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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 50
Maximum Age: 80
Healthy Volunteers: f
View:

• Postmenopausal women over 50 years of age eligible for osteoporosis treatment, defined as having a bone mineral density (BMD) T-score ≤ -2.5 at the lumbar spine, total hip, or femoral neck, and who have never received osteoporosis medications (including both injectable and oral agents); or those who have used oral osteoporosis medications for no more than six months and have discontinued them for at least three months; or those who have previously received injectable osteoporosis drugs but have discontinued them for more than two years.

Locations
Other Locations
Taiwan
National Taiwan University Hospital Yunlin Branch
RECRUITING
Douliu
Contact Information
Primary
Shau-Huai Fu, PhD
b90401045@gmail.com
+886972655734
Time Frame
Start Date: 2025-12-03
Estimated Completion Date: 2026-07-31
Participants
Target number of participants: 90
Treatments
Active_comparator: Denosumab
After study entry, a single dose of denosumab will be administered for a six-month duration.
Active_comparator: Romosozumab
After study entry, romosozumab will be administered monthly for six months.
Experimental: Romosozumab plus denosumab
After study entry, a single dose of denosumab will be administered. Romosozumab will be given monthly for six months.
Sponsors
Leads: National Taiwan University Hospital

This content was sourced from clinicaltrials.gov