Sequential Therapies After Osteoanabolic Treatment
Recruiting · NCT06164795 · Observational (researchers observe without assigning treatment) · Lead sponsor: 424 General Military Hospital
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
12-month prospective, open-label, multicenter, international, observational study evaluating sequential treatments after osteoanabolics
Who can take part
Age range
50 Years to 85 Years
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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
Where it is running
8 locations listed.
- 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
- 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
- 424 General Military Hospital - Thessaloniki, Greece
- University-Hospital S. Maria della Misericordia - Udine, Italy