Oral bisphosphonates and risk of subtrochanteric or diaphyseal femur fractures in a population-based cohort

Journal of Bone and Mineral Research

Volumn 26, Issue 5, 2011, Pages 993-1001

  Kim, Seo Young ^a,c   Schneeweiss, Sebastian ^a,b   Katz, Jeffrey N ^a,b   Levin, Raisa ^a   Solomon, Daniel H ^a  

^a BRIGHAM AND WOMEN S HOSPITAL   (United States)

^b HARVARD SCHOOL OF PUBLIC HEALTH   (United States)

^c MSCE   (United States)

Author keywords

BISPHOSPHONATES; CALCITONIN; FEMORAL FRACTURES; OSTEOPOROSIS; RALOXIFENE; SIDE EFFECTS

Indexed keywords

ALENDRONIC ACID; ANTICONVULSIVE AGENT; BENZODIAZEPINE DERIVATIVE; CALCITONIN; ETIDRONIC ACID; OPIATE; PROTON PUMP INHIBITOR; RALOXIFENE; RISEDRONIC ACID; SEROTONIN UPTAKE INHIBITOR; STEROID; WARFARIN;

AGED; ARTICLE; COHORT ANALYSIS; DIAPHYSIS; FEMALE; FEMUR FRACTURE; FEMUR SUBTROCHANTERIC FRACTURE; HUMAN; INCIDENCE; MAJOR CLINICAL STUDY; MALE; OSTEOPOROSIS; POPULATION RESEARCH; RISK ASSESSMENT; TREATMENT DURATION;

ADMINISTRATION, ORAL; AGED; AGED, 80 AND OVER; BONE DENSITY CONSERVATION AGENTS; COHORT STUDIES; DIAPHYSES; DIPHOSPHONATES; FEMALE; FEMORAL FRACTURES; HIP FRACTURES; HUMANS; INCIDENCE; KAPLAN-MEIER ESTIMATE; OSTEOPOROSIS; PROPORTIONAL HAZARDS MODELS; RISK FACTORS;

EID: 79955575346     PISSN: 08840431     EISSN: None     Source Type: Journal    
DOI: 10.1002/jbmr.288     Document Type: Article

References (33)

1. Drake MT, Clarke BL, Khosla S., Bisphosphonates: mechanism of action and role in clinical practice. Mayo Clin Proc. 2008; 83: 1032-1045.
2. Guyatt G, Cranney A, Griffith L, et al. Summary of meta-analyses of therapies for postmenopausal osteoporosis and the relationship between bone density and fractures. Endocrinol Metab Clin North Am. 2002; 31: 659-679. (Pubitemid 35006615)
3. Kwek E, Koh J, Howe T., More on atypical fractures of the femoral diaphysis. N Engl J Med. 2008; 359: 316-317. (Pubitemid 352008464)
4. Lee P, Seibel M., More on atypical fractures of the femoral diaphysis. N Engl J Med. 2008; 359: 317. (Pubitemid 352008465)
5. Edwards M, McCrae F, Young-Min S., Alendronate-related femoral diaphysis fracture: what should be done to predict and prevent subsequent fracture of the contralateral side ? Osteoporos Int. 2010; 21: 701-703.
6. Lenart B, Lorich D, Lane J., Atypical fractures of the femoral diaphysis in postmenopausal women taking alendronate. N Engl J Med. 2008; 358: 1304-1306. (Pubitemid 351439247)
7. Capeci C, Tejwani N., Bilateral low-energy simultaneous or sequential femoral fractures in patients on long-term alendronate therapy. J Bone Joint Surg Am. 2009; 91: 2556-2561.
8. Odvina C, Zerwekh J, Rao D, Maalouf N, Gottschalk F, Pak C., Severely suppressed bone turnover: a potential complication of alendronate therapy. J Clin Endocrinol Metab. 2005; 90: 1294-1301. (Pubitemid 40463979)
9. Ing-Lorenzini K, Desmeules J, Plachta O, Suva D, Dayer P, Peter R., Low-energy femoral fractures associated with the long-term use of bisphosphonates: a case series from a Swiss university hospital. Drug Saf. 2009; 32: 775-785.
10. Neviaser A, Lane J, Lenart B, Edobor-Osula F, Lorich D., Low-energy femoral shaft fractures associated with alendronate use. J Orthop Trauma. 2008; 22: 346-350. (Pubitemid 351630250)
11. Schilcher J, Aspenberg P., Incidence of stress fractures of the femoral shaft in women treated with bisphosphonate. Acta Orthopaedica. 2009; 80: 413-415.
12. Armamento-Villareal R, Napoli N, Diemer K, et al. Bone turnover in bone biopsies of patients with low-energy cortical fractures receiving bisphosphonates: a case series. Calcif Tissue Int. 2009; 85: 37-44.
13. Watts N, Diab D., Long-term use of bisphosphosphonates in osteoporosis. J Clin Endocrinol Metab. 2010; 95: 1555-1565.
14. Abrahamsen B, Eiken P, Eastell R., Subtrochanteric and diaphyseal femur fractures in patients treated with alendronate: a register-based national cohort study. J Bone Miner Res. 2009; 24: 1095-1102.
15. Csizmadi I, Collet J-P., Bias and confounding in pharmacoepidemiology. In:, Strom B, Kimmel S, eds. Textbook of Pharmacoepidemiology. Chichester, UK: John Wiley & Sons, Ltd, 2006: pp 167-171.
16. Schneeweiss S, Patrick A, Stürmer T, et al. Increasing levels of restriction in pharmacoepidemiologic database studies of elderly and comparison with randomized trial results. Med Care. 2007; 45 (10 Supl 2): S131-142.
17. Schneeweiss S., A basic study design for expedited safety signal evaluation based on electronic healthcare data. Pharmacoepidemiol Drug Saf. 2010; 19: 858-868.
18. D'Agostino RJ., Propensity score methods for bias reduction in the comparison of a treatment to a non-randomized control group. Stat Med. 1998; 17: 2265-2281.
19. Black D, Kelly M, Genant H, et al. Bisphosphonates and fractures of the subtrochanteric or diaphyseal femur. N Engl J Med. 2010; 362: 1761-1771.
20. FDA. FDA Drug Safety Communication: Ongoing safety review of oral bisphosphonates and atypical subtrochanteric femur fractures, 3/10/2010 ed. 2010.
21. Ray W., Evaluating medication effects outside of clinical trials: new-user designs. Am J Epidemiol. 2003; 158: 915-920. (Pubitemid 37323253)
22. Rubin D., Estimating causal effects from large data sets using propensity scores. Ann Intern Med. 1997; 127 (8 Pt 2): 757-763. (Pubitemid 27446562)
23. Narongroeknawin P, Patkar N, Shakoory B, et al. Identification of subtrochanteric and diaphyseal femoral fractures using administrative claims data. Ann Rheum Dis. 2010; 69 (Suppl 3): 646.
24. Miyamoto R, Kaplan K, Levine B, Egol K, Zuckerman J., Surgical management of hip fractures: an evidence-based review of the literature. I: femoral neck fractures. J Am Acad Orthop Surg. 2008; 16: 596-607.
25. Deyo R, Cherkin D, Ciol M., Adapting a clinical comorbidity index for use with ICD-9-CM administrative databases. J Clin Epidemiol. 1992; 45: 613-619.
26. Schneeweiss S, Seeger J, Maclure M, Wang P, Avorn J, Glynn R., Performance of comorbidity scores to control for confounding in epidemiologic studies using claims data. Am J Epidemiol. 2001; 154: 854-864. (Pubitemid 33000813)
27. Lin D, Wei L, Ying Z., Checking the Cox model with cumulative sums of martingale-based residuals. Biometrika. 1993; 80: 557-572.
28. Solomon D, Rekedal L, Cadarette S., Osteoporosis treatments and adverse events. Curr Opin Rheumatol. 2009; 21: 363-368.
29. Goodman S, Berlin J., The use of predicted confidence intervals when planning experiments and the misuse of power when interpreting results. Ann Intern Med. 1994; 121: 200-206. (Pubitemid 24225638)
30. Nieves J, Bilezikian J, Lane J, et al. Fragility fractures of the hip and femur: incidence and patient characteristics. Osteoporos Int. 2009; 21: 399-408.
31. Freiman J, Chalmers T, Smith HJ, Kuebler R., The importance of beta, the type II error and sample size in the design and interpretation of the randomized control trial. Survey of 71 "negative" trials. N Engl J Med. 1978; 299: 690-694. (Pubitemid 9053296)
32. Cummings S, Black D, Thompson D, et al. Effect of alendronate on risk of fracture in women with low bone density but without vertebral fractures: results from the Fracture Intervention Trial. JAMA. 1998; 280: 2077-2082. (Pubitemid 29014065)
33. Strom B., Overview of automated databases in pharmacoepidemiology. In:, Strom B, Kimmel S, eds. Textbook of Pharmacoepidemiology. John Wiley & Sons, Ltd, 2006: pp 167-171.