RecruitingNCT05575167
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
Sponsor
424 General Military Hospital
Enrollment
125 participants
Start Date
Nov 28, 2023
Study Type
OBSERVATIONAL
Conditions
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: FEMALEMin Age: 50 YearsMax Age: 85 Years
Inclusion Criteria1
- • Postmenopausal women treated with denosumab for 3 or more years who will reach osteopenia
Exclusion Criteria7
- 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)
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Interventions
DRUGZoledronate or Alendronate
infusion (for zoledronate) or oral digestion (for alendronate)
Locations(9)
View Full Details on ClinicalTrials.gov
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NCT05575167
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