Zoledronic Acid to Maintain Bone Mass After Denosumab Discontinuation (AfterDmab)

March 8, 2019 updated by: Athanasios D. Anastasilakis, 424 General Military Hospital

The Effect of Zoledronic Acid Infusion in the Bone Loss Observed Following Denosumab Discontinuation in Postmenopausal Women With Low Bone Mass

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Discontinuation of denosumab results in a rebound rise of bone turnover markers and gradual loss of the achieved bone mineral density gains. In contrast, bisphosphonates, such as zoledronic acid, remain within the skeleton acting for several months or even years after discontinuation while maintaining bone mineral density despite the cessation of treatment. In this study, the investigators aim to evaluate changes in bone mineral density of the lumbar spine and the femoral neck, as well as in bone turnover markers one year after treatment discontinuation both in denosumab-treated women and in denosumab-treated women who switched to zoledronic acid infusion one year before treatment discontinuation.

Study Type

Interventional

Enrollment (Actual)

57

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Athens, Greece, 11525
        • 251 Airforce & VA General Hospital
      • Thessaloniki, Greece, 56429
        • 424 General Military Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • postmenopausal women
  • osteopenic (T-score > -2.5 but < -1.0) after treatment with denosumab

Exclusion Criteria:

  • secondary osteoporosis;
  • diseases that could affect bone metabolism;
  • medications that could affect bone metabolism;
  • history of any antiosteoporotic treatment other than denosumab prior to randomization
  • severe liver or kidney disease (creatinine clearance < 60ml/min/1.73m2)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Denosumab
Patients with low bone mass, being treated only with denosumab in the past, who will receive another year of treatment with denosumab and subsequently discontinue treatment for one year
Drug: Denosumab
Treatment of low bone mass with subcutaneous injections of denosumab 60 mg every 6 months for one year
Other Names:
  • Prolia
Experimental: Denosumab plus zoledronic acid
Patients with low bone mass, being treated only with denosumab in the past, who will receive a single infusion of zoledronic acid and subsequently discontinue treatment for another year
Drug: Zoledronic acid
Treatment of low bone mass with a single infusion of zoledronic acid 5 mg for one year
Other Names:
  • Aclasta

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
bone mineral density of the lumbar spine
Time Frame: from 12 to 24 months
differences between the 2 arms in the changes of lumbar spine bone mineral density measured by dual-energy X-ray absorptiometry
from 12 to 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
bone mineral density of the femoral neck
Time Frame: from 12 to 24 months
differences between the 2 arms in the changes of femoral neck bone mineral density measured by dual-energy X-ray absorptiometry
from 12 to 24 months
C-terminal telopeptide of type I collagen
Time Frame: from 12 to 15, 18, 24 months
differences between the 2 arms in the changes of C-terminal telopeptide of type I collagen
from 12 to 15, 18, 24 months
propeptide of procollagen type I
Time Frame: from 12 to 15, 18, 24 months
differences between the 2 arms in the changes of propeptide of procollagen type I
from 12 to 15, 18, 24 months
bone mineral density of the lumbar spine
Time Frame: from baseline to 12 months
differences between the 2 arms in the changes of lumbar spine bone mineral density measured by dual-energy X-ray absorptiometry
from baseline to 12 months
bone mineral density of the femoral neck
Time Frame: from baseline to 12 months
differences between the 2 arms in the changes of femoral neck bone mineral density measured by dual-energy X-ray absorptiometry
from baseline to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

424 General Military Hospital

Collaborators

Leiden University Medical Center
251 Hellenic Air Force & VA General Hospital

Investigators

  • Principal Investigator: Athanasios D Anastasilakis, PhD, 424 General Military Hospital, Thessaloniki, Greece
  • Principal Investigator: Polyzois Makras, PhD, 251 Airforce and VA General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2015

Primary Completion (Actual)

November 1, 2018

Study Completion (Actual)

November 26, 2018

Study Registration Dates

First Submitted

July 14, 2015

First Submitted That Met QC Criteria

July 14, 2015

First Posted (Estimate)

July 16, 2015

Study Record Updates

Last Update Posted (Actual)

March 11, 2019

Last Update Submitted That Met QC Criteria

March 8, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AfterDmab

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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