RECRUITINGOBSERVATIONAL
Single or Repeat Zoledronate Versus Alendronate Following Denosumab (EUROpean Denosumab Effects Consolidation Study)
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
About This Trial
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
Who May Be Eligible (Plain English)
Who May Qualify:
• Postmenopausal women treated with denosumab for 3 or more years who will reach osteopenia
Who Should NOT Join This Trial:
- 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)
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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)
Treatments Being Tested
DRUG
Zoledronate or Alendronate
infusion (for zoledronate) or oral digestion (for alendronate)
Locations (9)
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