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Active, not recruiting Observational

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

NCT05575167 · tracked via the Priya Life Science Italy tracker
Sponsor
424 General Military Hospital
Phase
Observational
Started
2023-11-28
Last updated
2026-07-22

Condition(s) studied

Osteoporosis, Postmenopausal

Investigational drug(s) / intervention(s)

Zoledronate or AlendronateAll Zoledronate trials (8) →All Alendronate trials (4) →

Zoledronate or Alendronate: infusion (for zoledronate) or oral digestion (for alendronate)

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

Sex
FEMALE
Min age
50 Years
Max age
85 Years
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)

Primary outcome measure(s)

  • lumbar spine BMD — 24 months
    BMD changes at the lumbar spine at 12 and 24 months

Trial sites (9)

FacilityCityRegionStatus
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

More 424 General Military Hospital trials in Italy

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05575167 on ClinicalTrials.gov ↗ ← All trials in Italy