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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05575167
Other study ID # EURODEC
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 28, 2023
Est. completion date November 2026

Study information

Verified date November 2023
Source 424 General Military Hospital
Contact Athanasios D Anastasilakis, MD
Phone 2310381431
Email a.anastasilakis@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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


Description:

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


Recruitment information / eligibility

Status Recruiting
Enrollment 125
Est. completion date November 2026
Est. primary completion date November 2026
Accepts healthy volunteers No
Gender Female
Age group 50 Years to 85 Years
Eligibility 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)

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Zoledronate or Alendronate
infusion (for zoledronate) or oral digestion (for alendronate)

Locations

Country Name City State
France Univ. Lille, CHU Lille Lille
Germany Department of Medicine III and Center for Healthy Aging, Technische Universität Dresden Dresden
Greece , KAT General Hospital Athens
Greece 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 424 General Military Hospital Thessaloniki
Italy 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

Sponsors (1)

Lead Sponsor Collaborator
424 General Military Hospital

Countries where clinical trial is conducted

France,  Germany,  Greece,  Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary lumbar spine BMD BMD changes at the lumbar spine at 12 and 24 months 24 months
Secondary femoral neck BMD BMD changes at the non-dominant femoral neck and total hip at 12 and 24 months 24 months
Secondary P1NP bone turnover (formation) marker baseline, 3 months, 6 months, 12 months, 18 months, 24 months
Secondary CTx bone turnover (resorption) marker 24 months
Secondary fracture incident fractures: vertebral (clinical and morphometric identified on VFA scans) and non-vertebral 24 months
Secondary height loss of height 24 months
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