NCT06938152RecruitingPhase 4
Effects of Cycle Therapy vs Sequential Therapy With Romosozumab and Denosumab in Postmenopausal Osteoporosis Patients
Effects of Cycle Therapy With Romosozumab and Denosumab 2 Years vs 1 Year Romosozumab Followed by 1 Year Denosumab in Postmenopausal Osteoporosis Patients-A Randomized Control Trial
Source: ClinicalTrials.gov · Last updated 23 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 70 (estimated)
- First submitted
- 6 Apr 2025
- Start date
- 8 Apr 2025
- Primary completion date
- 30 Apr 2029
- Lead sponsor
- National Taiwan University Hospital
- Diseases
- Osteoporosis
- NCT number
- NCT06938152
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 70
- From 8 Apr 2025 to the primary completion date, 30 Apr 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 1\. Previous osteoporosis treatment within the past two years, including Romosozumab, Teriparatide, Denosumab, Alendronate, Ibandronate, Zoledronic Acid, Risedronate, Raloxifene, or Bazedoxifene
- 10\. Planned dental procedures (e.g., extractions, implants) within the next year
Other illness
- 2\. Allergy to Romosozumab or Denosumab
- 4\. Autoimmune disease
- 5\. Chronic steroid use (e.g., Chronic Obstruction Pulmonary Disease patients)
- 7\. Metabolic bone diseases
- 9\. Cancer patients (except for in situ carcinoma and non-melanoma skin cancer, unless fully treated and in remission for five years)
- 11\. History of stent placement, myocardial infarction, stroke, or coronary artery disease
Lab values
- 12\. Renal disease (Creatinine \> 1.5 mg/dL) or dialysis patients
Other
- 3\. Secondary osteoporosis
- 6\. Hypercalcemia or hypocalcemia
- 8\. Primary or metastatic bone tumors
- 13\. Smoking more than one pack per day (except for those who have quit for over ten years)
Who the study is looking for
- 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
Age in the registry: 50 years to 90 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| National Taiwan University Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.