OsteoporosisESECTONCT05369013
Study and Follow-up of the Clinical Effectiveness and Comparative Safety of Biosimilar Teriparatide in the Management of Postmenopausal or Senile.
An observational study of Osteoporosis, run by STADA, Spain at 10 sites in Spain.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoporosis
- How many people
- 188 participants
- Where
- 10 sitesSpain
- Study dates
- 15 Jun 2021to 14 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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.
Who cannot join
- The informed consent signature was not obtained.
- Patients who meet any of the contraindications for the use of teriparatide.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Spain10 sites
Hospital Parc Taulí
Barcelona
Hospital Universitario Igualada
Barcelona
Hospital 12 de Octubre
Madrid
Hospital de La Princesa
Madrid
Hospital Fundación Jimenez Diaz
Madrid
Hospital Infanta Leonor
Madrid
Instituto Palacio de Madrid
Madrid
Complejo Hospitalario Universitario de Orense
Ourense
Hospital Universitario Central de Asturias
Oviedo
Hospital Virgen Macarena
Seville
About this study
Official title: 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.
Read the 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).
- Conditions
- Osteoporosis
- Keywords
- Osteoporosis, Risk fracture, Postmenopausical, Forsteo, Movymia
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| A | Biosimilar Teriparatide | |
| B | Original Teriparatide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
.
Measured: 24 Months
Secondary outcomes (16)
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.
Measured: 30 Months
Demographic and personal aspects related to the risk of osteoporosis
age, sex, province of residence, year of diagnosis of OP.
Measured: 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.
Measured: 30 Months
Previous clinical data
Family history of interest as per clinical practice. This information will be available at Clinical Records for each patients.
Measured: 24 Months
Anthropometric clinical data
weight and height will be combined to report BMI in kg/m^2
Measured: 24 Months
Osteoporosis diagnosis
By BMD; BMD data in CL and hip, measured value in g/cm2 and T-Score value.
Measured: 24 Months
TBS
TBS value
Measured: 24 Months
FRAX
FRAX value of hip and major fracture.
Measured: 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.
Measured: 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.
Measured: 24 Months
Previous bone fractures
Number and type of previous fractures.
Measured: 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.
Measured: 24 Months
Complementary previous treatment for osteoporosis
Previous complementary treatment with Vitamin D and/or Calcium.
Measured: 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.
Measured: 30 Months
Bone fractures during treatment
Number of fractures during treatment.
Measured: 24 Months
Falls
Number of falls during the treatment.
Measured: 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2022
- Study start15 Jun 2021
- Primary completion30 Dec 2023 (estimated)
- Study completion14 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 188 participants (estimated)
Sponsor and investigators
- Lead sponsor
- STADA, Spain
- Sponsor type
- University, hospital or other
- Collaborators
- Fundación de Investigación Biomédica - Hospital Universitario de La Princesa, Instituto Palacios, Complexo Hospitalario de Ourense, Hospital Universitario Central de Asturias, Parc Taulí Hospital Universitari, Hospital Universitario Fundación Jiménez Díaz, Hospital Universitario Infanta Leonor, Hospital Universitario Virgen Macarena, Hospital d'Igualada, Alpha Bioresearch S.L.
- Responsible party
- Sponsor
- Investigators
- Santiago Palacios, Study director, Instituto Palacios de la Salud de la Mujer. Presidente FHOEMOJose Luis Neyro, Study director, Hospital Universitario Cruces. Embajador FHOEMO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05369013
- Sponsor's protocol ID
- FHO-TER-2020-01
- Acronym
- ESECTO
- Status last verified
- May 2022
- First submitted
- 13 Apr 2022
- Last updated
- 17 May 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study and Follow-up of the Clinical Effectiveness and Comparative Safety of Biosimilar Teriparatide in the Management of Postmenopausal or Senile (ESECTO)
- ClinicalTrials.gov ID
- NCT05369013
- Acronym / sponsor ID
- ESECTO / FHO-TER-2020-01
- Conditions
- Osteoporosis
- Keywords
- Osteoporosis, Risk fracture, Postmenopausical, Forsteo, Movymia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 188 participants (estimated)
- Lead sponsor
- STADA, SpainUniversity, hospital or other
- Collaborators
- Fundación de Investigación Biomédica - Hospital Universitario de La Princesa, Instituto Palacios, Complexo Hospitalario de Ourense, Hospital Universitario Central de Asturias, Parc Taulí Hospital Universitari, Hospital Universitario Fundación Jiménez Díaz, Hospital Universitario Infanta Leonor, Hospital Universitario Virgen Macarena, Hospital d'Igualada, Alpha Bioresearch S.L.
- Study start
- 15 Jun 2021 (actual)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 14 Apr 2024 (estimated)
- First posted
- 11 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | – | –Biosimilar Teriparatide |
| B | – | –Original Teriparatide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- The informed consent signature was not obtained.
- Patients who meet any of the contraindications for the use of teriparatide.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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). .
16 secondary outcomes
Confirm fracture rate in any localization while study is ongoing
Time frame: 30 Months
Demographic and personal aspects related to the risk of osteoporosis
Time frame: 24 Months
Risk factor of osteoporosis
Time frame: 30 Months
Previous clinical data
Time frame: 24 Months
Anthropometric clinical data
Time frame: 24 Months
Osteoporosis diagnosis
Time frame: 24 Months
TBS
Time frame: 24 Months
FRAX
Time frame: 24 Months
Bone remodelling biomarkers
Time frame: 24 Months
Hepatic profile
Time frame: 24 Months
Previous bone fractures
Time frame: 30 Months
Previous treatment for osteoporosis
Time frame: 24 Months
Complementary previous treatment for osteoporosis
Time frame: 24 Months
Security profile
Time frame: 30 Months
Bone fractures during treatment
Time frame: 24 Months
Falls
Time frame: 24 Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2022.
- Individual participant dataSharing planned: No
Related trials for Osteoporosis
RecruitingObservational study
A Clinical Study to Collect Real-wordt Data on Safety and Clinical Performance of the VCFix Spinal System for Treatment of Vertebral Compression Fractures of (Suspected) Osteoporotic Origin.
Vertebra Compression Fracture
Active, not recruitingObservational study
The Impact of Osteosarcopenia on Falls, Kinesiophobia, and Quality of Life in Postmenopausal Women
Osteosarcopenia, Sarcopenia
Active, not recruitingPhase 2
TCM Formula vs. HMB in Pre-Frail Elders: Muscle Strength and Bone Status
Pre-Frailty, Sarcopenia
Not yet recruitingPhase 4
Romosozumab and Denosumab Combination Therapy for Osteoporosis
Postmenopausal Osteoporosis
RecruitingObservational study
Assessment and Comparison of Osteoporosis Risk Factors After Stroke
Stroke, Osteoporosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Santiago Palacios study director
Instituto Palacios de la Salud de la Mujer. Presidente FHOEMO
Jose Luis Neyro study director
Hospital Universitario Cruces. Embajador FHOEMO
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoporosis, run by STADA, Spain at 10 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness for patients treatment with original (time frame: 24 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2022.