PMID- 23857864
OWN - NLM
STAT- MEDLINE
DCOM- 20140502
LR  - 20211021
IS  - 1099-1557 (Electronic)
IS  - 1053-8569 (Print)
IS  - 1053-8569 (Linking)
VI  - 22
IP  - 10
DP  - 2013 Oct
TI  - Design and methods of a postmarketing pharmacoepidemiology study assessing 
      long-term safety of Prolia(R) (denosumab) for the treatment of postmenopausal 
      osteoporosis.
PG  - 1107-14
LID - 10.1002/pds.3477 [doi]
AB  - PURPOSE: To describe the rationale and methods for a prospective, open-cohort 
      study assessing the long-term safety of Prolia((R)) for treatment of postmenopausal 
      osteoporosis (PMO) in postmarketing settings. METHODS: Data will be derived from 
      United States Medicare, United Healthcare, and Nordic (Denmark, Sweden, Norway) 
      national registries. Observation will begin on the date of first Prolia((R)) 
      regulatory approval (May 26, 2010) and continue for 10 years. Women with PMO will 
      be identified by postmenopausal age, osteoporosis diagnosis, osteoporotic 
      fracture, or osteoporosis treatment. Exposure to Prolia((R)) and bisphosphonates 
      will be updated during follow-up; exposure cohorts will be defined based on 
      patient-years during which patients are on- or post-treatment. 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. Medical review will confirm selected potential cases 
      of ONJ and AFF. Incidence rates (IRs) of AEs will be described overall and for 
      exposure cohorts; multivariate Cox proportional hazard regression models will 
      compare IRs of AEs across exposure cohorts. Utilization patterns of Prolia((R)) for 
      approved, and unapproved indications will be described. CONCLUSION: 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.
CI  - (c) 2013 Amgen Inc. Pharmacoepidemiology and Drug Safety published by John Wiley & 
      Sons, Ltd.
FAU - Xue, Fei
AU  - Xue F
AD  - Center for Observational Research, Amgen Inc., Thousand Oaks, CA, USA.
FAU - Ma, Haijun
AU  - Ma H
FAU - Stehman-Breen, Catherine
AU  - Stehman-Breen C
FAU - Haller, Christine
AU  - Haller C
FAU - Katz, Leonid
AU  - Katz L
FAU - Wagman, Rachel B
AU  - Wagman RB
FAU - Critchlow, Cathy W
AU  - Critchlow CW
CN  - Denosumab Global Safety Assessment Team
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20130715
PL  - England
TA  - Pharmacoepidemiol Drug Saf
JT  - Pharmacoepidemiology and drug safety
JID - 9208369
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - 0 (Bone Density Conservation Agents)
RN  - 4EQZ6YO2HI (Denosumab)
SB  - IM
MH  - Aged
MH  - Antibodies, Monoclonal, Humanized/adverse effects/*therapeutic use
MH  - Bone Density Conservation Agents/adverse effects/therapeutic use
MH  - Cohort Studies
MH  - Denmark/epidemiology
MH  - Denosumab
MH  - Female
MH  - Follow-Up Studies
MH  - Humans
MH  - Middle Aged
MH  - Osteoporosis, Postmenopausal/*drug therapy/epidemiology
MH  - Risk Factors
MH  - Safety
MH  - Treatment Outcome
MH  - United States/epidemiology
PMC - PMC4230463
OTO - NOTNLM
OT  - Prolia(R) (denosumab)
OT  - database
OT  - pharmacoepidemiology
OT  - pharmacoepidemiology methods
OT  - pharmacovigilance
OT  - postmarketing drug safety
OT  - postmenopausal osteoporosis
EDAT- 2013/07/17 06:00
MHDA- 2014/05/03 06:00
PMCR- 2014/11/13
CRDT- 2013/07/17 06:00
PHST- 2012/07/20 00:00 [received]
PHST- 2013/05/24 00:00 [revised]
PHST- 2013/06/06 00:00 [accepted]
PHST- 2013/07/17 06:00 [entrez]
PHST- 2013/07/17 06:00 [pubmed]
PHST- 2014/05/03 06:00 [medline]
PHST- 2014/11/13 00:00 [pmc-release]
AID - 10.1002/pds.3477 [doi]
PST - ppublish
SO  - Pharmacoepidemiol Drug Saf. 2013 Oct;22(10):1107-14. doi: 10.1002/pds.3477. Epub 
      2013 Jul 15.