The Optimal Long Term Treatment Strategy of Anti-resorptive Medications

Phase 4Active Not RecruitingNCT05091086

National Taiwan University Hospital60 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Osteoporosis Bone Mineral Density

Interventions

Continuous DenosumabDRUG

Active comparator: persistent treatment of denosumab.

Administer zoledronate and denosumab on an alternating scheduleDRUG

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.

Eligibility

Sex: ALLMin age: 50 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

National Taiwan University Hospital, Yunlin branch

Douliu, Yunlin county, Taiwan

Outcomes

Primary Outcomes

Change in lumbar spine bone mineral density

Time frame: From enrollment to the end of treatment at 3 years