The Optimal Long Term Treatment Strategy of Anti-resorptive Medications

NCT ID: NCT05091086

Last Updated: 2025-05-22

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-20
• Study Completion Date: 2030-12-31

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.

Conditions

Osteoporosis; Bone Mineral Density

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Persistent treatment of Denosumab:

persistent denosumab for 7 years

Group Type: ACTIVE_COMPARATOR

Continuous Denosumab

Intervention Type: DRUG

Active comparator: persistent treatment of denosumab.

Alternating treatment of Denosumab and Zoledronic acid

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.

Group Type: EXPERIMENTAL

Administer zoledronate and denosumab on an alternating schedule

Intervention Type: DRUG

In the experimental group, zoledronic acid was administered for one year, followed by two years of denosumab. This cycle was repeated, with the regimen concluding with one year of zoledronic acid.

Interventions

Continuous Denosumab

Active comparator: persistent treatment of denosumab.

Intervention Type: DRUG

Administer zoledronate and denosumab on an alternating schedule

In the experimental group, zoledronic acid was administered for one year, followed by two years of denosumab. This cycle was repeated, with the regimen concluding with one year of zoledronic acid.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

National Taiwan University Clinical Trial Center

National Taiwan University Hospital Yunlin Branch, Orthopedic department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

National Taiwan University Hospital, Yunlin branch

Douliu, Yunlin county, Taiwan

Countries

Taiwan

Other Identifiers

202107164MINC

Identifier Type: -

Identifier Source: org_study_id