NCT07283887

Romosozumab and Denosumab, Alone or Combined, in Postmenopausal Osteoporosis

Romosozumab and Denosumab, Alone or Combined, in Postmenopausal Osteoporosis: A Three-Arm Randomized Pilot Trial

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: National Taiwan University Hospital · Academic / Other
• Sex: Female
• Age: 50 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Osteoporosis is a lifelong chronic condition requiring long-term management. Conventional first-line anti-resorptive therapies often yield slow BMD improvement and may plateau after years of treatment. Recent AACE/ACE guidelines recommend anabolic agents as initial therapy in patients with severe osteoporosis or very high fracture risk; however, even anabolic monotherapy may be insufficient, with many patients failing to reach a T-score ≥ -2.5. To address this unmet need, we propose a pilot study exploring cyclic treatment using romosozumab combined with denosumab, compared with standard denosumab monotherapy. In addition to monitoring biochemical bone markers and BMD, we will incorporate imaging feature extraction from X-rays and AI-based radiomic analysis to identify imaging biomarkers that may support precision treatment strategies. This single-center, open-label, 6-month, randomized pilot trial will enroll 90 postmenopausal women with osteoporosis (T-score ≤ -2.5) at NTUH Yunlin Branch, randomized 1:1:1 into three arms: denosumab alone, romosozumab alone, or combined therapy. The primary endpoint is percent change in lumbar spine BMD at 6 months; secondary outcomes include hip and femoral neck BMD, bone turnover markers (CTX, P1NP), fracture incidence, and adverse events. Results will estimate effect size and synergy to inform future large-scale RCTs and clinical application.

Conditions

• Osteoporosis

Interventions

Type	Name	Description
DRUG	Denosumab	After study entry, a single dose of denosumab will be administered for a six-month duration.
DRUG	Romosozumab	After study entry, romosozumab will be administered monthly for six months.

Timeline

• Start date: 2025-12-03
• Primary completion: 2026-07-31
• Completion: 2026-07-31
• First posted: 2025-12-16
• Last updated: 2025-12-16

Locations

1 site across 1 country: Taiwan

Regulatory

• FDA-regulated drug study