.
Ten patients were assigned to the ROMO group, 14 to the DMAb group, and 14 to the BP group. The mean percent change of lumbar spine BMD from baseline at 12 months was greatest for the ROMO group among the three groups (ROMO; 5.7 ± 9.8%, DMAb; 5.2 ± 6.0%, BP; 0.5 ± 5.1%). The mean change of femoral neck BMD at 12 months was greatest for the DMAb group (ROMO; -2.2 ± 6.0%, DMAb; 2.1 ± 3.7%, BP; -2.9 ± 5.8%). Serum N-terminal propeptide of type I procollagen (P1NP) and osteocalcin (OC) decreased in all three groups, but the change was smaller in the ROMO group. Serum bone resorption markers, N-telopeptide crosslinked of type I collagen (NTX) and tartrate-resistant acid phosphatase isoform 5b (TRACP-5b) decreased in all groups.
Under treatment with prednisone ≥ 15 mg/day, patients treated with ROMO or DMAb had a similar but greater increase in lumbar spine BMD than patients under BP treatment. Femoral neck BMD increased only in the DMAb patients and decreased in the ROMO and BP treated patients. Bone turnover markers (N-terminal propeptide of type I procollagen (P1NP), osteocalcin (OC), N-telopeptide crosslinked of type I collagen (NTX) and tartrate-resistant acid phosphatase isoform 5b (TRACP-5b)) decreased in all groups, but P1NP decreased less with ROMO.
This randomized, prospective, interventional study implies that Romosozumab is effective in glucocorticoid-induced osteoporosis in terms of BMD and biomarkers. But DMAb seems to be more effective since it increased BMD in both lumbar spine and femoral neck, whereas ROMO and BP only in the lumbar spine.