Romosozumab and denosumab alone or together for postmenopausal osteoporosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• National Taiwan University Hospital Yunlin Branch
  Douliu, Taiwan, Taiwan Recruiting

Study contacts

• Study coordinator: Shau-Huai Fu, PhD
• Email: b90401045@gmail.com
• Phone: +886972655734

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.