Summary: In a J Clin Endocrinol Metab randomized trial, Treatment with ROMO significantly increased lumbar spine BMD in glucocorticoid-treated patients, suggesting that ROMO is effective for GIOP. Key reported results included Eleven patients were assigned to the ROMO group, 14 to the DMAb group, and 14 to the BP group.
PICO Summary
| Element | Detail |
|---|---|
| Population | Patients with rheumatic diseases who had not previously received treatment for osteoporosis and were newly treated with prednisolone 15 mg/day or more were randomly assigned to receive ROMO, denosumab (DMAb), or bisphosphonates (BP). After the initiation of glucocorticoid therapy, we measured the bone mineral density (BMD) of the lumbar spine, femoral neck, and total hip every 6 months and bone turnover markers every 3… |
| Intervention | Patients with rheumatic diseases who had not previously received treatment for osteoporosis and were newly treated with prednisolone 15 mg/day or more were randomly assigned to receive ROMO, denosumab (DMAb), or bisphosphonates (BP). |
| Comparison | Comparator details are reported in the abstract methods. |
| Outcome | Eleven patients were assigned to the ROMO group, 14 to the DMAb group, and 14 to the BP group. The median [25th to 75th percentile] percent change in lumbar spine BMD from baseline at 12 months was the greatest in the ROMO group (ROMO: 8.6 [3.1-12.4]%, DMAb: 3.3 [1.5-6.2]%, BP: -0.4 [-3.4-1.1]%). Among bone formation markers, serum levels of bone alkaline phosphatase were slightly elevated in the ROMO group, whereas those of N-terminal propeptide of type I procollagen and osteocalcin decreased in all 3 groups… |
Comparison of Efficacy of Romosozumab With Denosumab and...
Primary RCT · Bone & mineral
Treatment with ROMO significantly increased lumbar spine BMD in glucocorticoid-treated patients, suggesting that ROMO is effective for GIOP. CLINICAL TRIAL NUMBER: UMIN000037239.
Expert Commentary
This J Clin Endocrinol Metab randomized trial evaluated Comparison of Efficacy of Romosozumab With Denosumab and Risedronate in Patients Newly Initiating Glucocorticoid Therapy. The abstract describes the study as follows: Patients with rheumatic diseases who had not previously received treatment for osteoporosis and were newly treated with prednisolone 15 mg/day or more were randomly assigned to receive ROMO, denosumab (DMAb), or bisphosphonates (BP). After the initiation of glucocorticoid therapy, we measured the… The main reported results were: Eleven patients were assigned to the ROMO group, 14 to the DMAb group, and 14 to the BP group. The median [25th to 75th percentile] percent change in lumbar spine BMD from baseline at 12 months was the greatest in the ROMO group (ROMO: 8.6 [3.1-12.4]%, DMAb: 3.3 [1.5-6.2]%, BP: -0.4 [-3.4-1.1]%). Among bone formation markers, serum levels of bone alkaline phosphatase were slightly elevated in the ROMO… The authors conclude: Treatment with ROMO significantly increased lumbar spine BMD in glucocorticoid-treated patients, suggesting that ROMO is effective for GIOP. CLINICAL TRIAL NUMBER: UMIN000037239. The clinical value of the result depends on whether the trial population, comparator, follow-up and outcome match the decision in front of the clinician. Can I use this with my patients? The findings can inform..
References
Kawazoe M, Kaneko K, Masuoka S, et al.. Comparison of Efficacy of Romosozumab With Denosumab and Risedronate in Patients Newly Initiating Glucocorticoid Therapy.. J Clin Endocrinol Metab. 2025-Jul-15. doi:10.1210/clinem/dgae810. PMID: 39552045.