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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age50-90
SponsorNational Taiwan University Hospital

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Romosozumab followed by Denosumab
  • Romosozumab and Denosumab Cycle Therapy

Treatment groups

70 Participants
are divided into 2 treatment groups