The Optimal Long Term Treatment Strategy of Anti-resorptive Medications

Phase 4

Active, not recruiting

• Conditions: Osteoporosis; Bone Mineral Density
• Interventions: Drug: Continuous Denosumab; Drug: Administer zoledronate and denosumab on an alternating schedule

• Registration Number: NCT05091086
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

This study is to investigate whether the alternating use of Prolia (Denosumab) and Aclasta (Zoledronic acid) can continue to increase bone density.

Detailed Description

This study intends to use a randomized trial to test whether the long-term treatment of Denosumab and Zoledronic acid can achieve sustained bone density progress and avoid the risk of rapid bone loss after the withdrawal of Denosumab.

Study Timeline

• Study First Submitted: 2021-10-11
• Study First Submitted QC: 2021-10-22
• Study First Posted: 2021-10-25
• Study Start: 2021-11-20
• Status Verified: 2025-01
• Last Update Submitted: 2025-05-20
• Last Update Posted: 2025-05-22
• Primary Completion: 2025-12-31
• Study Completion: 2030-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Postmenopausal women or men over 50 years old with osteoporosis or osteopenia leading to fractures.
2. Denosumab treatment for at least two years and less than three years (up to maximum of five doses).

Exclusion Criteria

1. Secondary osteoporosis.
2. Metabolic bone diseases.
3. Malignancy.
4. Continuous steroid treatment, hormone therapy or other medical treatment affecting bone metabolism.
5. Patients had ever used antiosteoporosis medications other than Dmab
6. Estimated glomerular filtration rate < 35 mL/min.
7. Allergy to Zoledronate.
8. Any other contraindications to Zoledronate use.
9. History of diagnosed hypocalcemia.
10. Age greater than 80 years.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Persistent treatment of Denosumab:	Continuous Denosumab	persistent denosumab for 7 years
Alternating treatment of Denosumab and Zoledronic acid	Administer zoledronate and denosumab on an alternating schedule	Alternating treatment with denosumab and zoledronic acid over a 7-year period: after entering the trial, patients received one year of zoledronic acid, followed by two years of denosumab, then switched back to zoledronic acid for one year, followed by another two years of denosumab, and finally received one more year of zoledronic acid.

Primary Outcome Measures

Name	Time	Method
Change in lumbar spine bone mineral density	From enrollment to the end of treatment at 3 years

Secondary Outcome Measures

Name	Time	Method
Change in Procollagen type 1 N-terminal propeptide	From enrollment to the end of treatment at 3 years and 7 years
Fractures	3 & 7 years	Number of Participants with clinical fractures and radiographic vertebral fractures
Change in quality of life	From enrollment to the end of treatment at 3 years and 7 years
Change in total hip bone mineral density	From enrollment to the end of treatment at 3 years and 7 years
Change in femoral neck bone mineral density	From enrollment to the end of treatment at 3 years and 7 years
Change in lumbar spine bone mineral density	From enrollment to the end of treatment at 7 years
Change in C-terminal telopeptide of type 1 collagen	From enrollment to the end of treatment at 3 years and 7 years

Trial Locations

Locations (1)

National Taiwan University Hospital, Yunlin branch; 🇨🇳 Douliu, Yunlin county, Taiwan