Single or Repeat Zoledronate Versus Alendronate Following Denosumab (EUROpean Denosumab Effects Consolidation Study) (EURODEC)

November 29, 2023 updated by: Athanasios D. Anastasilakis, 424 General Military Hospital

The Effectiveness of Single or Repeat Zoledronate Infusion Versus Oral Alendronate in Consolidating the Bone Accrual Achieved With Denosumab: a Study Organised by the European Calcified Tissue Society

A 24-month prospective, open-label, randomized, multicenter, multinational, non-inferiority pragmatic clinical trial evaluating zoledronate single or double infusion versus oral alendronate following denosumab

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

125 postmenopausal women treated with Dmab for 3 or more years who will reach osteopenia with denosumab will be randomized into three groups: i) zoledronate infusion (5mg) at 6 months after last Dmab dose (single Zol group) ii) zoledronate infusion (5mg) at 6 and 12 months after last Dmab dose (double Zol group) iii) alendronate 70mg orally weekly for 12 months (ALN group) All women will receive no further treatment during the 2nd year of the study.

Participating centers: ECTS affiliated bone centers

Endpoints: Primary: BMD changes at the lumbar spine at 12 months. Secondary: i) BMD changes at the lumbar spine at 24 months; ii) BMD changes at the non-dominant femoral neck and total hip at 12 and 24 months; iii) changes at levels of bone turnover markers throughout the study; iv) incident fractures: vertebral (clinical and morphometric identified on VFA scans) and non-vertebral; v) clinical parameters: height change, VAS for back pain, and use of analgesics

Study Type

Observational

Enrollment (Estimated)

125

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

  • France
  • Germany
      • Dresden, Germany
  • Greece
      • Athens, Greece, 11525
        • Recruiting
        • 251 Hellenic Airforce and VA General Hospital
        • Contact:
      • Athens, Greece, 11527
        • Recruiting
        • First Department of Propaedeutic and Internal Medicine, Medical School, National and Kapodistrian University of Athens
        • Contact:
      • Athens, Greece, 14561
        • Not yet recruiting
        • , KAT General Hospital
        • Contact:
      • Thessaloniki, Greece, 56429
        • Recruiting
        • 424 General Military Hospital
        • Contact:
        • Contact:
  • Italy
      • Milan, Italy
        • Not yet recruiting
        • Fondazione IRCCS Cà Granda-Ospedale Maggiore Policlinico
        • Contact:
        • Sub-Investigator:
          • Giorgia Grassi, MD
      • Roma, Italy, 00128
        • Not yet recruiting
        • Campus Bio-Medico University
        • Contact:
        • Contact:
          • Gaia Tabacco, PhD
        • Sub-Investigator:
          • Anda Naciu, PhD
        • Sub-Investigator:
          • Gaia Tabacco, PhD
      • Siena, Italy, 53100
        • Not yet recruiting
        • Department of Medicine, Surgery and Neurosciences, University of Siena
        • Contact:
        • Contact:
          • Daniela Merlotti
        • Sub-Investigator:
          • Daniela Merlotti
      • Udine, Italy
        • Not yet recruiting
        • University-Hospital S. Maria della Misericordia
        • Contact:
        • Sub-Investigator:
          • Antonio Salcuni

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 to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Postmenopausal women treated with denosumab

Description

Inclusion Criteria:

• Postmenopausal women treated with denosumab for 3 or more years who will reach osteopenia

Exclusion Criteria:

  • a bone disease other than postmenopausal osteoporosis
  • use of medications other than bisphosphonates or SERMS affecting bone metabolism during the last 12 months before entering the study
  • creatinine clearance <60 mL/min/1.73 m2
  • liver failure
  • any type of cancer
  • uncontrolled endocrine diseases
  • serum 25-hydroxy vitamin D (25-OHD) concentrations lower than 20 ng/mL (50 nmol/L)

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
single Zol group
postmenopausal women treated with denosumab for 3 or more years who will reach osteopenia with denosumab and will receive a single zoledronate infusion (5mg) at 6 months after the last denosumab dose
Drug: Zoledronate or Alendronate
infusion (for zoledronate) or oral digestion (for alendronate)
Other Names:
  • Calcium and vitamin D supplementation
double Zol group
postmenopausal women treated with denosumab for 3 or more years who will reach osteopenia with denosumab and will receive two zoledronate infusions (5mg) at 6 and 12 months after the last denosumab dose
Drug: Zoledronate or Alendronate
infusion (for zoledronate) or oral digestion (for alendronate)
Other Names:
  • Calcium and vitamin D supplementation
ALN group
postmenopausal women treated with denosumab for 3 or more years who will reach osteopenia with denosumab and will receive alendronate 70mg orally weekly for 12 months
Drug: Zoledronate or Alendronate
infusion (for zoledronate) or oral digestion (for alendronate)
Other Names:
  • Calcium and vitamin D supplementation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
lumbar spine BMD
Time Frame: 24 months
BMD changes at the lumbar spine at 12 and 24 months
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
femoral neck BMD
Time Frame: 24 months
BMD changes at the non-dominant femoral neck and total hip at 12 and 24 months
24 months
P1NP
Time Frame: baseline, 3 months, 6 months, 12 months, 18 months, 24 months
bone turnover (formation) marker
baseline, 3 months, 6 months, 12 months, 18 months, 24 months
CTx
Time Frame: 24 months
bone turnover (resorption) marker
24 months
fracture
Time Frame: 24 months
incident fractures: vertebral (clinical and morphometric identified on VFA scans) and non-vertebral
24 months
height
Time Frame: 24 months
loss of height
24 months

Collaborators and Investigators

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

Sponsor

424 General Military Hospital

Investigators

  • Principal Investigator: Willem Lems, Prof, ECTS Clinical Action Group

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)

November 28, 2023

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 1, 2026

Study Registration Dates

First Submitted

October 7, 2022

First Submitted That Met QC Criteria

October 8, 2022

First Posted (Actual)

October 12, 2022

Study Record Updates

Last Update Posted (Estimated)

December 5, 2023

Last Update Submitted That Met QC Criteria

November 29, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EURODEC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Clinical Trials on Osteoporosis, Postmenopausal

Clinical Trials on Zoledronate or Alendronate

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Greece

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe