User-only design to assess drug effectiveness in clinical practice: Application to bisphosphonates and secondary prevention of fractures

Pharmacoepidemiology and Drug Safety

Volumn 23, Issue 8, 2014, Pages 859-867

  Corrao, Giovanni ^a   Ghirardi, Arianna ^a   Segafredo, Giulia ^a   Zambon, Antonella ^a   Della Vedova, Gianluca ^a   Lapi, Francesco ^b,c,d   Cipriani, Francesco ^b   Caputi, Achille ^e   Vaccheri, Alberto ^f   Gregori, Dario ^g   Gesuita, Rosaria ^h   Vestri, Annarita ⁱ   Staniscia, Tommaso ^j   Mazzaglia, Giampiero ^b   Di Bari, Mauro ^k  

^a UNIVERSITY OF MILANO BICOCCA   (Italy)

^b Regional Agency for Healthcare Services of Tuscany   (Italy)

^c UNIVERSITY OF FLORENCE   (Italy)

^d MCGILL UNIVERSITY   (Canada)

^e UNIVERSITY OF MESSINA   (Italy)

^f UNIVERSITY OF BOLOGNA   (Italy)

^g UNIVERSITY OF TURIN   (Italy)

^h UNIVERSITÀ POLITECNICA DELLE MARCHE   (Italy)

ⁱ SAPIENZA UNIVERSITY OF ROME   (Italy)

^j UNIVERSITY OF CHIETI   (Italy)

^k CAREGGI UNIVERSITY HOSPITAL   (Italy)

more..

Author keywords

Bisphosphonates; Confounding; Fracture; Pharmacoepidemiology; Propensity score; User only design

Indexed keywords

ALENDRONIC ACID; ANTICOAGULANT AGENT; ANTIDEPRESSANT AGENT; CALCIUM; CORTICOSTEROID DERIVATIVE; GLUCOCORTICOID; HYPNOTIC AGENT; HYPOCHOLESTEROLEMIC AGENT; INSULIN; METFORMIN; NEUROLEPTIC AGENT; PROTON PUMP INHIBITOR; RALOXIFENE; RISEDRONIC ACID; SEDATIVE AGENT; SULFONYLUREA; VITAMIN D; BISPHOSPHONIC ACID DERIVATIVE; BONE DENSITY CONSERVATION AGENT;

ADULT; AGED; ARTICLE; CLINICAL PRACTICE; COHORT ANALYSIS; CONTROLLED STUDY; DRUG EFFICACY; FEMALE; FOLLOW UP; FRACTURE; HEALTH CARE UTILIZATION; HORMONE SUBSTITUTION; HOSPITAL PATIENT; HUMAN; MAJOR CLINICAL STUDY; MALE; META ANALYSIS (TOPIC); OBSERVATIONAL STUDY; PRESCRIPTION; PRIORITY JOURNAL; SECONDARY PREVENTION; CASE CONTROL STUDY; COMPARATIVE STUDY; EPIDEMIOLOGY; FACTUAL DATABASE; FRACTURES, BONE; HOSPITALIZATION; ITALY; METHODOLOGY; MIDDLE AGED; PROCEDURES; PROPENSITY SCORE; RETROSPECTIVE STUDY; STATISTICS AND NUMERICAL DATA; TIME; VERY ELDERLY;

AGED; AGED, 80 AND OVER; BONE DENSITY CONSERVATION AGENTS; CASE-CONTROL STUDIES; CONFOUNDING FACTORS (EPIDEMIOLOGY); DATABASES, FACTUAL; DIPHOSPHONATES; FEMALE; FRACTURES, BONE; HOSPITALIZATION; HUMANS; ITALY; MALE; MIDDLE AGED; OBSERVATIONAL STUDY AS TOPIC; PROPENSITY SCORE; RESEARCH DESIGN; RETROSPECTIVE STUDIES; SECONDARY PREVENTION; TIME FACTORS;

EID: 84905024983     PISSN: 10538569     EISSN: 10991557     Source Type: Journal    
DOI: 10.1002/pds.3650     Document Type: Article

References (33)

1. Walker AM. Confounding by indication. Epidemiology 1996; 7: 335-336.
2. Schneeweiss S, Patrick AR, Stürmer T, et al. Increasing levels of restriction in pharmacoepidemiologic database studies of elderly and comparison with randomized trial results. Med Care 2007; 45(suppl 2): S131-S142.
3. McMahon AD. Observation and experiment with the efficacy of drugs: a warning example from a cohort of nonsteroidal anti-inflammatory and ulcer-healing drug users. Am J Epidemiol 2001; 154: 557-562.
4. Austin PC. Balance diagnostics for comparing the distribution of baseline covariates between treatment groups in propensity-score matched samples. Stat Med 2009; 28: 3083-3107.
5. Brookhart MA, Stürmer T, Glynn RJ, Rassen J, Schneeweiss S. Confounding control in healthcare database research challenges and potential approaches. Med Care 2010; 48(suppl 1): S5-S8.
6. Brown JP, Josse RG, Scientific Advisory Council of the Osteoporosis Society of Canada. 2002 clinical practice guidelines for the diagnosis and management of osteoporosis in Canada. CMAJ 2002; 167(10 Suppl): S1-S34.
7. Lapi F, Cipriani F, Caputi AP, et al., on behalf of the Bisphosphonates Efficacy-Safety Tradeoff (BEST) study group. Assessing the risk of osteonecrosis of the jaw due to bisphosphonate therapy in the secondary prevention of osteoporotic fractures. Osteoporos Int 2013; 24: 697-705.
8. Federal Information Processing Standards. Secure Hash Standard (SHS). PUB 180-184;2000 (http://csrc.nist.gov/publications/drafts/fips180-4/Draft-FIPS180-4_[Feb2011].pdf).
9. Rosenbaum PR, Rubin DB. The central role of the propensity score in observational studies for causal effects. Biometrika 1983; 70: 41-55.
10. Rosenbaum PR, Rubin DB. Reducing bias in observational studies using subclassification on the propensity score. J Am Stat Assoc 1984; 79: 516-524.
11. Parsons LS. Reducing bias in a propensity score matched pair sample using greedy matching techniques. In Proceedings of the Twenty-Sixth Annual SAS Users Group International Conference. Cary: NC, 2004.
12. Chesnut CH, 3rd, McClung MR, Ensrud KE, et al. Alendronate treatment of the postmenopausal osteoporotic woman: effect of multiple dosages on bone mass and bone remodeling. Am J Med 1995; 99: 144-152.
13. Liberman UA, Weiss SR, Bröll J, et al. Effect of oral alendronate on bone mineral density and the incidence of fractures in postmenopausal osteoporosis The Alendronate Phase III Osteoporosis Treatment Study Group. N Engl J Med 1995; 333: 1437-1443.
14. Black DM, Cummings SR, Karpf DB, et al. Randomised trial of effect of alendronate on risk of fracture in women with existing vertebral fractures. Fracture Intervention Trial Research Group. Lancet 1996; 348: 1535-1541.
15. Bone HG, Downs RW, Jr, Tucci JR, et al. Dose-response relationships for alendronate treatment in osteoporotic elderly women. Alendronate Elderly Osteoporosis Study Centers. J Clin Endocrinol Metab 1997; 82: 265-274.
16. Greenspan SL, Parker RA, Ferguson L, Rosen HN, Maitland-Ramsey L, Karpf DB. Early changes in biochemical markers of bone turnover predict the long-term response to alendronate therapy in representative elderly women: a randomized clinical trial. J Bone Miner Res 1998; 13: 1431-1438.
17. Pols HA, Felsenberg D, Hanley DA, et al. Multinational, placebo controlled, randomized trial of the effects of alendronate on bone density and fracture risk in postmenopausal women with low bone mass: results of the FOSIT study. Fosamax International Trial Study Group. Osteoporos Int 1999; 9: 461-468.
18. Harris ST, Watts NB, Genant HK, et al. Effects of risedronate treatment on vertebral and nonvertebral fractures in women with postmenopausal osteoporosis: a randomized, controlled trial. JAMA 1999; 282: 1344-1352.
19. Reginster J, Minne HW, Sorensen OH, et al. Randomized trial of the effects of risedronate on vertebral fractures in women with established postmenopausal osteoporosis. Osteoporos Int 2000; 11: 83-91.
20. Fogelman I, Ribot C, Smith R, Ethgen D, Sod E, Reginster JY. Risedronate reverses bone loss in postmenopausal women with low bone mass: results from a multinational, double-blind, placebo-controlled trial. BMD-MN Study Group. J Clin Endocrinol Metab 2000; 85: 1895-90.
21. McClung MR, Geusens P, Miller PD, et al., for the Hip Intervention Program Study Group. Effect of risedronate on the risk of hip fracture in elderly women. N Engl J Med 2001; 344: 333-340.
22. Wells G, Cranney A, Peterson J, et al. Risedronate for the primary and secondary prevention of osteoporotic fractures in postmenopausal women. Cochrane Database Syst Rev 2008; (1): CD004523.
23. Wells GA, Cranney A, Peterson J, et al. Alendronate for the primary and secondary prevention of osteoporotic fractures in postmenopausal women. Cochrane Database Syst Rev 2008; (1): CD001155.
24. Black DM, Thompson DE, Bauer DC, et al., for the Fit Research Group. Fracture risk reduction with alendronate in women with osteoporosis: the fracture intervention trial. J Clin Endocrinol Metab 2000; 85: 4118-4124.
25. Harrington JT, Ste-Marie LG, Brandi ML, et al. Risedronate rapidly reduces the risk for nonvertebral fractures in women with postmenopausal osteoporosis. Calcif Tissue Int 2004; 74: 129-135.
26. Cramer JA, Goold DT, Silverman SL, Lewiecki EM. A systematic review of persistence and compliance with bisphosphonates for osteoporosis. Osteoporos Int 2007; 18: 1023-1031.
27. Cochrane A. Effectiveness and efficiency: random reflection on health services. Nuffiled Provincial Trust: London, 1972.
28. Compston J, Bowring C, Cooper A, et al. Diagnosis and management of osteoporosis in postmenopausal women and older men in the UK. National Osteoporosis Guideline Group: (NOGG) update 2013. Maturitas 2013; 75: 392-396.
29. Schneeweiss S. Developments in post-marketing comparative effectiveness research. Clin Pharmacol Ther 2007; 82: 143-156.
30. Perreault S, Dragomir A, Blais L, et al. Population-based study of the effectiveness of bone-specific drugs in reducing the risk of osteoporotic fracture. Pharmacoepidemiol Drug Saf 2008; 17: 248-259.
31. Andrade SE, Majumdar SR, Chan KA, et al. Low frequency of treatment of osteoporosis among postmenopausal women following a fracture. Arch Intern Med 2003; 163: 2052-2057.
32. Panneman MJ, Lips P, Sen SS, Herings RM. Undertreatment with anti-osteoporotic drugs after hospitalization for fracture. Osteoporos Int 2004; 15: 120-124.
33. Cramer JA, Gold DT, Silverman SL, Lewiecki EM. A systematic review of persistence and compliance with bisphosphonates for osteoporosis. Osteoporos Int 2007; 18: 1023-1031.