UnknownNot Applicable

Study and Follow-up of the Clinical Effectiveness and Comparative Safety of Biosimilar Teriparatide in the Management of Postmenopausal or Senile.

Spain188 participantsStarted 2021-06-15

Plain-language 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 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.

Who can participate

Age range18 Years

SexALL

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Inclusion Criteria: * 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 Criteria: * The informed consent signature was not obtained. * Patients who meet any of the contraindications for the use of teriparatide.

What they're measuring

Effectiveness for patients treatment with original

Timeframe: 24 Months

Trial details

NCT IDNCT05369013

SponsorSTADA, Spain

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-12-30

View on ClinicalTrials.gov More Osteoporosis trials