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RECRUITINGOBSERVATIONAL

Sequential Therapies After Osteoanabolic Treatment

Efficacy of Sequential Therapies After Osteoanabolic Treatment in Postmenopausal Women With Severe Osteoporosis: the Sequential Treatment After Romosozumab and Teriparatide/Abaloparatide (START) Study

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

12-month prospective, open-label, multicenter, international, observational study evaluating sequential treatments after osteoanabolics

Who May Be Eligible (Plain English)

Who May Qualify: • Postmenopausal women treated with severe osteoporosis completing their course with romosozumab or teriparatide Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DRUG

Zoledronate

intravenous infusion

DRUG

Denosumab

subcutaneous injection

DRUG

Teriparatide

subcutaneous injection

DRUG

Romosozumab

subcutaneous injection

DRUG

Abaloparatide Injection (80 mcg)

daily subcutaneous injection

Locations (8)

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