Comparing two treatment regimens for osteoporosis in postmenopausal women

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• National Taiwan University Hospital
  Taipei, Taiwan Recruiting

Study contacts

• Study coordinator: Fon-Yih Tsuang
• Email: k880113a@gmail.com
• Phone: 886-2312-3456

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Romosozumab and denosumab alone or together for postmenopausal osteoporosis

  This 6-month pilot tests whether cyclic romosozumab combined with denosumab improves bone density more than denosumab alone in postmenopausal women with osteoporosis.

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• MicroRNA and bone markers linked to response to romosozumab and abaloparatide in postmenopausal osteoporosis

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• Ibandronate vs. Zoledronic Acid After Denosumab: Is Either Equal for Postmenopausal Osteoporosis?

  In postmenopausal osteoporosis, this study tests whether intravenous ibandronate given after stopping denosumab works as well as zoledronic acid over a year.

  Recruiting Phase 4 National Taiwan University Hospital · Taipei · NCT07406685

• Denosumab effects on muscle strength and insulin sensitivity

  This trial will test whether denosumab improves muscle strength and insulin sensitivity in postmenopausal women with osteoporosis and type 2 diabetes who are taking metformin.

  Recruiting Phase 4 Aarhus University Hospital · Aarhus · NCT07271771

• Combining two medications for treating postmenopausal osteoporosis

  This study is testing whether combining two approved medications can help women over 45 with postmenopausal osteoporosis improve their bone health and lower their risk of fractures.

  Recruiting Phase 4 Massachusetts General Hospital · Boston, Massachusetts · NCT06558188

• Evaluating treatments after osteoanabolic therapy for osteoporosis

  This study is testing different follow-up treatments for Caucasian women with severe osteoporosis after they’ve finished a specific therapy to see which one helps improve their bone health the most.

  Recruiting at 8 sites 424 General Military Hospital · Athens and 7 other locations · NCT06164795

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.