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

STADA, Spain188 enrolled

Overview

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).

Study Type

OBSERVATIONAL

Enrollment

188

Conditions

Osteoporosis

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (10)

Hospital Parc Taulí

Barcelona, Spain

Hospital Universitario Igualada

Barcelona, Spain

Hospital 12 de Octubre

Madrid, Spain

Hospital de La Princesa

Madrid, Spain

Outcomes

Primary Outcomes

Effectiveness for patients treatment with original

At the different moments of analysis (6, 12 and 24 months of treatment) in each of the treatment groups will be presented. The 95% confidence interval will be calculated for the mean percent change difference between groups. Likewise, the Student's t-test will be calculated for independent samples to assess statistical significance. To determine the fracture rate of any location during the study, the percentage of patients in each of the groups will be calculated descriptively. This proportion of patients will be compared between groups using Pearson's Chi-square test or Fisher's exact test, when applicable. The baseline-final change in biochemical markers of bone remodeling (BRM) between treatment groups will also be evaluated through the Student's t-test for independent samples if they meet the normality parameters or, failing that, its corresponding non-parametric test. (Mann-Whitney U test). .

Time frame: 24 Months

Secondary Outcomes

Confirm fracture rate in any localization while study is ongoing

In order to determinate fracture rate from any localization, patient´s percentage from each group will be calculated in a descriptive way using: Bone fractures during treatment Falls.

Time frame: 30 Months

Demographic and personal aspects related to the risk of osteoporosis

age, sex, province of residence, year of diagnosis of OP.

Time frame: 24 Months

Risk factor of osteoporosis

As per previous patient´s medical records. Phisician will evaluated risk factor as per clinical practice. This information will be available at Clinical Records for each patients.

Time frame: 30 Months

Previous clinical data

Family history of interest as per clinical practice. This information will be available at Clinical Records for each patients.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.