Osteoporosis, Postmenopausal Clinical Trial
— STARTOfficial title:
Efficacy of Sequential Therapies After Osteoanabolic Treatment in Postmenopausal Women With Severe Osteoporosis: the Sequential Treatment After Romosozumab and Teriparatide (START) Study
NCT number | NCT06164795 |
Other study ID # | START |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | November 25, 2023 |
Est. completion date | December 2025 |
12-month prospective, open-label, multicenter, international, observational study evaluating sequential treatments after osteoanabolics
Status | Recruiting |
Enrollment | 150 |
Est. completion date | December 2025 |
Est. primary completion date | December 2025 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 50 Years to 85 Years |
Eligibility | Inclusion Criteria: • Postmenopausal women treated with severe osteoporosis completing their course with romosozumab or teriparatide Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Germany | Department of Medicine III and Center for Healthy Aging, Technische Universität Dresden | Dresden | |
Greece | , KAT General Hospital | Athens | |
Greece | 251 Airforce & 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 |
Lead Sponsor | Collaborator |
---|---|
424 General Military Hospital |
Germany, Greece, Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | lumbar spine bone mineral density | bone mineral density changes at the lumbar spine at 12 months measured by dual-energy absorptiometry (DXA) | baseline to 12 months | |
Secondary | femoral neck bone mineral density | bone mineral density changes at the femoral neck at 12 months measured by dual-energy absorptiometry (DXA) | baseline to 12 months | |
Secondary | total hip bone mineral density | bone mineral density changes at the total hip at 12 months measured by dual-energy absorptiometry (DXA) | baseline to 12 months | |
Secondary | P1NP | bone turnover (formation) marker | baseline, 3 months, 6 months, 12 months | |
Secondary | CTx | bone turnover (resorption) marker | baseline, 3 months, 6 months, 12 months | |
Secondary | Fractures | incident fractures: vertebral (clinical and morphometric identified on VFA scans) and non-vertebral | 12 months |
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