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Compares treatment options for Osteoporosis
Official title Effects of Cycle Therapy vs Sequential Therapy With Romosozumab and Denosumab in Postmenopausal Osteoporosis Patients
ClinicalTrials.gov ID: NCT06938152
What this study is testing
What is Romosozumab followed by Denosumab?
Romosozumab followed by Denosumab is an investigational medicine, being studied as a potential treatment for osteoporosis.
Also referred to as Sequential therapy group.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 to 90, women only
You may be able to join if
- 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
You likely can't join if
- 1\. Previous osteoporosis treatment within the past two years, including Romosozumab, Teriparatide, Denosumab, Alendronate, Ibandronate, Zoledronic...
- 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
See the full eligibility 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
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Taipei, Taiwan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 50 years to 90 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Taipei, Taiwan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.