NCT06938152 Effects of Cycle Therapy vs Sequential Therapy With Romosozumab and Denosumab in Postmenopausal Osteoporosis Patients
| NCT ID | NCT06938152 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | National Taiwan University Hospital |
| Condition | Osteoporosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 70 participants |
| Start Date | 2025-04-08 |
| Primary Completion | 2029-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 70 participants in total. It began in 2025-04-08 with a primary completion date of 2029-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study is a prospective, randomized, controlled clinical trial comparing the efficacy of a 24-month cyclic therapy regimen (6 months of Romosozumab followed by 6 months of Denosumab, repeated for two years) versus a traditional sequential treatment regimen (12 months of Romosozumab followed by 12 months of Denosumab). The goal is to determine which approach yields better therapeutic outcomes and to optimize drug strategies for osteoporosis patients.
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)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06938152 clinical trial?
This trial is open to female participants only, aged 50 Years or older, up to 90 Years, studying Osteoporosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06938152 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06938152 currently recruiting?
Yes, NCT06938152 is actively recruiting participants. Contact the research team at k880113a@gmail.com for enrollment information.
Where is the NCT06938152 trial being conducted?
This trial is being conducted at Taipei, Taiwan.
Who is sponsoring the NCT06938152 clinical trial?
NCT06938152 is sponsored by National Taiwan University Hospital. The trial plans to enroll 70 participants.