Denosumab Sequential Therapy

• Status: Recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Denosumab is a potent anti-resorptive agent and is now widely used in the treatment of osteoporosis. Although denosumab has excellent effect to increase bone mass and prevent fracture in FREEDOM study with very low complications, even up to ten years, it's effect is reversible. After holding the drug, circulating denosumab levels fall rapidly, and bone resorption reaching twice baseline levels for about 6 months. How to prevent bone loss after denosumab therapy is an important issue, especially when considering the compliance, persistence, or other comorbidities of the patient. We want to verify if zoledronic acid could be used as a sequential therapy after denosumab to prevent rapid bone loss by randomized clinical trial.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Taiwan University Hospital
• Treatments: Denosumab; Zoledronic Acid

Criteria

Inclusion Criteria:

1. Postmenopausal women

2. Men >50-year-old

3. After Denosumab treatment ≥ 2 years due to osteoporosis

Exclusion Criteria:

1. secondary osteoporosis

2. metabolic bone disease

3. cancer history

4. continuous steroid therapy

5. hormone replacement therapy

6. ever used any other kind of anti-resorptive treatment

6.estimated Glomerular filtration rate< 35 mL/min 7.allergy to Zoledronic acid 8.hypocalcaemia 9.any contraindications to use Zoledronic acid