Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
150 participants
OBSERVATIONAL
2023-11-25
2027-05-31
Brief Summary
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Detailed Description
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Endpoints: Primary: BMD changes at the lumbar spine at 12 months. Secondary: i) BMD changes at the non-dominant femoral neck and total hip at 12 and 24 months; ii) changes at levels of bone turnover markers throughout the study; iii) incident fractures: vertebral (clinical and morphometric identified on VFA scans) and non-vertebral
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Romo-Zol group
Postmenopausal women treated with romosozumab for 12 months will receive a single zoledronate infusion (5mg) at 1 month after the last romosozumab dose
Zoledronate
intravenous infusion
Romo-Dmab group
Postmenopausal women treated with romosozumab for 12 months will receive subcutaneous denosumab injections (60mg) bi-annually for 12 months starting at 1 month after the last romosozumab dose
Denosumab
subcutaneous injection
Romo-PTH group
Postmenopausal women treated with romosozumab for 12 months will receive daily injections of teriparatide 20μg or abaloparatide 80μg for 12 months starting at 1 month after the last romosozumab dose
Teriparatide
subcutaneous injection
Abaloparatide Injection (80 mcg)
daily subcutaneous injection
PTH-Zol group
Postmenopausal women treated with teriparatide for 24 months or abaloparatide for 18 monthswill receive a single zoledronate infusion (5mg) at 1 month after the last romosozumab dose
Zoledronate
intravenous infusion
PTH-Dmab group
Postmenopausal women treated with teriparatide for 24 months or abaloparatide for 18 months will receive subcutaneous denosumab injections (60mg) bi-annually for 12 months
Denosumab
subcutaneous injection
TPTD-Romo group
Postmenopausal women treated with teriparatide for 24 months or abaloparatide for 18 months will receive month injections of romosozumab for 12 months
Romosozumab
subcutaneous injection
Interventions
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Zoledronate
intravenous infusion
Denosumab
subcutaneous injection
Teriparatide
subcutaneous injection
Romosozumab
subcutaneous injection
Abaloparatide Injection (80 mcg)
daily subcutaneous injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
50 Years
85 Years
FEMALE
No
Sponsors
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424 General Military Hospital
OTHER
Responsible Party
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Athanasios D. Anastasilakis
Head of the Department of Endocrinology
Principal Investigators
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Willem Lems, Prof
Role: STUDY_CHAIR
ECTS Clinical Action Group
Locations
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251 Airforce & 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
Countries
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Central Contacts
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Facility Contacts
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Gaia Tabacco, PhD
Role: backup
Daniela Merlotti
Role: backup
Other Identifiers
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START
Identifier Type: -
Identifier Source: org_study_id
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