Current partner codePEPTIDESDE
NCT05369013·Not applicable·OBSERVATIONAL

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

Status

Unknown

Phase

Not applicable

Enrollment

188

Locations

10

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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.

Full 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

Treatment arms and agents.

No intervention details reported.

Timeline

From registration to results.

  1. First posted

    May 11, 2022

  2. Study start

    Jun 15, 2021

  3. Primary completion

    Dec 30, 2023

  4. Study completion

    Apr 14, 2024

  5. Results posted

    Not reported

  6. Registry updated

    May 17, 2022

Outcomes

What the study measures.

Primary outcomes

Effectiveness for patients treatment with original

Time frame · 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 outcomes

Confirm fracture rate in any localization while study is ongoing

Time frame · 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.

Demographic and personal aspects related to the risk of osteoporosis

Time frame · 24 Months

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

Risk factor of osteoporosis

Time frame · 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

Time frame · 24 Months

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

Anthropometric clinical data

Time frame · 24 Months

weight and height will be combined to report BMI in kg/m\^2

Osteoporosis diagnosis

Time frame · 24 Months

By BMD; BMD data in CL and hip, measured value in g/cm2 and T-Score value.

TBS

Time frame · 24 Months

TBS value

FRAX

Time frame · 24 Months

FRAX value of hip and major fracture.

Bone remodelling biomarkers

Time frame · 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.

Hepatic profile

Time frame · 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.

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
ALL
Healthy volunteers
No

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 locations

10 registered sites.

Spain. Showing up to 24 locations stored in the fast local snapshot.

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

Ourense, Spain

Hospital Universitario Central de Asturias

Oviedo, Spain

Hospital Virgen Macarena

Seville, Spain

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Teriparatide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.