deltatrials
Unknown OBSERVATIONAL NCT05369013

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.

Conditions Osteoporosis
Updated 7 times since 2022 Last updated: May 10, 2022 Started: Jun 15, 2021 Primary completion: Dec 30, 2023 Completion: Apr 14, 2024
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

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

~Jun 2022 – ~Nov 2023 · 17 months · monthly snapshotActive Not Recruiting~Nov 2023 – ~Jun 2024 · 7 months · monthly snapshotActive Not Recruiting~Jun 2024 – ~Jul 2024 · 30 days · monthly snapshotUnknown Status~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotUnknown~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshotUnknown~Sep 2025 – present · 7 months · monthly snapshotUnknown~Jan 2026 – present · 3 months · monthly snapshotUnknown

Change History

7 versions recorded
  1. Jan 2026 — Present [monthly]

    Unknown

  2. Sep 2025 — Present [monthly]

    Unknown

  3. Sep 2024 — Sep 2025 [monthly]

    Unknown

  4. Jul 2024 — Sep 2024 [monthly]

    Unknown

    Status: Unknown StatusUnknown

  5. Jun 2024 — Jul 2024 [monthly]

    Unknown Status

    Status: Active Not RecruitingUnknown Status

Show 2 earlier versions
  1. Nov 2023 — Jun 2024 [monthly]

    Active Not Recruiting

  2. 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

Sponsor contact:
  • 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
Data source: STADA, Spain

For direct contact, visit the study record on ClinicalTrials.gov .