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Zoledronic Acid to Maintain Bone Mass After Denosumab Discontinuation

NCT02499237 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 57

Last updated 2019-03-11

No results posted yet for this study

Summary

In contrast with bisphosphonates,discontinuation of denosumab results in gradual loss of bone mineral density gains. The investigators aim to evaluate whether in patients treated with denosumab, a single zoledronic acid infusion would prevent the anticipated bone loss.

Conditions

  • Postmenopausal Osteoporosis

Interventions

DRUG

Denosumab

Treatment of low bone mass with subcutaneous injections of denosumab 60 mg every 6 months for one year

DRUG

Zoledronic acid

Treatment of low bone mass with a single infusion of zoledronic acid 5 mg for one year

Sponsors & Collaborators

  • 251 Hellenic Air Force & VA General Hospital

    collaborator OTHER

  • Leiden University Medical Center

    collaborator OTHER

  • 424 General Military Hospital

    lead OTHER

Principal Investigators

  • Athanasios D Anastasilakis, PhD · 424 General Military Hospital, Thessaloniki, Greece

  • Polyzois Makras, PhD · 251 Airforce and VA General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-31
Primary Completion
2018-11-30
Completion
2018-11-26

Countries

  • Greece

Study Locations

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Entities

Drugs

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 NCT02499237 on ClinicalTrials.gov