Zoledronate
Drugintravenous infusion
Other names: zoledronic acid; zolendronate
NCT Number: NCT06164795
12-month prospective, open-label, multicenter, international, observational study evaluating sequential treatments after osteoanabolics
Interested in participating?
Request Info50 year–85 year
Female
Observational
, KAT General Hospital, Athens, Greece
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
intravenous infusion
Other names: zoledronic acid; zolendronate
subcutaneous injection
Other names: Dmab
subcutaneous injection
Other names: TPTD
subcutaneous injection
Other names: Romo
daily subcutaneous injection
Time frame: baseline to 12 months
bone mineral density changes at the lumbar spine at 12 months measured by dual-energy absorptiometry (DXA)
Time frame: baseline to 12 months
bone mineral density changes at the femoral neck at 12 months measured by dual-energy absorptiometry (DXA)
Time frame: baseline to 12 months
bone mineral density changes at the total hip at 12 months measured by dual-energy absorptiometry (DXA)
Time frame: baseline, 3 months, 6 months, 12 months
bone turnover (formation) marker
Time frame: baseline, 3 months, 6 months, 12 months
bone turnover (resorption) marker
Time frame: 12 months
incident fractures: vertebral (clinical and morphometric identified on VFA scans) and non-vertebral
Contact information is provided by the study sponsor or research team.
424 General Military Hospital
Other
Efficacy of Sequential Therapies After Osteoanabolic Treatment in Postmenopausal Women With Severe Osteoporosis: the Sequential Treatment After Romosozumab and Teriparatide/Abaloparatide (START) Study
Acronym: START
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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