RecruitingNCT06164795

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

Sponsor

424 General Military Hospital

Enrollment

150 participants

Start Date

Nov 25, 2023

Study Type

OBSERVATIONAL

Conditions

Osteoporosis, Postmenopausal

Summary

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

Eligibility

Sex: FEMALEMin Age: 50 YearsMax Age: 85 Years

Inclusion Criteria1

• Postmenopausal women treated with severe osteoporosis completing their course with romosozumab or teriparatide

Exclusion Criteria8

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

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Interventions

DRUGZoledronate

intravenous infusion

DRUGDenosumab

subcutaneous injection

DRUGTeriparatide

subcutaneous injection

DRUGRomosozumab

subcutaneous injection

DRUGAbaloparatide 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

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NCT06164795

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