Clinical trial NCT05369013: Study and Follow-up of the Clinical Effectiveness and Comparative Safety of Biosimilar Teriparatide in the Management of Postmenopausal or Senile.
Official title: Study and Follow-up of the Clinical Effectiveness and Comparative Safety of Biosimilar Teriparatide in the Management of Postmenopausal or Senile (ESECTO)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Osteoporosis
Keywords: Osteoporosis
Risk fracture
Postmenopausical
Forsteo
Movymia
Lead sponsor: STADA, Spain
Sponsor class: OTHER
Collaborators: name: Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
name: Instituto Palacios
name: Complexo Hospitalario de Ourense
name: Hospital Universitario Central de Asturias
name: Parc Taulí Hospital Universitari
name: Hospital Universitario Fundación Jiménez Díaz
name: Hospital Universitario Infanta Leonor
name: Hospital Universitario Virgen Macarena
name: Hospital d´Igualada
name: Alpha Bioresearch S.L.
First posted: 2022-05-11
Enrollment: 188
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
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).

Brief 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.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Effectiveness for patients treatment with original
timeFrame: 24 Months
Secondary outcomes:
measure: Confirm fracture rate in any localization while study is ongoing
timeFrame: 30 Months
measure: Demographic and personal aspects related to the risk of osteoporosis
timeFrame: 24 Months
measure: Risk factor of osteoporosis
timeFrame: 30 Months
measure: Previous clinical data
timeFrame: 24 Months
measure: Anthropometric clinical data
timeFrame: 24 Months
measure: Osteoporosis diagnosis
timeFrame: 24 Months
measure: TBS
timeFrame: 24 Months
measure: FRAX
timeFrame: 24 Months
measure: Bone remodelling biomarkers
timeFrame: 24 Months
measure: Hepatic profile
timeFrame: 24 Months
measure: Previous bone fractures
timeFrame: 30 Months
measure: Previous treatment for osteoporosis
timeFrame: 24 Months
measure: Complementary previous treatment for osteoporosis
timeFrame: 24 Months
measure: Security profile
timeFrame: 30 Months
measure: Bone fractures during treatment
timeFrame: 24 Months
measure: Falls
timeFrame: 24 Months
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Parc Taulí
city: Barcelona
country: Spain
facility: Hospital Universitario Igualada
city: Madrid
country: Spain
facility: Hospital 12 de Octubre
city: Madrid
country: Spain
facility: Hospital de La Princesa
city: Madrid
country: Spain
facility: Hospital Fundación Jimenez Diaz
city: Madrid
country: Spain
facility: Hospital Infanta Leonor
city: Madrid
country: Spain
facility: Instituto Palacio de Madrid
city: Orense
country: Spain
facility: Complejo Hospitalario Universitario de Orense
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias
city: Sevilla
country: Spain
facility: Hospital Virgen Macarena
Study officials:
affiliation: Instituto Palacios de la Salud de la Mujer. Presidente FHOEMO
name: Santiago Palacios
role: STUDY_DIRECTOR
affiliation: Hospital Universitario Cruces. Embajador FHOEMO
name: Jose Luis Neyro
role: STUDY_DIRECTOR
References: