A Phase 4 interventional study of Denosumab and Romosozumab in Osteoporosis, sponsored by National Taiwan University Hospital. Recruiting at 1 site in Taiwan. Open to female participants aged 50 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-12-16.
Sponsored by National Taiwan University Hospital · Phase 4, Interventional, and Treatment
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.
1,640 studies on the registry are indexed under Osteoporosis; 212 are open to participants now.
This study's planned enrollment of 90 is close to the median of 95 across 1,133 interventional studies indexed under Osteoporosis.
Browse Osteoporosis studies →National Taiwan University Hospital is the lead sponsor of 2,563 studies on the registry; 569 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
After study entry, a single dose of denosumab will be administered for a six-month duration.
Drug: Denosumab
After study entry, romosozumab will be administered monthly for six months.
Drug: Romosozumab
After study entry, a single dose of denosumab will be administered. Romosozumab will be given monthly for six months.
Drug: Denosumab · Drug: Romosozumab
After study entry, a single dose of denosumab will be administered for a six-month duration.
After study entry, romosozumab will be administered monthly for six months.
6-Month Percentage Change in PA Spine BMD
Percentage change from baseline in PA spine BMD at 6 months
Time frame: 6 months
6-Month Percentage Change in femoral neck BMD
Percentage change from baseline in femoral neck BMD at 6 months
Time frame: 6 months
6-Month Percentage Change in total hip BMD
Percentage change from baseline in total hip BMD at 6 months
Time frame: 6 months
Percentage Change in Serum CTX at 6 Months
Six-month percentage change in CTX from baseline.
Time frame: 6 months
Percentage Change in Serum P1NP at 6 Months
Six-month percentage change in P1NP from baseline.
Time frame: 6 months
Changes in Bone Metabolism Markers
Changes in OPG, RANKL, and Osteocalcin
Time frame: 6 months
Radiographic Changes at Hip and Spine
X-ray Changes in Hip, Spine, and Pelvis
Time frame: 6 months
Incidence of Clinical Osteoporotic Fractures
Clinical Osteoporotic Fracture Rate
Time frame: 6 months
Change in Quality of Life
Change in Quality of Life, measured by EQ5D5L
Time frame: 6 months
Safety Outcome: Adverse Events
any Adverse Events
Time frame: 6 months
Plan to share: No
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National Taiwan University Hospital