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Denosumab Sequential Therapy

NCT03868033 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 101

Last updated 2024-04-23

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Zoledronic Acid

Use Zoledronic acid as a sequential therapy after denosumab treatment for more than 2 years

DRUG

Denosumab

Continuous Denosumab treatment in arm 1 for two years or as a 2nd year treatment in arm 2 for one year

Sponsors & Collaborators

  • National Taiwan University Hospital

    lead OTHER

Principal Investigators

  • Shau-Huai Fu, doctor · Department of Orthopedics, National Taiwan University Hospital Yunlin Branch

  • Chia-Che Lee · Department of Orthopedics, National Taiwan University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-12
Primary Completion
2023-07-01
Completion
2023-12-31
FDA Drug
Yes

Countries

  • Taiwan

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03868033 on ClinicalTrials.gov