Clinical Trials in Italy / NCT06164795
Recruiting
Observational
Sequential Therapies After Osteoanabolic Treatment
NCT06164795 · tracked via the Priya Life Science Italy tracker
Condition(s) studied
Osteoporosis, Postmenopausal
Investigational drug(s) / intervention(s)
Zoledronate: intravenous infusion
Denosumab: subcutaneous injection
Teriparatide: subcutaneous injection
Romosozumab: subcutaneous injection
Abaloparatide Injection (80 mcg): daily subcutaneous injection
Study summary
12-month prospective, open-label, multicenter, international, observational study evaluating sequential treatments after osteoanabolics
Eligibility
Inclusion Criteria:
• Postmenopausal women treated with severe osteoporosis completing their course with romosozumab or teriparatide
Exclusion Criteria:
* a bone disease other than postmenopausal osteoporosis
* use of medications other than romosozumab or teriparatide 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)
* hypersensitivity to denosumab or zoledronate or teriparatide or romosozumab or any of the excipients
Primary outcome measure(s)
- lumbar spine bone mineral density — baseline to 12 months
bone mineral density changes at the lumbar spine at 12 months measured by dual-energy absorptiometry (DXA)
Trial sites (8)
| Facility | City | Region | Status |
|---|---|---|---|
| 251 Airforce & VA General Hospital | Athens | Greece | Recruiting |
| First Department of Propaedeutic and Internal Medicine, Medical School, National and Kapodistrian University of Athens | Athens | Greece | Recruiting |
| , KAT General Hospital | Athens | Greece | Recruiting |
| 424 General Military Hospital | Thessaloniki | Greece | Recruiting |
| Fondazione IRCCS Cà Granda-Ospedale Maggiore Policlinico | Milan | Italy | Recruiting |
| Campus Bio-Medico University | Roma | Italy | Recruiting |
| Department of Medicine, Surgery and Neurosciences, University of Siena | Siena | Italy | Recruiting |
| University-Hospital S. Maria della Misericordia | Udine | Italy | Recruiting |
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 NCT06164795 on ClinicalTrials.gov ↗ ← All trials in Italy