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

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05369013

Acronym

ESECTO

Enrollment

188

Registered

2022-05-11

Start date

2021-06-15

Completion date

2024-04-14

Last updated

2022-05-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoporosis

Keywords

Osteoporosis, Risk fracture, Postmenopausical, Forsteo, Movymia

Brief summary

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).

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Effectiveness for patients treatment with original	24 Months	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). .

Secondary

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

Countries

Spain

Outcome results