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

National Taiwan University

Status and phase: Enrolling; Phase 4

Conditions: Osteoporosis; Osteoporosis Postmenopausal

Treatments: Drug: Romosozumab followed by Denosumab; Drug: Romosozumab and Denosumab Cycle Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06938152

202501144MINE

Details and patient eligibility

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.

Full description

Osteoporosis is common in postmenopausal women and the elderly, and has been recognized by the World Health Organization as the second most prevalent metabolic bone disease worldwide. Most patients show no obvious symptoms, but a fall or sudden exertion can cause fragility fractures. Once fractures occur, complications such as acute pain, prolonged bed rest, and restricted mobility can significantly impact the quality of life and even increase mortality. Furthermore, managing these conditions requires substantial medical and social resources.

Currently, anti-osteoporosis medications are classified into two major categories: antiresorptive and anabolic agents. Studies have confirmed that both types can increase bone mineral density (BMD) and reduce fracture risk. However, each medication has usage limitations.

Denosumab is a potent antiresorptive drug, but long-term use can lead to rare side effects such as atypical femoral fractures (AFF) and medication-related osteonecrosis of the jaw (MRONJ). Additionally, stopping Denosumab can cause a severe rebound in bone resorption markers (CTX), leading to rapid BMD loss and an increased fracture risk. Managing drug discontinuation remains a major clinical challenge.

Enrollment: 70 estimated patients

Sex: Female

Ages: 50 to 90 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

Sequential therapy group

Active Comparator group

Description:

Romosozumab followed by Denosumab

Treatment:

Drug: Romosozumab followed by Denosumab

Cycle therapy group

Experimental group

Description:

Romosozumab and Denosumab Cycle Therapy

Treatment:

Drug: Romosozumab and Denosumab Cycle Therapy