Effects of Cycle Therapy vs Sequential Therapy With Romosozumab and Denosumab in Postmenopausal Osteoporosis Patients

Launched by NATIONAL TAIWAN UNIVERSITY HOSPITAL · Apr 20, 2025

Keywords

ClinConnect Summary

This clinical trial is studying two different treatment approaches for postmenopausal women with osteoporosis, a condition that weakens bones and makes them more likely to break. The trial compares a cyclic therapy, where participants will take Romosozumab for 6 months followed by Denosumab for another 6 months, repeated over two years, against a traditional method where they take Romosozumab for 12 months followed by Denosumab for another 12 months. The goal is to see which method works better in improving bone health.

To participate in this trial, women aged 50 to 90 who have been diagnosed with osteoporosis and have a specific bone density measurement (a T-score of less than -3.0) may be eligible. Participants should not have received specific osteoporosis treatments in the past two years, should not have certain health conditions, and must be able to understand and follow the study's guidelines. Those who join the study can expect regular check-ups and assessments over the two years to track their bone health and overall well-being. This trial is currently recruiting participants, so if you or someone you know might be interested, it could be a great opportunity to help advance osteoporosis treatment.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Postmenopausal women aged 50-90 years
• • 2. BMD T-score ≤ -3.0 at any lumbar vertebra
• • 3. Physically and mentally capable of understanding and complying with the study protocol and follow-up
• • 4. Signed informed consent
• Exclusion Criteria:
• • 1. Previous osteoporosis treatment within the past two years, including Romosozumab, Teriparatide, Denosumab, Alendronate, Ibandronate, Zoledronic Acid, Risedronate, Raloxifene, or Bazedoxifene
• • 2. Allergy to Romosozumab or Denosumab
• • 3. Secondary osteoporosis
• • 4. Autoimmune disease
• • 5. Chronic steroid use (e.g., Chronic Obstruction Pulmonary Disease patients)
• • 6. Hypercalcemia or hypocalcemia
• • 7. Metabolic bone diseases
• • 8. Primary or metastatic bone tumors
• • 9. Cancer patients (except for in situ carcinoma and non-melanoma skin cancer, unless fully treated and in remission for five years)
• • 10. Planned dental procedures (e.g., extractions, implants) within the next year
• • 11. History of stent placement, myocardial infarction, stroke, or coronary artery disease
• • 12. Renal disease (Creatinine \> 1.5 mg/dL) or dialysis patients
• • 13. Smoking more than one pack per day (except for those who have quit for over ten years)