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

Last updated: November 29, 2023
Sponsor: 424 General Military Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Osteoporosis

Treatment

Zoledronate or Alendronate

Clinical Study ID

NCT05575167
EURODEC
  • Ages 50-85
  • Female

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

  • a bone disease other than postmenopausal osteoporosis
  • use of medications other than bisphosphonates or SERMS affecting bone metabolismduring 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 Design

Total Participants: 125
Treatment Group(s): 1
Primary Treatment: Zoledronate or Alendronate
Phase:
Study Start date:
November 28, 2023
Estimated Completion Date:
November 30, 2026

Study 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

Connect with a study center

  • Univ. Lille, CHU Lille

    Lille,
    France

    Site Not Available

  • Department of Medicine III and Center for Healthy Aging, Technische Universität Dresden

    Dresden,
    Germany

    Site Not Available

  • , KAT General Hospital

    Athens, 14561
    Greece

    Site Not Available

  • 251 Hellenic Airforce and VA General Hospital

    Athens, 11525
    Greece

    Active - Recruiting

  • First Department of Propaedeutic and Internal Medicine, Medical School, National and Kapodistrian University of Athens

    Athens, 11527
    Greece

    Active - Recruiting

  • 424 General Military Hospital

    Thessaloniki, 56429
    Greece

    Active - Recruiting

  • Fondazione IRCCS Cà Granda-Ospedale Maggiore Policlinico

    Milan,
    Italy

    Site Not Available

  • Campus Bio-Medico University

    Roma, 00128
    Italy

    Site Not Available

  • Department of Medicine, Surgery and Neurosciences, University of Siena

    Siena, 53100
    Italy

    Site Not Available

  • University-Hospital S. Maria della Misericordia

    Udine,
    Italy

    Site Not Available

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