Comparing two treatment regimens for osteoporosis in postmenopausal women

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

This study is testing two different treatment plans for osteoporosis in postmenopausal women to see which one helps improve bone strength and reduce the risk of fractures better.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 70 (estimated)
• Ages: 50 Years to 90 Years
• Sex: Female
• Sponsor: National Taiwan University Hospital (other)
• Drugs / interventions: Romosozumab, Denosumab
• Locations: 1 site (Taipei)
• Trial ID: NCT06938152 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of a 24-month cyclic therapy regimen using Romosozumab followed by Denosumab against a traditional sequential treatment regimen of 12 months each of Romosozumab and Denosumab. The study aims to optimize treatment strategies for postmenopausal women suffering from osteoporosis by assessing improvements in bone mineral density and fracture risk. Participants will be randomly assigned to one of the two treatment groups and monitored over the course of the study to determine which regimen yields better therapeutic outcomes.

Who should consider this trial

Good fit: Ideal candidates for this study are postmenopausal women aged 50-90 years with a bone mineral density T-score of less than -3.0.

Not a fit: Patients with a history of certain medical conditions, recent osteoporosis treatments, or allergies to the study medications may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment strategies that enhance bone health and reduce fracture risk in postmenopausal women with osteoporosis.

How similar studies have performed: While there have been studies on the individual effects of Romosozumab and Denosumab, this specific cyclic therapy approach is novel and has not been extensively tested.

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)

Where this trial is running

Taipei

• National Taiwan University Hospital — Taipei, Taiwan (RECRUITING)

Study contacts

• Study coordinator: Fon-Yih Tsuang

Conditions: Osteoporosis, Osteoporosis Postmenopausal, postmenopausal, Romosozumab, Denosumab, cycle therapy, Bone mineral density, Bone turnover marker