Actively Recruiting

Phase 4
Age: 50Years - 90Years
FEMALE
NCT06938152

Effects of Cycle Therapy vs Sequential Therapy With Romosozumab and Denosumab in Postmenopausal Osteoporosis Patients

Led by National Taiwan University Hospital · Updated on 2025-12-19

70

Participants Needed

1

Research Sites

246 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Effects of Cycle Therapy vs Sequential Therapy With Romosozumab and Denosumab in Postmenopausal Osteoporosis Patients

Who Can Participate

Age: 50Years - 90Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Postmenopausal women aged 50 to 90 years
  • Bone mineral density T-score 3.0 at any lumbar vertebra
  • Physically and mentally able to understand and follow study procedures
  • Signed informed consent
Not Eligible

You will not qualify if you...

  • Previous osteoporosis treatments in the last two years including Romosozumab, Teriparatide, Denosumab, and bisphosphonates
  • Allergy to Romosozumab or Denosumab
  • Secondary osteoporosis
  • Autoimmune diseases
  • Chronic steroid use (e.g., COPD patients)
  • High or low calcium levels
  • Other metabolic bone diseases
  • Primary or metastatic bone tumors
  • Active cancer except treated in situ carcinoma or non-melanoma skin cancer in remission for five years
  • Planned dental procedures within the next year
  • History of stent placement, heart attack, stroke, or coronary artery disease
  • Kidney disease with creatinine > 1.5 mg/dL or on dialysis
  • Smoking more than one pack per day (except those who quit over ten years ago)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

National Taiwan University Hospital

Taipei, Taiwan

Actively Recruiting

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Research Team

F

Fon-Yih Tsuang

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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