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Design and methods of a postmarketing pharmacoepidemiology study assessing long-term safety of Prolia® (denosumab) for the treatment of postmenopausal osteoporosis.

Xue F, Ma H, Stehman-Breen C, Haller C, Katz L, Wagman RB, Critchlow CW, Denosumab Global Safety Assessment Te - Pharmacoepidemiol Drug Saf (2013)

Bottom Line: Nine adverse events (AEs) will be assessed based on diagnosis codes: osteonecrosis of the jaw (ONJ), atypical femoral fracture (AFF), fracture healing complications, hypocalcemia, infection, dermatologic AEs, acute pancreatitis, hypersensitivity, and new primary malignancy.This study is based on comprehensive preliminary research and considers methodological challenges specific to the study population.The integrated data systems used in this regulatory committed program can serve as a powerful data resource to assess diverse and rare AEs over time.

View Article: PubMed Central - PubMed

Affiliation: Center for Observational Research, Amgen Inc., Thousand Oaks, CA, USA.

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Related in: MedlinePlus

Example of the classification of time at risk based on the on-treatment and post-treatment period for a patient receiving one dose of a bisphosphonate before receiving one dose of Prolia®
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fig01: Example of the classification of time at risk based on the on-treatment and post-treatment period for a patient receiving one dose of a bisphosphonate before receiving one dose of Prolia®

Mentions: Time at risk for specific AEs within exposure cohorts will be defined based on putative relationships between Prolia® and/or bisphosphonate exposure and specific AEs. Time at risk will be defined as the on-treatment period for some AEs and as the on-treatment plus post-treatment period for other AEs. Post-treatment period lengths are based on an etiologically relevant period for the specific exposure and AE. Figure 1 shows an example of classification of time at risk for a patient receiving one bisphosphonate dose before one Prolia® dose.


Design and methods of a postmarketing pharmacoepidemiology study assessing long-term safety of Prolia® (denosumab) for the treatment of postmenopausal osteoporosis.

Xue F, Ma H, Stehman-Breen C, Haller C, Katz L, Wagman RB, Critchlow CW, Denosumab Global Safety Assessment Te - Pharmacoepidemiol Drug Saf (2013)

Example of the classification of time at risk based on the on-treatment and post-treatment period for a patient receiving one dose of a bisphosphonate before receiving one dose of Prolia®
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4230463&req=5

fig01: Example of the classification of time at risk based on the on-treatment and post-treatment period for a patient receiving one dose of a bisphosphonate before receiving one dose of Prolia®
Mentions: Time at risk for specific AEs within exposure cohorts will be defined based on putative relationships between Prolia® and/or bisphosphonate exposure and specific AEs. Time at risk will be defined as the on-treatment period for some AEs and as the on-treatment plus post-treatment period for other AEs. Post-treatment period lengths are based on an etiologically relevant period for the specific exposure and AE. Figure 1 shows an example of classification of time at risk for a patient receiving one bisphosphonate dose before one Prolia® dose.

Bottom Line: Nine adverse events (AEs) will be assessed based on diagnosis codes: osteonecrosis of the jaw (ONJ), atypical femoral fracture (AFF), fracture healing complications, hypocalcemia, infection, dermatologic AEs, acute pancreatitis, hypersensitivity, and new primary malignancy.This study is based on comprehensive preliminary research and considers methodological challenges specific to the study population.The integrated data systems used in this regulatory committed program can serve as a powerful data resource to assess diverse and rare AEs over time.

View Article: PubMed Central - PubMed

Affiliation: Center for Observational Research, Amgen Inc., Thousand Oaks, CA, USA.

Show MeSH
Related in: MedlinePlus