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

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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Study and Follow-up of the Clinical Effectiveness and Comparative Safety of Biosimilar Teriparatide in the Management of Postmenopausal or Senile (ESECTO)

Conditions
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Osteoporosis

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| A<br>Biosimilar Teriparatide | |
| B<br>Original Teriparatide | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). . | 24 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 30 Months | 
| Demographic and personal aspects related to the risk of osteoporosis | age, sex, province of residence, year of diagnosis of OP. | 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. | 30 Months | 
| Previous clinical data | Family history of interest as per clinical practice. This information will be available at Clinical Records for each patients. | 24 Months | 
| Anthropometric clinical data | weight and height will be combined to report BMI in kg/m^2 | 24 Months | 
| Osteoporosis diagnosis | By BMD; BMD data in CL and hip, measured value in g/cm2 and T-Score value. | 24 Months | 
| TBS | TBS value | 24 Months | 
| FRAX | FRAX value of hip and major fracture. | 24 Months | 
| Bone remodelling biomarkers | Combined information described by: BGP (ng/ml), CTX (ng/ml), NTX (nmol/nmol creatine), P1NP (ng/ml), 25 OH vitamin D (ng/ml), intact PTH (pg/ml), TSH uUl/ml), Testosterone (ng/ml), Estradiol (pg/ml), Calcium (mg/dl), Phosphorus (mg/dl).This information will be collected in 194 patients who were recruited in this study. This information will be collected as per protocol during 30months. Physicians will evaluated this parameters as per clinical practice. | 24 Months | 
| Hepatic profile | Combined information described by: SGPT (U/L), SGOT (U/L), Gamma GT (U/L), FA (U/L), BT (mg/dl). This information will be collected in 194 patients who were recruited in this study. This information will be collected as per protocol during 30months. Physicians will evaluated this parameters as per clinical practice. | 24 Months | 
| Previous bone fractures | Number and type of previous fractures. | 30 Months | 
| Previous treatment for osteoporosis | Previous treatment of osteoporosis indicated as yes or no. This information will be available at Clinical Records for each patients.This information will be collected in 194 patients who were recruited in this study. This information will be collected as per protocol during 30months. Physicians will evaluated this parameters as per clinical practice. | 24 Months | 
| Complementary previous treatment for osteoporosis | Previous complementary treatment with Vitamin D and/or Calcium. | 24 Months | 
| Security profile | Number of secondary effects. Each secondary effects will be evaluted according to medical criterion.This information will be collected in 194 patients who were recruited in this study. This information will be collected as per protocol during 30months. Physicians will evaluated this parameters as per clinical practice. Day of start/end will be indicated. | 30 Months | 
| Bone fractures during treatment | Number of fractures during treatment. | 24 Months | 
| Falls | Number of falls during the treatment. | 24 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Osteoporosis, Risk fracture, Postmenopausical, Forsteo, Movymia