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Bisphosphonates for osteoporosis in primary biliary cirrhosis

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Bisphosphonates for osteoporosis in primary biliary cirrhosis
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  Bisphosphonates for osteoporosis in primary biliary cirrhosis(Review) Rudic JS, Giljaca V, Krstic MN, Bjelakovic G, Gluud C This is a reprint of a Cochrane review, prepared and maintained by The Cochrane Collaboration and published in  TheCochrane Library  2011, Issue 12http://www.thecochranelibrary.com Bisphosphonates for osteoporosis in primary biliary cirrhosis (Review)Copyright © 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.  T A B L E O F C O N T E N T S 1HEADER . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1 ABSTRACT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2PLAIN LANGUAGE SUMMARY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3SUMMARY OF FINDINGS FOR THE MAIN COMPARISON . . . . . . . . . . . . . . . . . . .6BACKGROUND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7OBJECTIVES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7METHODS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10RESULTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Figure 1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11Figure 2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13Figure 3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14Figure 4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17Figure 5. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19Figure 6. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2021 ADDITIONAL SUMMARY OF FINDINGS . . . . . . . . . . . . . . . . . . . . . . . . . .25DISCUSSION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .27 AUTHORS’ CONCLUSIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .27 ACKNOWLEDGEMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .28REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .32CHARACTERISTICS OF STUDIES . . . . . . . . . . . . . . . . . . . . . . . . . . . . .43DATA AND ANALYSES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Analysis 1.1. Comparison 1 Bisphosphonates vs placebo or no intervention, Outcome 1 All-cause mortality. . . . 44 Analysis 1.2. Comparison 1 Bisphosphonates vs placebo or no intervention, Outcome 2 Fractures. . . . . . . . 45 Analysis 1.3. Comparison 1 Bisphosphonates vs placebo or no intervention, Outcome 3 Adverse advents. . . . . 46 Analysis 1.4. Comparison 1 Bisphosphonates vs placebo or no intervention, Outcome 4 Lumbar spine bone mineral density (g/cm²). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47 Analysis 1.5. Comparison 1 Bisphosphonates vs placebo or no intervention, Outcome 5 Proximal femur bone mineraldensity (g/cm 2 ). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48 Analysis 1.6. Comparison 1 Bisphosphonates vs placebo or no intervention, Outcome 6 Liver-related mortality or livertransplantation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49 Analysis 1.7. Comparison 1 Bisphosphonates vs placebo or no intervention, Outcome 7 Liver-related morbidity. . . 49 Analysis 1.8. Comparison 1 Bisphosphonates vs placebo or no intervention, Outcome 8 Serum osteocalcin (ng/ml). . 50 Analysis 1.9. Comparison 1 Bisphosphonates vs placebo or no intervention, Outcome 9 The urinary amino telopeptides of collagen I NTx (nmol bone collagen equivalents/mmol creatinine). . . . . . . . . . . . . . . . 51 Analysis 1.10. Comparison 1 Bisphosphonates vs placebo or no intervention, Outcome 10 Number of patients having bisphosphonates withdrawn due to adverse events. . . . . . . . . . . . . . . . . . . . . . 51 Analysis 2.1. Comparison 2 Bisphosphonates vs another bisphosphonate (alendronate vs etidronate or ibandronate),Outcome 1 All-cause mortality. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52 Analysis 2.2. Comparison 2 Bisphosphonates vs another bisphosphonate (alendronate vs etidronate or ibandronate),Outcome 2 Fractures. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52 Analysis 2.3. Comparison 2 Bisphosphonates vs another bisphosphonate (alendronate vs etidronate or ibandronate),Outcome 3 Adverse advents. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53 Analysis 2.4. Comparison 2 Bisphosphonates vs another bisphosphonate (alendronate vs etidronate or ibandronate),Outcome 4 Lumbar spine bone mineral density (g/cm²). . . . . . . . . . . . . . . . . . . . 53 Analysis 2.5. Comparison 2 Bisphosphonates vs another bisphosphonate (alendronate vs etidronate or ibandronate),Outcome 5 Proximal femur bone mineral density (g/cm 2 ). . . . . . . . . . . . . . . . . . . 54 Analysis 2.6. Comparison 2 Bisphosphonates vs another bisphosphonate (alendronate vs etidronate or ibandronate),Outcome 6 Liver-related mortality or liver transplantation. . . . . . . . . . . . . . . . . . . 55 Analysis 2.7. Comparison 2 Bisphosphonates vs another bisphosphonate (alendronate vs etidronate or ibandronate),Outcome 7 Liver-related morbidity. . . . . . . . . . . . . . . . . . . . . . . . . . . 55 iBisphosphonates for osteoporosis in primary biliary cirrhosis (Review)Copyright © 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.   Analysis 2.8. Comparison 2 Bisphosphonates vs another bisphosphonate (alendronate vs etidronate or ibandronate),Outcome 8 Serum osteocalcin (ng/ml). . . . . . . . . . . . . . . . . . . . . . . . . . 56 Analysis 2.9. Comparison 2 Bisphosphonates vs another bisphosphonate (alendronate vs etidronate or ibandronate),Outcome 9 The procollagen type I N-terminal propeptide (PINP) (ng/ml). . . . . . . . . . . . . 57 Analysis 2.10. Comparison 2 Bisphosphonates vs another bisphosphonate (alendronate vs etidronate or ibandronate),Outcome 10 The urinary amino telopeptides of collagen I (NTx) (nmol bone collagen equivalents /mmolcreatinine). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57 Analysis 2.11. Comparison 2 Bisphosphonates vs another bisphosphonate (alendronate vs etidronate or ibandronate),Outcome 11 Number of patients having alendronate withdrawn due to adverse events. . . . . . . . . 5858 ADDITIONAL TABLES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .59 APPENDICES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .62HISTORY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .62CONTRIBUTIONS OF AUTHORS . . . . . . . . . . . . . . . . . . . . . . . . . . . . .62DECLARATIONS OF INTEREST . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .62SOURCES OF SUPPORT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .62INDEX TERMS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . iiBisphosphonates for osteoporosis in primary biliary cirrhosis (Review)Copyright © 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.  [Intervention Review] Bisphosphonates for osteoporosis in primary biliary cirrhosis  Jelena S Rudic 1 , 2 , Vanja Giljaca  3 , Miodrag N Krstic 4 , Goran Bjelakovic 2 , 5 , Christian Gluud 21 Department of Hepatology, Clinic of Gastroenterology, Clinical Centre of Serbia, Belgrade, Serbia.  2 The Cochrane Hepato-Biliary Group, Copenhagen Trial Unit, Centre for Clinical Intervention Research, Department 3344, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.  3 Department of Gastroenterology, Clinical Hospital Centre Rijeka, Rijeka, Croatia.  4 Clinic of Gastroenterology, Clinical Centre of Serbia, Belgrade, Serbia.  5 Department of Internal Medicine, Medical Faculty, University of Nis,Nis, Serbia Contact address: Jelena S Rudic, jelena_rudic@yahoo.com. Editorial group:  Cochrane Hepato-Biliary Group. Publication status and date:  New, published in Issue 12, 2011. Review content assessed as up-to-date:  3 November 2011. Citation:  Rudic JS, Giljaca V, Krstic MN, Bjelakovic G, Gluud C. Bisphosphonates for osteoporosis in primary biliary cirrhosis. Cochrane Database of Systematic Reviews   2011, Issue 12. Art. No.: CD009144. DOI: 10.1002/14651858.CD009144.pub2.Copyright © 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. A B S T R A C T Background Bisphosphonates are widely used for treatment of postmenopausal osteoporosis. Patients with primary biliary cirrhosis often haveosteoporosis - either postmenopausal or secondary to the liver disease. No systematic review or meta-analysis has assessed the effects of bisphosphonates for osteoporosis in patients with primary biliary cirrhosis. Objectives To assess the beneficial and harmful effects of bisphosphonates for osteoporosis in primary biliary cirrhosis. Search methods The Cochrane Hepato-Biliary Group Controlled Trials Register, The Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library  , MEDLINE, EMBASE, Science Citation Index Expanded, LILACS, clinicaltrials.gov, the WHO InternationalClinicalTrialsRegistryPlatform , andfulltextsearcheswereconducteduntilNovember2011.Manufacturersandauthorswerecontactedfor additional studies during the conductance of the review. Selection criteria   All randomised clinical trials of bisphosphonates in primary biliary cirrhosis compared with placebo or no intervention, or anotherbisphosphonate, or any other drug. Data collection and analysis Two authors extracteddata. RevMan Analysiswas used for statistical analysis of dichotomous data with risk ratio (RR) or riskdifference(RD) and of continuous data with mean difference (MD) or standardised mean difference (SMD), all with 95% confidence intervals(CI). Methodological components were used to assess risk of systematic errors (bias). Trial sequential analysis was also used to controlfor random errors (play of chance). 1Bisphosphonates for osteoporosis in primary biliary cirrhosis (Review)Copyright © 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
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