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
| Registry | NCT05575167, acronym EURODEC |
|---|---|
| Status | Active not recruiting |
| Study type | Observational |
| Enrollment | 122 (Actual) |
| Sponsor | 424 General Military Hospital (Other); collaborators: Laikο General Hospital, Athens, 251 Hellenic Air Force & VA General Hospital, Campus Bio-Medico University |
| Conditions | Osteoporosis, Postmenopausal |
| Interventions | Zoledronate or Alendronate (Drug) |
| Dates | start 2023-11-28, primary completion 2027-07-01 (estimated), completion 2027-11-01 (estimated), first posted 2022-10-12, last updated 2026-07-22 |
| Locations | 9 sites in France, Greece, Italy |
Related Papers Related Patents Related Grants Related Experts
All trials for Osteoporosis, Postmenopausal All trials of Zoledronate or Alendronate
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
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
| Arm | Type | Interventions | Description |
|---|---|---|---|
| single Zol group | Drug: Zoledronate or Alendronate | 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 | |
| double Zol group | Drug: Zoledronate or Alendronate | 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 | |
| ALN group | Drug: Zoledronate or Alendronate | 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 |
Sex: Female, ages: 50 Years to 85 Years
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)
| Facility | City | Country | 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 |