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Prospective Observational Study to Describe Characteristics and Management of Patients Treated With Denosumab (Prolia®) in Routine Clinical Practice

4 de marzo de 2019 actualizado por: Amgen

Prospective Observational Study to Describe Characteristics and Management of Patients With Postmenopausal Osteoporosis Treated With Prolia® in Routine Clinical Practice

The objective of this prospective, observational study in Czech Republic and Slovakia is to describe per country the characteristics of women treated with denosumab in routine clinical practice and the clinical management of these patients during the first 2 years of treatment. In addition, the study aims to collect safety data in the real-life clinical practice settings on adverse drug reactions (ADRs) and serious ADRs.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Tipo de estudio

De observación

Inscripción (Actual)

600

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Chequia
      • Brno, Chequia, 602 00
        • Research Site
      • Brno, Chequia, 638 00
        • Research Site
      • Ceske Budejovice, Chequia, 370 01
        • Research Site
      • Havlickuv Brod, Chequia, 580 22
        • Research Site
      • Karlovy Vary, Chequia, 367 17
        • Research Site
      • Kutna Hora, Chequia, 284 01
        • Research Site
      • Ostrava, Chequia, 702 00
        • Research Site
      • Ostrava-Trebovice, Chequia, 722 00
        • Research Site
      • Plzen, Chequia, 323 00
        • Research Site
      • Praha 11, Chequia, 148 00
        • Research Site
      • Praha 2, Chequia, 128 50
        • Research Site
      • Praha 4 - Nusle, Chequia, 140 00
        • Research Site
      • Trutnov, Chequia, 541 21
        • Research Site
      • Vsetin, Chequia, 755 01
        • Research Site
      • Zlin, Chequia, 760 01
        • Research Site
      • Zlin, Chequia
        • Osteocentrum Zlin
  • Eslovaquia
      • Banska Bystrica, Eslovaquia, 974 01
        • Research Site
      • Bratislava, Eslovaquia, 826 06
        • Research Site
      • Bratislava, Eslovaquia, 833 05
        • Research Site
      • Humenne, Eslovaquia, 066 01
        • Research Site
      • Kosice, Eslovaquia, 040 01
        • Research Site
      • Kosice-Saca, Eslovaquia, 040 15
        • Research Site
      • Lubochna, Eslovaquia, 034 91
        • Research Site
      • Lucenec, Eslovaquia, 984 01
        • Research Site
      • Martin, Eslovaquia, 036 01
        • Research Site
      • Nitra, Eslovaquia, 949 01
        • Research Site
      • Presov, Eslovaquia, 080 01
        • Research Site
      • Trnava, Eslovaquia, 917 75
        • Research Site
      • Zilina, Eslovaquia, 010 01
        • Research Site

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Niño
  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Femenino

Método de muestreo

Muestra no probabilística

Población de estudio

The study was conducted at various study centers in the Czech Republic and Slovakia. Postmenopausal women with osteoporosis who receive an injection of denosumab and meet the inclusion/exclusion criteria will be eligible to participate in the study.

Descripción

Inclusion Criteria

  • Women with a clinical diagnosis of postmenopausal osteoporosis
  • Decision has been made to treat with denosumab 60 mg once every 6 months
  • Have received their first injection of denosumab within 8 weeks prior to enrolling in this study.
  • Appropriate written informed consent has been obtained (as required per local country regulations)

Exclusion Criteria

  • Participating in ongoing or have participated in previous denosumab clinical trials
  • Participation in other clinical or device trials in the last 6 months
  • Contra-indicated for treatment with Prolia® according to the approved applicable local product label.
  • Subject has any kind of disorder that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
Intervención / Tratamiento
Denosumab
Patients with postmenopausal osteoporosis (PMO) who received at least 1 injection of denosumab 60 mg subcutaneously in the Czech Republic and Slovakia.
Biológico: Denosumab
This is an non-interventional study, therefore denosumab is administered as part of routine care and not for purposes of the study.
Otros nombres:
  • Prolia®

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Number of Participants Receiving All Prescriptions and Injections of Denosumab From the Initial Prescribing Physician's Office
Periodo de tiempo: 24 months
Number of participants who received all injection(s), including baseline injection, from the initial prescribing site irrespective of total number of injections received on study.
24 months
Number of Participants Receiving an Individual Prescription and Injection of Denosumab From the Initial Prescribing Physician Office by Each Individual Injection
Periodo de tiempo: Baseline (day 1), and at Months 6, 12, 18 and 24 (corresponding to the first, second, third and fourth post-baseline injections respectively)
Baseline (day 1), and at Months 6, 12, 18 and 24 (corresponding to the first, second, third and fourth post-baseline injections respectively)
Number of Participants Receiving All Prescriptions and Injections of Denosumab
Periodo de tiempo: Months 6, 12, 18 and 24 (corresponding to the first, second, third and fourth post-baseline injections respectively)
Number of participants receiving all prescriptions and injections of denosumab whether or not the injections are given at the initial prescribing physician's office.
Months 6, 12, 18 and 24 (corresponding to the first, second, third and fourth post-baseline injections respectively)
Number of Participants With a Referral by the Prescribing Physician to Other Health Care Providers for Continuation or Follow-up of Care
Periodo de tiempo: 24 months
24 months
Types of Health Care Providers Administering an Individual Injection of Denosumab at the Baseline Injection
Periodo de tiempo: Baseline (day 1)
Types of health care providers administering an individual injection of denosumab inside or outside the initial prescribing office at the baseline injection.
Baseline (day 1)
Types of Health Care Providers Administering Denosumab at the First Post-baseline Injection
Periodo de tiempo: Month 6
Types of health care providers administering an individual injection of denosumab inside or outside the initial prescribing office at the first post-baseline injection.
Month 6
Types of Health Care Providers Administering Denosumab at the Second Post-baseline Injection
Periodo de tiempo: Month 12
Types of health care providers administering an individual injection of denosumab inside or outside the initial prescribing office at the second post-baseline injection.
Month 12
Types of Health Care Providers Administering Denosumab at the Third Post-baseline Injection
Periodo de tiempo: Month 18
Types of health care providers administering an individual injection of denosumab inside or outside the initial prescribing office at the third post-baseline injection.
Month 18
Types of Health Care Providers Administering Denosumab at the Fourth Post-baseline Injection
Periodo de tiempo: Month 24
Types of health care providers administering an individual injection of denosumab inside or outside the initial prescribing office at the fourth post-baseline injection.
Month 24
Number of Denosumab Post-baseline Injections Received by Each Participant
Periodo de tiempo: 24 months
24 months
Number of Participants Having Radiologic Bone Assessments
Periodo de tiempo: Pre-baseline (before first denosumab injection) and during the study (post-baseline)
Number of participants having radiologic bone assessments pre-treatment with denosumab and during the study.
Pre-baseline (before first denosumab injection) and during the study (post-baseline)
Number of Participants Having Osteoporosis Related Laboratory Examinations
Periodo de tiempo: Pre-baseline (before first denosumab injection) and post-baseline
Number of participants having osteoporosis related laboratory examinations pre-treatment with denosumab and during the study. Participants may not have been given denosumab injection when they attended each visit.
Pre-baseline (before first denosumab injection) and post-baseline

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Number of Participants With Adverse Drug Reactions (ADRs) to Denosumab
Periodo de tiempo: 24 months
Adverse events (AEs) that were considered related to denosumab as evaluated by the investigator were classified as adverse drug reactions (ADRs).
24 months
Number of Participants With Serious ADRs to Denosumab
Periodo de tiempo: 24 months
Serious adverse events that were considered related to denosumab were classified as serious adverse drug reactions (SADRs). A serious adverse event (SAE) is any AE that also: • is fatal • is life threatening (places the patient at immediate risk of death) • requires in-patient hospitalization or prolongation of existing hospitalization • results in persistent or significant disability/incapacity • is a congenital anomaly/birth defect • is an "other significant medical hazard" that does not meet any of the above criteria.
24 months

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Amgen

Colaboradores

One Amgen Center Drive
THOUSAND OAKS
CA
91320-1799
USA

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Enlaces Útiles

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

26 de junio de 2012

Finalización primaria (Actual)

15 de mayo de 2015

Finalización del estudio (Actual)

15 de mayo de 2015

Fechas de registro del estudio

Enviado por primera vez

26 de julio de 2012

Primero enviado que cumplió con los criterios de control de calidad

26 de julio de 2012

Publicado por primera vez (Estimar)

30 de julio de 2012

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

6 de marzo de 2019

Última actualización enviada que cumplió con los criterios de control de calidad

4 de marzo de 2019

Última verificación

1 de marzo de 2019

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 20110132

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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