Romosozumab and denosumab alone or together for postmenopausal osteoporosis
Romosozumab and Denosumab, Alone or Combined, in Postmenopausal Osteoporosis: A Three-Arm Randomized Pilot Trial
This 6-month pilot tests whether cyclic romosozumab combined with denosumab improves bone density more than denosumab alone in postmenopausal women with osteoporosis.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 50 Years to 80 Years |
| Sex | Female |
| Sponsor | National Taiwan University Hospital Academic / other |
| Drugs / interventions | denosumab, romosozumab |
| Locations | 1 site (Douliu, Taiwan) |
| Trial ID | NCT07283887 on ClinicalTrials.gov |
What this trial studies
This single-center, open-label, randomized pilot will enroll 90 postmenopausal women with osteoporosis (T-score ≤ -2.5) at NTUH Yunlin Branch and compare cyclic romosozumab plus denosumab against standard denosumab monotherapy over six months. Outcomes include changes in bone mineral density and biochemical bone turnover markers. The trial also incorporates X-ray feature extraction and AI-based radiomic analysis to explore imaging biomarkers that might guide precision therapy. Eligible participants are treatment-naïve or have minimal prior exposure to osteoporosis medications and must meet standard safety exclusions.
Who should consider this trial
Good fit: Postmenopausal women over 50 with osteoporosis (T-score ≤ -2.5) who meet the protocol washout and safety criteria are the intended participants.
Not a fit: Patients older than 80, those with secondary metabolic bone disease, ongoing contraindicated medications or active cancer, or those with contraindications to romosozumab or denosumab (for example recent myocardial infarction) are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the combined cyclic approach could raise bone density faster and help more patients reach safer T-scores than denosumab alone.
How similar studies have performed: Romosozumab and denosumab each increase BMD in prior trials and sequential anabolic→antiresorptive approaches have shown benefit, but cyclic combination therapy with integrated AI radiomics is largely novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * Age \>80 years; continuous corticosteroid use; secondary osteoporosis; current use of medications affecting bone metabolism; ongoing hormone replacement therapy; metabolic bone disorders; active cancer; hypocalcemia; continued use of any osteoporosis treatment without an adequate washout period; contraindications to denosumab; and contraindications to romosozumab, such as a history of myocardial infarction or stroke within the past year.
Where this trial is running
Douliu, Taiwan
- National Taiwan University Hospital Yunlin Branch — Douliu, Taiwan, Taiwan (Recruiting)
Study contacts
- Study coordinator: Shau-Huai Fu, PhD
- Email: b90401045@gmail.com
- Phone: +886972655734
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.