NCT05575167 Single or Repeat Zoledronate Versus Alendronate Following Denosumab (EUROpean Denosumab Effects Consolidation Study)
| NCT ID | NCT05575167 |
| Status | Recruiting |
| Phase | — |
| Sponsor | 424 General Military Hospital |
| Condition | Osteoporosis, Postmenopausal |
| Study Type | OBSERVATIONAL |
| Enrollment | 125 participants |
| Start Date | 2023-11-28 |
| Primary Completion | 2027-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 125 participants in total. It began in 2023-11-28 with a primary completion date of 2027-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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)
Contact & Investigator
Willem Lems, Prof
PRINCIPAL INVESTIGATOR
ECTS Clinical Action Group
Frequently Asked Questions
Who can join the NCT05575167 clinical trial?
This trial is open to female participants only, aged 50 Years or older, up to 85 Years, studying Osteoporosis, Postmenopausal. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05575167 currently recruiting?
Yes, NCT05575167 is actively recruiting participants. Contact the research team at a.anastasilakis@gmail.com for enrollment information.
Where is the NCT05575167 trial being conducted?
This trial is being conducted at Lille, France, Athens, Greece, Athens, Greece, Athens, Greece and 5 additional locations.
Who is sponsoring the NCT05575167 clinical trial?
NCT05575167 is sponsored by 424 General Military Hospital. The principal investigator is Willem Lems, Prof at ECTS Clinical Action Group. The trial plans to enroll 125 participants.