Single or Repeat Zoledronate Versus Alendronate Following Denosumab (EUROpean Denosumab Effects Consolidation Study)
NCT ID: NCT05575167
Last Updated: 2025-04-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
125 participants
OBSERVATIONAL
2023-11-28
2027-11-30
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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
Zoledronate or Alendronate
infusion (for zoledronate) or oral digestion (for alendronate)
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
Zoledronate or Alendronate
infusion (for zoledronate) or oral digestion (for alendronate)
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
Zoledronate or Alendronate
infusion (for zoledronate) or oral digestion (for alendronate)
Interventions
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Zoledronate or Alendronate
infusion (for zoledronate) or oral digestion (for alendronate)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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)
50 Years
85 Years
FEMALE
No
Sponsors
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424 General Military Hospital
OTHER
Responsible Party
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Athanasios D. Anastasilakis
Consultant of endocrinology; in charge of the Department of Metabolic Bone Diseases
Principal Investigators
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Willem Lems, Prof
Role: PRINCIPAL_INVESTIGATOR
ECTS Clinical Action Group
Locations
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Univ. Lille, CHU Lille
Lille, , France
251 Hellenic Airforce and VA General Hospital
Athens, , Greece
First Department of Propaedeutic and Internal Medicine, Medical School, National and Kapodistrian University of Athens
Athens, , Greece
, KAT General Hospital
Athens, , Greece
424 General Military Hospital
Thessaloniki, , Greece
Fondazione IRCCS Cà Granda-Ospedale Maggiore Policlinico
Milan, , Italy
Campus Bio-Medico University
Roma, , Italy
Department of Medicine, Surgery and Neurosciences, University of Siena
Siena, , Italy
University-Hospital S. Maria della Misericordia
Udine, , Italy
Countries
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Central Contacts
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Facility Contacts
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Gaia Tabacco, PhD
Role: backup
Daniela Merlotti
Role: backup
Other Identifiers
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EURODEC
Identifier Type: -
Identifier Source: org_study_id
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