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Design and methods ...
Design and methods for a Scandinavian pharmacovigilance study of osteonecrosis of the jaw and serious infections among cancer patients treated with antiresorptive agents for the prevention of skeletal-related events
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Acquavella, J. (författare)
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Ehrenstein, V. (författare)
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Schiodt, M. (författare)
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Heide-Jorgensen, U. (författare)
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- Kjellman, A. (författare)
- Karolinska Institutet
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Hansen, S. (författare)
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- Larsson Wexell, Cecilia, 1965 (författare)
- Gothenburg University,Göteborgs universitet,Institutionen för kliniska vetenskaper, Avdelningen för biomaterialvetenskap,Institute of Clinical Sciences, Department of Biomaterials
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Herlofson, B. B. (författare)
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Noerholt, S. E. (författare)
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Ma, H. J. (författare)
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Öhrling, K. (författare)
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Hernandez, R. K. (författare)
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Sorensen, H. T. (författare)
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(creator_code:org_t)
- 2016
- 2016
- Engelska.
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Ingår i: Clinical Epidemiology. - 1179-1349. ; 8, s. 267-272
- Relaterad länk:
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https://gup.ub.gu.se...
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https://doi.org/10.2...
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http://kipublication...
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Abstract
Ämnesord
Stäng
- Objective: Osteonecrosis of the jaw (ONJ) is a recognized complication of potent antiresorptive therapies, especially at the doses indicated to prevent skeletal complications for cancer patients with bone metastases. This paper describes the rationale and methods for a prospective, post-authorization safety study of cancer patients treated with antiresorptive therapies. Methods: As part of a comprehensive pharmacovigilance plan, developed with regulators' input, the study will estimate incidence of ONJ and of serious infections among adult cancer patients with bone metastases treated with denosumab (120 mg subcutaneously) or zoledronic acid (4 mg intravenously, adjusted for renal function). Patients will be identified using routinely collected data combined with medical chart review in Denmark, Sweden, and Norway. Followup will extend from the first administration of antiresorptive treatment to the earliest of death, loss-to-follow-up, or 5 years after therapy initiation. Results will be reported for three treatment cohorts: denosumab-naive patients, zoledronic acid-naive patients, and patients who switch from bisphosphonate treatment to denosumab. ONJ cases will be identified in three newly established national ONJ databases and adjudicated by the committee that functioned during the XGEVA (R) clinical trials program. Conclusion: This study will provide a real world counterpart to the clinical trial-estimated risks for ONJ and serious infections for cancer patients initiating denosumab or zoledronic acid. The establishment of ONJ databases in the three Scandinavian countries will have potential benefits outside this study for the elucidation of ONJ risk factors and the evaluation of ONJ treatment strategies.
Ämnesord
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine (hsv//eng)
Nyckelord
- cohort study
- osteonecrosis of the jaw
- pharmacovigilance
- postmarketing drug surveillance
- denosumab
- zoledronic acid
- danish national registry
- surgeons position paper
- bone metastases
- american association
- prostate-cancer
- breast-cancer
- outcomes
- risk
- denosumab
- disease
- Public
- Environmental & Occupational Health
Publikations- och innehållstyp
- ref (ämneskategori)
- art (ämneskategori)
Hitta via bibliotek
Till lärosätets databas
- Av författaren/redakt...
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Acquavella, J.
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Ehrenstein, V.
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Schiodt, M.
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Heide-Jorgensen, ...
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Kjellman, A.
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Hansen, S.
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visa fler...
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Larsson Wexell, ...
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Herlofson, B. B.
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Noerholt, S. E.
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Ma, H. J.
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Öhrling, K.
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Hernandez, R. K.
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Sorensen, H. T.
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visa färre...
- Om ämnet
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- MEDICIN OCH HÄLSOVETENSKAP
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MEDICIN OCH HÄLS ...
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och Klinisk medicin
- Artiklar i publikationen
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Clinical Epidemi ...
- Av lärosätet
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Göteborgs universitet
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Karolinska Institutet