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

Osteoporosis Clinical Trial

— ESECTO  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05369013
• Other study ID #: FHO-TER-2020-01
• Status: Active, not recruiting
• Start date: June 15, 2021
• Est. completion date: April 14, 2024

Study information

• Verified date: May 2022
• Source: STADA, Spain
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 188
• Est. completion date: April 14, 2024
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Osteoporosis

Locations

Country	Name	City	State
Spain	Hospital Parc Taulí	Barcelona
Spain	Hospital Universitario Igualada	Barcelona
Spain	Hospital 12 de Octubre	Madrid
Spain	Hospital de La Princesa	Madrid
Spain	Hospital Fundación Jimenez Diaz	Madrid
Spain	Hospital Infanta Leonor	Madrid
Spain	Instituto Palacio de Madrid	Madrid
Spain	Complejo Hospitalario Universitario de Orense	Orense
Spain	Hospital Universitario Central de Asturias	Oviedo
Spain	Hospital Virgen Macarena	Sevilla

Sponsors (11)

Lead Sponsor	Collaborator
STADA, Spain	Alpha Bioresearch S.L., Complexo Hospitalario de Ourense, Fundación de Investigación Biomédica - Hospital Universitario de La Princesa, Hospital d´Igualada, Hospital Parc Taulí, Sabadell, Hospital Universitario Central de Asturias, Hospital Universitario Fundación Jiménez Díaz, Hospital Universitario Infanta Leonor, Hospital Universitario Virgen Macarena, Instituto Palacios

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Demographic and personal aspects related to the risk of osteoporosis	age, sex, province of residence, year of diagnosis of OP.	24 Months
Secondary	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
Secondary	Previous clinical data	Family history of interest as per clinical practice. This information will be available at Clinical Records for each patients.	24 Months
Secondary	Anthropometric clinical data	weight and height will be combined to report BMI in kg/m^2	24 Months
Secondary	Osteoporosis diagnosis	By BMD; BMD data in CL and hip, measured value in g/cm2 and T-Score value.	24 Months
Secondary	TBS	TBS value	24 Months
Secondary	FRAX	FRAX value of hip and major fracture.	24 Months
Secondary	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
Secondary	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
Secondary	Previous bone fractures	Number and type of previous fractures.	30 Months
Secondary	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
Secondary	Complementary previous treatment for osteoporosis	Previous complementary treatment with Vitamin D and/or Calcium.	24 Months
Secondary	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
Secondary	Bone fractures during treatment	Number of fractures during treatment.	24 Months
Secondary	Falls	Number of falls during the treatment.	24 Months