Prospective Observational Study to Describe Characteristics and Management of Patients Treated With Denosumab (Prolia®) in Routine Clinical Practice
4 mars 2019 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Observationell
Inskrivning (Faktisk)
600
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Banska Bystrica, Slovakien, 974 01
- Research Site
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Bratislava, Slovakien, 826 06
- Research Site
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Bratislava, Slovakien, 833 05
- Research Site
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Humenne, Slovakien, 066 01
- Research Site
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Kosice, Slovakien, 040 01
- Research Site
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Kosice-Saca, Slovakien, 040 15
- Research Site
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Lubochna, Slovakien, 034 91
- Research Site
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Lucenec, Slovakien, 984 01
- Research Site
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Martin, Slovakien, 036 01
- Research Site
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Nitra, Slovakien, 949 01
- Research Site
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Presov, Slovakien, 080 01
- Research Site
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Trnava, Slovakien, 917 75
- Research Site
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Zilina, Slovakien, 010 01
- Research Site
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Brno, Tjeckien, 602 00
- Research Site
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Brno, Tjeckien, 638 00
- Research Site
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Ceske Budejovice, Tjeckien, 370 01
- Research Site
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Havlickuv Brod, Tjeckien, 580 22
- Research Site
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Karlovy Vary, Tjeckien, 367 17
- Research Site
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Kutna Hora, Tjeckien, 284 01
- Research Site
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Ostrava, Tjeckien, 702 00
- Research Site
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Ostrava-Trebovice, Tjeckien, 722 00
- Research Site
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Plzen, Tjeckien, 323 00
- Research Site
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Praha 11, Tjeckien, 148 00
- Research Site
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Praha 2, Tjeckien, 128 50
- Research Site
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Praha 4 - Nusle, Tjeckien, 140 00
- Research Site
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Trutnov, Tjeckien, 541 21
- Research Site
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Vsetin, Tjeckien, 755 01
- Research Site
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Zlin, Tjeckien, 760 01
- Research Site
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Zlin, Tjeckien
- Osteocentrum Zlin
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Kvinna
Testmetod
Icke-sannolikhetsprov
Studera befolkning
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.
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
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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.
Andra namn:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Number of Participants Receiving All Prescriptions and Injections of Denosumab From the Initial Prescribing Physician's Office
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 24 months
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24 months
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Number of Participants Having Radiologic Bone Assessments
Tidsram: 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
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Number of Participants With Adverse Drug Reactions (ADRs) to Denosumab
Tidsram: 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
Tidsram: 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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Sponsor
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Användbara länkar
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
26 juni 2012
Primärt slutförande (Faktisk)
15 maj 2015
Avslutad studie (Faktisk)
15 maj 2015
Studieregistreringsdatum
Först inskickad
26 juli 2012
Först inskickad som uppfyllde QC-kriterierna
26 juli 2012
Första postat (Uppskatta)
30 juli 2012
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
6 mars 2019
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
4 mars 2019
Senast verifierad
1 mars 2019
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 20110132
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