12-month prospective, open-label, multicenter, international, observational study evaluating sequential treatments after osteoanabolics
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 or ii) denosumab subcutaneous injections or iii) teriparatide or abaloparatide (for those previously treated with romosozumab) or romosozumab (for those previously treated with teriparatide or abaloparatide). 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
Study Type
OBSERVATIONAL
Enrollment
150
intravenous infusion
subcutaneous injection
subcutaneous injection
251 Airforce & VA General Hospital
Athens, Greece
RECRUITINGFirst Department of Propaedeutic and Internal Medicine, Medical School, National and Kapodistrian University of Athens
Athens, Greece
RECRUITING, KAT General Hospital
lumbar spine bone mineral density
bone mineral density changes at the lumbar spine at 12 months measured by dual-energy absorptiometry (DXA)
Time frame: baseline to 12 months
femoral neck bone mineral density
bone mineral density changes at the femoral neck at 12 months measured by dual-energy absorptiometry (DXA)
Time frame: baseline to 12 months
total hip bone mineral density
bone mineral density changes at the total hip at 12 months measured by dual-energy absorptiometry (DXA)
Time frame: baseline to 12 months
P1NP
bone turnover (formation) marker
Time frame: baseline, 3 months, 6 months, 12 months
CTx
bone turnover (resorption) marker
Time frame: baseline, 3 months, 6 months, 12 months
Fractures
incident fractures: vertebral (clinical and morphometric identified on VFA scans) and non-vertebral
Time frame: 12 months
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subcutaneous injection
daily subcutaneous injection
Athens, Greece
424 General Military Hospital
Thessaloniki, Greece
RECRUITINGFondazione IRCCS Cà Granda-Ospedale Maggiore Policlinico
Milan, Italy
RECRUITINGCampus Bio-Medico University
Roma, Italy
RECRUITINGDepartment of Medicine, Surgery and Neurosciences, University of Siena
Siena, Italy
RECRUITINGUniversity-Hospital S. Maria della Misericordia
Udine, Italy
RECRUITING