Prospective Observational Study to Describe Characteristics and Management of Patients Treated With Denosumab (Prolia®) in Routine Clinical Practice
4 mars 2019 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Type d'étude
Observationnel
Inscription (Réel)
600
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Banska Bystrica, Slovaquie, 974 01
- Research Site
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Bratislava, Slovaquie, 826 06
- Research Site
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Bratislava, Slovaquie, 833 05
- Research Site
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Humenne, Slovaquie, 066 01
- Research Site
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Kosice, Slovaquie, 040 01
- Research Site
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Kosice-Saca, Slovaquie, 040 15
- Research Site
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Lubochna, Slovaquie, 034 91
- Research Site
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Lucenec, Slovaquie, 984 01
- Research Site
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Martin, Slovaquie, 036 01
- Research Site
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Nitra, Slovaquie, 949 01
- Research Site
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Presov, Slovaquie, 080 01
- Research Site
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Trnava, Slovaquie, 917 75
- Research Site
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Zilina, Slovaquie, 010 01
- Research Site
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Brno, Tchéquie, 602 00
- Research Site
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Brno, Tchéquie, 638 00
- Research Site
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Ceske Budejovice, Tchéquie, 370 01
- Research Site
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Havlickuv Brod, Tchéquie, 580 22
- Research Site
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Karlovy Vary, Tchéquie, 367 17
- Research Site
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Kutna Hora, Tchéquie, 284 01
- Research Site
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Ostrava, Tchéquie, 702 00
- Research Site
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Ostrava-Trebovice, Tchéquie, 722 00
- Research Site
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Plzen, Tchéquie, 323 00
- Research Site
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Praha 11, Tchéquie, 148 00
- Research Site
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Praha 2, Tchéquie, 128 50
- Research Site
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Praha 4 - Nusle, Tchéquie, 140 00
- Research Site
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Trutnov, Tchéquie, 541 21
- Research Site
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Vsetin, Tchéquie, 755 01
- Research Site
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Zlin, Tchéquie, 760 01
- Research Site
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Zlin, Tchéquie
- Osteocentrum Zlin
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Femelle
Méthode d'échantillonnage
Échantillon non probabiliste
Population étudiée
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.
La description
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 d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
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Denosumab
Patients with postmenopausal osteoporosis (PMO) who received at least 1 injection of denosumab 60 mg subcutaneously in the Czech Republic and Slovakia.
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This is an non-interventional study, therefore denosumab is administered as part of routine care and not for purposes of the study.
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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Number of Participants Receiving All Prescriptions and Injections of Denosumab From the Initial Prescribing Physician's Office
Délai: 24 months
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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.
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24 months
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Number of Participants Receiving an Individual Prescription and Injection of Denosumab From the Initial Prescribing Physician Office by Each Individual Injection
Délai: Baseline (day 1), and at Months 6, 12, 18 and 24 (corresponding to the first, second, third and fourth post-baseline injections respectively)
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Baseline (day 1), and at Months 6, 12, 18 and 24 (corresponding to the first, second, third and fourth post-baseline injections respectively)
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Number of Participants Receiving All Prescriptions and Injections of Denosumab
Délai: Months 6, 12, 18 and 24 (corresponding to the first, second, third and fourth post-baseline injections respectively)
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Number of participants receiving all prescriptions and injections of denosumab whether or not the injections are given at the initial prescribing physician's office.
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Months 6, 12, 18 and 24 (corresponding to the first, second, third and fourth post-baseline injections respectively)
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Number of Participants With a Referral by the Prescribing Physician to Other Health Care Providers for Continuation or Follow-up of Care
Délai: 24 months
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24 months
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Types of Health Care Providers Administering an Individual Injection of Denosumab at the Baseline Injection
Délai: Baseline (day 1)
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Types of health care providers administering an individual injection of denosumab inside or outside the initial prescribing office at the baseline injection.
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Baseline (day 1)
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Types of Health Care Providers Administering Denosumab at the First Post-baseline Injection
Délai: Month 6
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Types of health care providers administering an individual injection of denosumab inside or outside the initial prescribing office at the first post-baseline injection.
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Month 6
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Types of Health Care Providers Administering Denosumab at the Second Post-baseline Injection
Délai: Month 12
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Types of health care providers administering an individual injection of denosumab inside or outside the initial prescribing office at the second post-baseline injection.
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Month 12
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Types of Health Care Providers Administering Denosumab at the Third Post-baseline Injection
Délai: Month 18
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Types of health care providers administering an individual injection of denosumab inside or outside the initial prescribing office at the third post-baseline injection.
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Month 18
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Types of Health Care Providers Administering Denosumab at the Fourth Post-baseline Injection
Délai: Month 24
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Types of health care providers administering an individual injection of denosumab inside or outside the initial prescribing office at the fourth post-baseline injection.
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Month 24
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Number of Denosumab Post-baseline Injections Received by Each Participant
Délai: 24 months
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24 months
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Number of Participants Having Radiologic Bone Assessments
Délai: Pre-baseline (before first denosumab injection) and during the study (post-baseline)
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Number of participants having radiologic bone assessments pre-treatment with denosumab and during the study.
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Pre-baseline (before first denosumab injection) and during the study (post-baseline)
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Number of Participants Having Osteoporosis Related Laboratory Examinations
Délai: Pre-baseline (before first denosumab injection) and post-baseline
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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.
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Pre-baseline (before first denosumab injection) and post-baseline
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
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Number of Participants With Adverse Drug Reactions (ADRs) to Denosumab
Délai: 24 months
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Adverse events (AEs) that were considered related to denosumab as evaluated by the investigator were classified as adverse drug reactions (ADRs).
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24 months
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Number of Participants With Serious ADRs to Denosumab
Délai: 24 months
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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.
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24 months
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Liens utiles
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
26 juin 2012
Achèvement primaire (Réel)
15 mai 2015
Achèvement de l'étude (Réel)
15 mai 2015
Dates d'inscription aux études
Première soumission
26 juillet 2012
Première soumission répondant aux critères de contrôle qualité
26 juillet 2012
Première publication (Estimation)
30 juillet 2012
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
6 mars 2019
Dernière mise à jour soumise répondant aux critères de contrôle qualité
4 mars 2019
Dernière vérification
1 mars 2019
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 20110132
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .