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)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Osteoporosis

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 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 (Anticipated): 188

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain
    • Hospital Parc Tauli
  • Barcelona, Spain
    • Hospital Universitario Igualada
  • Madrid, Spain
    • Hospital 12 de Octubre
  • Madrid, Spain
    • Hospital Infanta Leonor
  • Madrid, Spain
    • Hospital de La Princesa
  • Madrid, Spain
    • Hospital Fundacion Jimenez Diaz
  • Madrid, Spain
    • Instituto Palacio de Madrid
  • Orense, Spain
    • Complejo Hospitalario Universitario de Orense
  • Oviedo, Spain
    • Hospital Universitario Central de Asturias
  • Sevilla, Spain
    • Hospital Virgen Macarena

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with 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).

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
A; Biosimilar Teriparatide
B; Original Teriparatide

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: STADA, Spain
• Collaborators: Hospital Universitario Virgen Macarena; Alpha Bioresearch S.L.; Hospital Universitario Infanta Leonor; Hospital Universitario Fundación Jiménez Díaz; Fundación de Investigación Biomédica - Hospital Universitario de La Princesa; Hospital Universitario Central de Asturias; Hospital Parc Taulí, Sabadell; Instituto Palacios; Complexo Hospitalario de Ourense; Hospital d´Igualada
• Investigators: Study Director: Santiago Palacios, Instituto Palacios de la Salud de la Mujer. Presidente FHOEMO; Study Director: Jose Luis Neyro, Hospital Universitario Cruces. Embajador FHOEMO

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2021
• Primary Completion (Anticipated): December 30, 2023
• Study Completion (Anticipated): April 14, 2024

Study Registration Dates

• First Submitted: April 13, 2022
• First Submitted That Met QC Criteria: May 4, 2022
• First Posted (Actual): May 11, 2022

Study Record Updates

• Last Update Posted (Actual): May 17, 2022
• Last Update Submitted That Met QC Criteria: May 10, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Osteoporosis; Forsteo; Risk fracture; Postmenopausical; Movymia
• Additional Relevant MeSH Terms: Metabolic Diseases; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Metabolic; Osteoporosis
• Other Study ID Numbers: FHO-TER-2020-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO