Status:
UNKNOWN
Study and Follow-up of the Clinical Effectiveness and Comparative Safety of Biosimilar Teriparatide in the Management of Postmenopausal or Senile.
Lead Sponsor:
STADA, Spain
Collaborating Sponsors:
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Instituto Palacios
Conditions:
Osteoporosis
Eligibility:
All Genders
18+ years
Brief Summary
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 w...
Detailed Description
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 w...
Eligibility Criteria
Inclusion
- Signing the Informed Consent Men or women of legal age who have completed somatic growth.
- Previous diagnosis of densitometric osteoporosis in any location (densitometry with DEXA diagnosis within 6 months prior to start of treatment) or previous diagnosis of established osteoporosis (due to previous low-impact fracture, central or peripheral)
- Being in previous treatment with similar Teriparatide (cohort A) or with original Teriparatide (Cohort B).
- Be in possession of mental faculties to understand the therapeutic proposal, understand and follow the follow-up protocol and be able to sign the consent document informed.
Exclusion
- The informed consent signature was not obtained.
- Patients who meet any of the contraindications for the use of teriparatide.
Key Trial Info
Start Date :
June 15 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 14 2024
Estimated Enrollment :
188 Patients enrolled
Trial Details
Trial ID
NCT05369013
Start Date
June 15 2021
End Date
April 14 2024
Last Update
May 17 2022
Active Locations (10)
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1
Hospital Parc Taulí
Barcelona, Spain
2
Hospital Universitario Igualada
Barcelona, Spain
3
Hospital 12 de Octubre
Madrid, Spain
4
Hospital de La Princesa
Madrid, Spain