Prospective Observational Study to Describe Characteristics and Management of Patients Treated With Denosumab (Prolia®) in Routine Clinical Practice
2019년 3월 4일 업데이트: 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.
연구 개요
연구 유형
관찰
등록 (실제)
600
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Banska Bystrica, 슬로바키아, 974 01
- Research Site
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Bratislava, 슬로바키아, 826 06
- Research Site
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Bratislava, 슬로바키아, 833 05
- Research Site
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Humenne, 슬로바키아, 066 01
- Research Site
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Kosice, 슬로바키아, 040 01
- Research Site
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Kosice-Saca, 슬로바키아, 040 15
- Research Site
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Lubochna, 슬로바키아, 034 91
- Research Site
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Lucenec, 슬로바키아, 984 01
- Research Site
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Martin, 슬로바키아, 036 01
- Research Site
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Nitra, 슬로바키아, 949 01
- Research Site
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Presov, 슬로바키아, 080 01
- Research Site
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Trnava, 슬로바키아, 917 75
- Research Site
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Zilina, 슬로바키아, 010 01
- Research Site
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Brno, 체코, 602 00
- Research Site
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Brno, 체코, 638 00
- Research Site
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Ceske Budejovice, 체코, 370 01
- Research Site
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Havlickuv Brod, 체코, 580 22
- Research Site
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Karlovy Vary, 체코, 367 17
- Research Site
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Kutna Hora, 체코, 284 01
- Research Site
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Ostrava, 체코, 702 00
- Research Site
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Ostrava-Trebovice, 체코, 722 00
- Research Site
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Plzen, 체코, 323 00
- Research Site
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Praha 11, 체코, 148 00
- Research Site
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Praha 2, 체코, 128 50
- Research Site
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Praha 4 - Nusle, 체코, 140 00
- Research Site
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Trutnov, 체코, 541 21
- Research Site
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Vsetin, 체코, 755 01
- Research Site
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Zlin, 체코, 760 01
- Research Site
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Zlin, 체코
- Osteocentrum Zlin
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
여성
샘플링 방법
비확률 샘플
연구 인구
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.
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
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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.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Number of Participants Receiving All Prescriptions and Injections of Denosumab From the Initial Prescribing Physician's Office
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 24 months
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24 months
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Number of Participants Having Radiologic Bone Assessments
기간: 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
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Number of Participants With Adverse Drug Reactions (ADRs) to Denosumab
기간: 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
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2012년 6월 26일
기본 완료 (실제)
2015년 5월 15일
연구 완료 (실제)
2015년 5월 15일
연구 등록 날짜
최초 제출
2012년 7월 26일
QC 기준을 충족하는 최초 제출
2012년 7월 26일
처음 게시됨 (추정)
2012년 7월 30일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2019년 3월 6일
QC 기준을 충족하는 마지막 업데이트 제출
2019년 3월 4일
마지막으로 확인됨
2019년 3월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .