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

Sponsor
424 General Military Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05575167
Collaborator
(none)
125
Enrollment
1
Location
28.1
Anticipated Duration (Months)
4.5
Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease Intervention/Treatment Phase
  • Drug: Zoledronate or Alendronate

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 Design

Study Type:
Observational
Anticipated Enrollment :
125 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
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
Anticipated Study Start Date :
May 1, 2023
Anticipated Primary Completion Date :
Jun 1, 2025
Anticipated Study Completion Date :
Sep 1, 2025

Arms and Interventions

Arm 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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. lumbar spine BMD [24 months]

      BMD changes at the lumbar spine at 12 and 24 months

    Secondary Outcome Measures

    1. femoral neck BMD [24 months]

      BMD changes at the non-dominant femoral neck and total hip at 12 and 24 months

    2. P1NP [baseline, 3 months, 6 months, 12 months, 18 months, 24 months]

      bone turnover (formation) marker

    3. CTx [24 months]

      bone turnover (resorption) marker

    4. fracture [24 months]

      incident fractures: vertebral (clinical and morphometric identified on VFA scans) and non-vertebral

    5. height [24 months]

      loss of height

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years to 85 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 424 General Military Hospital Thessaloniki Greece 56429

    Sponsors and Collaborators

    • 424 General Military Hospital

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Athanasios D. Anastasilakis, Consultant of endocrinology; in charge of the Department of Metabolic Bone Diseases, 424 General Military Hospital
    ClinicalTrials.gov Identifier:
    NCT05575167
    Other Study ID Numbers:
    • EURODEC
    First Posted:
    Oct 12, 2022
    Last Update Posted:
    Jan 25, 2023
    Last Verified:
    Jan 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Osteoporosis
    Osteoporosis, Postmenopausal
    Vitamin D
    Alendronate
    Zoledronic Acid

    Study Results

    No Results Posted as of Jan 25, 2023