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Treatment With Zoledronic Acid Subsequent to Denosumab in Osteoporosis

NCT03087851 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2021-02-21

Study results available
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Summary

Denosumab is an antibody against receptor-activator of nuclear factor kappa-B ligand that prevents recruitment and differentiation of mature osteoclasts. Treatment markedly decrease bone resorption and fracture risk, and many patients will reach osteopenic bone mineral density (BMD) levels on treatment with denosumab. The treatment effect on bone turnover and BMD has, however, been demonstrated to be reversible. This study will show if the bone mass can be maintained by administrating zoledronic acid and if timing of the first dose of zoledronic acid after last dose of denosumab matters.

Conditions

Interventions

DRUG

Zoledronic Acid

Intravenous infusion of 5 mg zoledronic acid

Sponsors & Collaborators

  • University of Aarhus

    collaborator OTHER

  • Amgen

    collaborator INDUSTRY

  • Aarhus University Hospital

    lead OTHER

Principal Investigators

  • Bente L Langdahl, MD PhD DMSc · Department of Endocrinology and Internal Medicine, Aarhus University Hospital, Denmark

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-13
Primary Completion
2020-08-01
Completion
2020-08-01
FDA Drug
Yes

Countries

  • Denmark

Study Locations

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Diseases
Companies

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 NCT03087851 on ClinicalTrials.gov