| Title |
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
|
|---|---|
| Published in |
Clinical Epidemiology, July 2016
|
| DOI | 10.2147/clep.s107270 |
| Pubmed ID | |
| Authors |
John Acquavella, Vera Ehrenstein, Morten Schiødt, Uffe Heide-Jørgensen, Anders Kjellman, Svein Hansen, Cecilia Larsson Wexell, Bente Brokstad Herlofson, Sven Erik Noerholt, Haijun Ma, Katarina Öhrling, Rohini K Hernandez, Henrik Toft Sørensen |
| Abstract |
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. 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-naïve patients, zoledronic acid-naïve 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(®) clinical trials program. 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. |
X Demographics
The data shown below were collected from the profile of 1 X user who shared this research output. Click here to find out more about how the information was compiled.
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| Unknown | 1 | 100% |
Demographic breakdown
| Type | Count | As % |
|---|---|---|
| Practitioners (doctors, other healthcare professionals) | 1 | 100% |
Mendeley readers
The data shown below were compiled from readership statistics for 22 Mendeley readers of this research output. Click here to see the associated Mendeley record.
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| Unknown | 22 | 100% |
Demographic breakdown
| Readers by professional status | Count | As % |
|---|---|---|
| Other | 3 | 14% |
| Student > Bachelor | 2 | 9% |
| Student > Postgraduate | 2 | 9% |
| Student > Master | 2 | 9% |
| Professor | 1 | 5% |
| Other | 3 | 14% |
| Unknown | 9 | 41% |
| Readers by discipline | Count | As % |
|---|---|---|
| Medicine and Dentistry | 6 | 27% |
| Veterinary Science and Veterinary Medicine | 1 | 5% |
| Pharmacology, Toxicology and Pharmaceutical Science | 1 | 5% |
| Philosophy | 1 | 5% |
| Decision Sciences | 1 | 5% |
| Other | 1 | 5% |
| Unknown | 11 | 50% |
Attention Score in Context
This research output has an Altmetric Attention Score of 1. This is our high-level measure of the quality and quantity of online attention that it has received. This Attention Score, as well as the ranking and number of research outputs shown below, was calculated when the research output was last mentioned on 21 July 2016.
All research outputs
#18,466,238
of 22,881,154 outputs
Outputs from Clinical Epidemiology
#569
of 720 outputs
Outputs of similar age
#267,498
of 351,890 outputs
Outputs of similar age from Clinical Epidemiology
#10
of 16 outputs
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