Status:
RECRUITING
Sequential Therapies After Osteoanabolic Treatment
Lead Sponsor:
424 General Military Hospital
Conditions:
Osteoporosis, Postmenopausal
Eligibility:
FEMALE
50-85 years
Brief Summary
12-month prospective, open-label, multicenter, international, observational study evaluating sequential treatments after osteoanabolics
Detailed Description
Caucasian women with severe postmenopausal osteoporosis who have completed their course with romosozumab or a PTH analog will be assigned to one of the following 3 options: i) zoledronate 5mg infusion...
Eligibility Criteria
Inclusion
- • Postmenopausal women treated with severe osteoporosis completing their course with romosozumab or teriparatide
Exclusion
- a bone disease other than postmenopausal osteoporosis
- use of medications other than romosozumab or teriparatide 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)
- hypersensitivity to denosumab or zoledronate or teriparatide or romosozumab or any of the excipients
Key Trial Info
Start Date :
November 25 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 1 2027
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06164795
Start Date
November 25 2023
End Date
May 1 2027
Last Update
April 27 2025
Active Locations (8)
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1
251 Airforce & VA General Hospital
Athens, Greece, 11525
2
First Department of Propaedeutic and Internal Medicine, Medical School, National and Kapodistrian University of Athens
Athens, Greece, 11527
3
, KAT General Hospital
Athens, Greece, 14561
4
424 General Military Hospital
Thessaloniki, Greece, 56429