Clinical Trials in Italy / NCT05575167
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
Condition(s) studied
Osteoporosis, Postmenopausal
Investigational drug(s) / intervention(s)
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
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)
| Facility | City | Region | Status |
|---|---|---|---|
| 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