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
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