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

Pharmacoepidemiology and Drug Safety

Volumn 22, Issue 10, 2013, Pages 1107-1114

  Xue, Fei ^a   Ma, Haijun ^a   Stehman Breen, Catherine ^a   Haller, Christine ^a   Katz, Leonid ^a   Wagman, Rachel B ^a   Critchlow, Cathy W ^a   Delzell, Elizabeth ^b   Curtis, Jeffrey R ^b   Dore, David ^c   Wang, Florence ^c   Sorensen, Henrik Toft ^d   Pedersen, Lars ^d   Ehrenstein, Vera ^d  

^a AMGEN INC   (United States)

^b UNIVERSITY OF ALABAMA AT BIRMINGHAM   (United States)

^c OPTUM   (United States)

^d AARHUS UNIVERSITY   (Denmark)

Author keywords

Database; Pharmacoepidemiology; Pharmacoepidemiology methods; Pharmacovigilance; Postmarketing drug safety; Postmenopausal osteoporosis; Prolia (denosumab)

Indexed keywords

ALENDRONIC ACID; BISPHOSPHONIC ACID DERIVATIVE; DENOSUMAB; ETIDRONIC ACID; IBANDRONIC ACID; RISEDRONIC ACID; ZOLEDRONIC ACID;

ACUTE PANCREATITIS; AGED; ARTICLE; DRUG EXPOSURE; DRUG HYPERSENSITIVITY; DRUG MARKETING; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; FEMALE; FEMUR FRACTURE; FOLLOW UP; FRACTURE HEALING; FRAGILITY FRACTURE; HUMAN; HYPOCALCEMIA; INCIDENCE; INFECTION; JAW OSTEONECROSIS; LONG TERM CARE; MAJOR CLINICAL STUDY; MEDICARE; OPEN STUDY; PHARMACOEPIDEMIOLOGY; POSTMENOPAUSE OSTEOPOROSIS; PRIMARY TUMOR; PRIORITY JOURNAL; PROSPECTIVE STUDY;

DATABASE; PHARMACOEPIDEMIOLOGY; PHARMACOEPIDEMIOLOGY METHODS; PHARMACOVIGILANCE; POSTMARKETING DRUG SAFETY; POSTMENOPAUSAL OSTEOPOROSIS; PROLIA® (DENOSUMAB);

AGED; ANTIBODIES, MONOCLONAL, HUMANIZED; BONE DENSITY CONSERVATION AGENTS; COHORT STUDIES; DENMARK; FEMALE; FOLLOW-UP STUDIES; HUMANS; MIDDLE AGED; OSTEOPOROSIS, POSTMENOPAUSAL; RISK FACTORS; SAFETY; TREATMENT OUTCOME; UNITED STATES;

EID: 84884988518     PISSN: 10538569     EISSN: 10991557     Source Type: Journal    
DOI: 10.1002/pds.3477     Document Type: Article

References (25)

1. National Osteoporosis Foundation. Clinician's Guide to Prevention and Treatment of Osteoporosis. National Osteoporosis Foundation: Washington, DC, 2010.
2. NIH Consensus Development Panel on Osteoporosis Prevention. Diagnosis, and Therapy, March 7-29, 2000: highlights of the conference. South Med J 2001; 94(6): 569-573.
3. Reginster JY, Burlet N. Osteoporosis: a still increasing prevalence. Bone 2006; 38(2S1): S4-S9.
4. Boyle WJ, Simonet WS, Lacey DL. Osteoclast differentiation and activation. Nature 2003; 423(6937): 337-342.
5. Trefis Team. UnitedHealth Group is worth $70 on health insurance enrollments growth. Forbes 2010 http://www.forbes.com/sites/greatspeculations/2012/10/29/unitedhealth-group-is-worth-70-on-health-insurance-enrollments-growth/' (last accessed 10/01/2013).
6. Lix LM, Yogendran MS, Leslie WD, et al. Using multiple data features improved the validity of osteoporosis case ascertainment from administrative databases. J Clin Epidemiol 2008; 61(12): 1250-1260.
7. Neviaser AS, Lane JM, Lenart BA, Edobor-Osula F, Lorich DG. Low-energy femoral shaft fractures associated with alendronate use. J Orthop Trauma 2008; 22(5): 346-350.
8. Tennis P, Zavras A, Laskarides C, Tan H. Predictive value of ICD and CPT codes for identifying osteonecrosis of the jaw (ONJ). Pharmacoepidemiol Drug Saf 2009; 18(S1): S153-S154.
9. Narongroeknawin P, Patkar NM, Shakoory B, et al. Validation of diagnostic codes for subtrochanteric, diaphyseal, and atypical femoral fractures using administrative claims data. J Clin Densitom 2012; 15(1): 92-102.
10. Patkar NM, Curtis JR, Teng GG, et al. Administrative codes combined with medical records based criteria accurately identified bacterial infections among rheumatoid arthritis patients. J Clin Epidemiol 2009; 62(3): 321-327.
11. Schneeweiss S, Robicsek A, Scranton R, Zuckerman D, Solomon DH. Veteran's affairs hospital discharge databases coded serious bacterial infections accurately. J Clin Epidemiol 2007; 60(4): 397-409.
12. Thomsen RW, Schoonen WM, Farkas DK, et al. Risk for hospital contact with infection in patients with splenectomy: a population-based cohort study. Ann Intern Med 2009; 151(8): 546-555.
13. Chan HL, Stern RS, Arndt KA, et al. The incidence of erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis. A population-based study with particular reference to reactions caused by drugs among outpatients. Arch Dermatol 1990; 126(1): 43-47.
14. Strom BL, Carson JL, Halpern AC, et al. Using a claims database to investigate drug-induced Stevens-Johnson syndrome. Stat Med 1991; 10(4): 565-576.
15. Johannes CB, Ziyadeh N, Seeger JD, et al. Incidence of allergic reactions associated with antibacterial use in a large, managed care organisation. Drug Saf 2007; 30(8): 705-713.
16. Brackley ME, Penning MJ, Lesperance ML. In the absence of cancer registry data, is it sensible to assess incidence using hospital separation records? Int J Equity Health 2006; 5: 12.
17. Setoguchi S, Glynn RJ, Avorn J, Mogun H, Schneeweiss S. Statins and the risk of lung, breast, and colorectal cancer in the elderly. Circulation 2007; 115(1): 27-33.
18. Dore DD, Seeger JD, Arnold Chan K. Use of a claims-based active drug safety surveillance system to assess the risk of acute pancreatitis with exenatide or sitagliptin compared to metformin or glyburide. Curr Med Res Opin 2009; 25(4): 1019-1027.
19. Eland IA, Sturkenboom MJ, Wilson JH, Stricker BH. Incidence and mortality of acute pancreatitis between 1985 and 1995. Scand J Gastroenterol 2000; 35(10): 1110-1116.
20. Floyd A, Pedersen L, Nielsen GL, Thorladcius-Ussing O, Sorensen HT. Secular trends in incidence and 30-day case fatality of acute pancreatitis in North Jutland County, Denmark: a register-based study from 1981-2000. Scand J Gastroenterol 2002; 37(12): 1461-1465.
21. Feldstein A, Elmer PJ, Orwoll E, Herson M, Hillier T. Bone mineral density measurement and treatment for osteoporosis in older individuals with fractures: a gap in evidence-based practice guideline implementation. Arch Intern Med 2003; 163(18): 2165-2172.
22. Feldstein AC, Nichols GA, Elmer PJ, et al. Older women with fractures: patients falling through the cracks of guideline-recommended osteoporosis screening and treatment. J Bone Joint Surg Am 2003; 85-A(12): 2294-2302.
23. Agresti A 1990 Categorical Data Analysis. Wiley: New York.
24. Sambrook P, Olver I, Goss A. Bisphosphonates and osteonecrosis of the jaw. Aust Fam Physician 2006; 35(10): 801-803.
25. Ray WA. Evaluating medication effects outside of clinical trials: new-user designs. Am J Epidemiol 2003; 158(9): 915-920.