Study and Follow-up of the Clinical Effectiveness and Comparative Safety of Biosimilar Teriparatide in the Management of Postmenopausal or Senile. (ESECTO)
Study and Follow-up of the Clinical Effectiveness and Comparative Safety of Biosimilar Teriparatide in the Management of Postmenopausal or Senile (ESECTO)
Sponsor: Alpha Bioresearch S.L.
This observational or N/A phase trial investigates Osteoporosis and is currently ongoing. Alpha Bioresearch S.L. leads this study, which shows 7 recorded versions since 2021 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.
Study Description(click to expand)Non-interventional observational prospective follow-up study of cohorts of patients with Previous diagnosis of Osteoporosis with high risk of fractures, with/without previous fractures and treatment with bone formers (biosimilar or original Teriparatide), who meet all the inclusion criteria and exclusion, with prior information and signing of prior informed consent documents.
Primary objective:
Verify the clinical effectiveness of Teriparatide Biosimilar under clinical practice conditions real. Compare this clinical effectiveness with original Teriparatide administered under similar conditions of actual clinical practice. Design: Observational cohort study, prospective, multicenter, nationwide. Study population: Patients with a previous diagnosis of Osteoporosis with a high risk of fractures,with/without previous fractures and in treatment with bone formers since before the start of the study. The patients will be distributed into 2 cohorts based on whether they are receiving similar Teriparatide (cohort A) or original Teriparatide (Cohort B).
Non-interventional observational prospective follow-up study of cohorts of patients with Previous diagnosis of Osteoporosis with high risk of fractures, with/without previous fractures and treatment with bone formers (biosimilar or original Teriparatide), who meet all the inclusion criteria and exclusion, with prior information and signing of prior informed consent documents.
Primary objective:
Verify the clinical effectiveness of Teriparatide Biosimilar under clinical practice conditions real. Compare this clinical effectiveness with original Teriparatide administered under similar conditions of actual clinical practice. Design: Observational cohort study, prospective, multicenter, nationwide. Study population: Patients with a previous diagnosis of Osteoporosis with a high risk of fractures,with/without previous fractures and in treatment with bone formers since before the start of the study. The patients will be distributed into 2 cohorts based on whether they are receiving similar Teriparatide (cohort A) or original Teriparatide (Cohort B).
Status Flow
Change History
7 versions recorded-
Jan 2026 — Present [monthly]
Unknown
-
Sep 2025 — Present [monthly]
Unknown
-
Sep 2024 — Sep 2025 [monthly]
Unknown
-
Jul 2024 — Sep 2024 [monthly]
Unknown
Status: Unknown Status → Unknown
-
Jun 2024 — Jul 2024 [monthly]
Unknown Status
Status: Active Not Recruiting → Unknown Status
▶ Show 2 earlier versions
-
Nov 2023 — Jun 2024 [monthly]
Active Not Recruiting
-
Jun 2022 — Nov 2023 [monthly]
Active Not Recruiting
First recorded
Jun 2021
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Alpha Bioresearch S.L.
- Complexo Hospitalario de Ourense
- Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
- Hospital Universitario Central de Asturias
- Hospital Universitario Fundación Jiménez Díaz
- Hospital Universitario Infanta Leonor
- Hospital Universitario Virgen Macarena
- Hospital d´Igualada
- Instituto Palacios
- Parc Taulí Hospital Universitari
- STADA, Spain
For direct contact, visit the study record on ClinicalTrials.gov .