Osteoporosis International

, Volume 16, Issue 9, pp 1141–1149 | Cite as

Efficacy of risedronate administration in osteoporotic postmenopausal women affected by inflammatory bowel disease

  • Stefano Palomba
  • Francesco OrioJr.
  • Francesco Manguso
  • Angela Falbo
  • Tiziana Russo
  • Achille Tolino
  • Libuse Tauchmanovà
  • Annamaria Colao
  • Patrizia Doldo
  • Pasquale Mastrantonio
  • Fulvio Zullo
Original Article

Abstract

Patients with inflammatory bowel disease (IBD) have frequently a bone mineral density (BMD) significantly lower than age-matched healthy subjects. The low BMD observed in IBD patients is related also to a higher incidence of bone fractures. In this prospective randomized study we evaluated the effect of 1-year risedronate administration on bone mass and turnover, and on vertebral fractures in osteoporotic postmenopausal women with IBD in remission. Ninety osteoporotic postmenopausal women were randomized to receive oral risedronate 35 mg/week (risedronate group) or placebo tablets (placebo group; one tab/week). The duration of treatment was 12 months. At entry and after treatment, lumbar spine and hip BMD, and serum osteocalcin (OC) and urinary deoxypyridinoline/creatinine ratio (DPD-Cr) levels were evaluated. Vertebral fractures were assessed from thoracic and lumbar lateral and anterior-posterior spinal radiographs taken at baseline, and from lateral spinal radiographs taken at the end of the study. At study entry, no difference between groups was also detected in BMD and in bone turnover markers. At the end of the study, lumbar spine, trochanter and femoral neck BMD was significantly ( p <0.05) higher in comparison with baseline in the risedronate group, whereas a significant ( p <0.05) decrease was observed in the placebo group. For the same visit, a significant ( p <0.05) difference in lumbar spine, trochanter and femoral neck BMD was detected between groups. After 12-month follow-up, serum OC and urinary DPD-Cr levels were significantly ( p <0.05) lower and higher in comparison with basal values in risedronate and placebo group, respectively. At the same time, a significant ( p <0.05) difference in serum OC and urinary DPD-Cr levels was observed between groups. Throughout the study, the incidence of vertebral fractures was significantly ( p <0.05) lower in the risedronate group than in the placebo group (12.5% vs 34.1%). The relative risk (RR) to develop a new vertebral fracture after 1 year of risedronate administration was of 0.36 (95% confidence interval, 0.14–0.85). In conclusion, risedronate administration is an effective anti-osteoporotic treatment in osteoporotic postmenopausal women with IBD in remission.

Keywords

Bisphosphonates Clinical trials Menopause Osteoporosis Risedronate Treatments 

References

  1. 1.
    Seeman E (2002) Pathogenesis of bone fragility in women and man. Lancet 359:1841–1850CrossRefPubMedGoogle Scholar
  2. 2.
    Bischoff SC, Herrmann A, Goke M, Manns MP, von zur Muhlen A, Brabant G (1997) Altered bone metabolism in inflammatory bowel disease. Am J Gastroenterol 92:1157–1163PubMedGoogle Scholar
  3. 3.
    Vestergaard P (2003) Bone loss associated with gastrointestinal disease: prevalence and pathogenesis. Eur J Gastroenterol Hepatol 15:851–856PubMedGoogle Scholar
  4. 4.
    Lichetenstein GR (2003) Evaluation of bone mineral density in inflammatory bowel disease: current safety focus. Am J Gastroenterol 98:S24–30CrossRefGoogle Scholar
  5. 5.
    van Staa TP, Cooper C, Brusse LS, Leufkens H, Javaid MK, Arden NK (2003) Inflammatory bowel disease and the risk of fracture. Gastroenterology 125:1591–1597PubMedGoogle Scholar
  6. 6.
    Bernstein CN, Blanchard JF, Metge C, Yogendran M (2003) The association between corticosteroid use and development of fractures among IBD patients in a population-based database. Am J Gastroenterol 98:1797–1801PubMedGoogle Scholar
  7. 7.
    Klaus J, Armbrecht G, Steinkamp M, Bruckel J, Rieber A, Adler G, Reinshagen M, Felsenberg D, von Tirpitz C (2002) High prevalence of osteoporotic vertebral fractures in patients with Crohn’s disease. Gut 51:654–658PubMedGoogle Scholar
  8. 8.
    Card T, West J, Hubbard R, Logan RF (2004) Hip fractures in patients with inflammatory bowel disease and their relationship to corticosteroid use: a population-based cohort study. Gut 53:251–255PubMedGoogle Scholar
  9. 9.
    Nishimura J, Ikuyama S (2000) Glucocorticoid-induced osteoporosis: pathogenesis and management. J Bone Miner Metab 18:350–352PubMedGoogle Scholar
  10. 10.
    Compston J (2003) Glucocorticoid-induced osteoporosis. Horm Res 60 Suppl 3:77–79CrossRefGoogle Scholar
  11. 11.
    Boling EP (2004) Secondary osteoporosis: underlying disease and the risk for glucocorticoid-induced osteoporosis. Clin Ther 26:1–14PubMedGoogle Scholar
  12. 12.
    American College of Rheumatology Ad Hoc Committee on Glucocorticoid-Induced Osteoporosis (2001) Recommendations for the prevention and treatment of glucocorticoid-induced osteoporosis: 2001 Update. Arthritis Rheum 44:1496–1503PubMedGoogle Scholar
  13. 13.
    Valentine JF, Sninsky CA (1999) Prevention and treatment of osteoporosis in patients with inflammatory bowel disease. Am J Gastroenterol 94:878–883PubMedGoogle Scholar
  14. 14.
    National Institutes of Health Consensus Development Panel on Osteoporosis Prevention, Diagnosis, and Therapy (2001) Osteoporosis prevention, diagnosis, and therapy. JAMA 285:785–795PubMedGoogle Scholar
  15. 15.
    Altkorn D, Vokes T (2001) Treatment of postmenopausal osteoporosis. JAMA 285:1415–1418PubMedGoogle Scholar
  16. 16.
    Marcus R, Wong M, Heath H III, Stock JL (2002) Antiresorptive treatment of postmenopausal osteoporosis: comparison of study designs and outcomes in large clinical trials with fracture as an endpoint. Endocr Rev 23:16–37PubMedGoogle Scholar
  17. 17.
    Delmas PD (2002) Treatment of postmenopausal osteoporosis. Lancet 8:2018–2026CrossRefGoogle Scholar
  18. 18.
    Cranney A, Tugwell P, Adachi J, Weaver B, Zytaruk N, Papaioannou A, Robinson V, Shea B, Wells G, Guyatt G, Osteoporosis Methodology Group and The Osteoporosis Research Advisory Group (2002) Meta-analyses of therapies for postmenopausal osteoporosis. III. Meta-analysis of risedronate for the treatment of postmenopausal osteoporosis. Endocr Rev 23:517–523PubMedGoogle Scholar
  19. 19.
    Dunn CJ, Goa KL (2004) Risedronate: a review of its pharmacological properties and clinical use in resorptive bone disease. J Bone Miner Metab 22:111–119PubMedGoogle Scholar
  20. 20.
    Mantzaris GJ, Sfakianakis M, Archavlis E, Petraki K, Christidou A, Karagiannidis A, Triadaphyllou G (2004) A prospective randomized observer-blind 2-year trial of azathioprine monotherapy versus azathioprine and olsalazine for the maintenance of remission of steroid-dependent ulcerative colitis. Am J Gastroenterol 99:1122–1128PubMedGoogle Scholar
  21. 21.
    Hanauer SB, Sandborn W, Practice Parameters Committee of the American College of Gastroenterology (2001) Management of Crohn’s disease. Am J Gastroenterol 96:635–643PubMedGoogle Scholar
  22. 22.
    Palomba S, Orio F Jr, Di Carlo C, Colao A, Lombardi G, Zullo F, Mastrantonio P (2002) Effect of estrogen replacement plus low-dose alendronate treatment on bone density in surgically postmenopausal women with osteoporosis. J Clin Endocrinol Metab 87:1502–1508PubMedGoogle Scholar
  23. 23.
    Kiel D (1995) Assessing vertebral fractures. National Osteoporosis Foundation Working Group on Vertebral Fractures. J Bone Miner Res 10:518–523PubMedGoogle Scholar
  24. 24.
    Rand TH, Seidl G, Kainberger F, Resch A, Hittmair K, Schneider B, Gluer CC, Imhof H (1997) Impact of spinal degenerative changes on the evaluation of bone mineral density with dual energy X-ray absorptiometry (DXA). Calcif Tissue Int 60:430–433PubMedGoogle Scholar
  25. 25.
    Orwell ES, Oviatt KS, Mann T (1990) The impact of osteophytic and vascular calcification on vertebral mineral density measurement in men. J Clin Endocrinol Metab 70:1202–1207PubMedGoogle Scholar
  26. 26.
    Masud T, Keen R, Nandra D, Jawed S, Doyle DV, Spector TD (1996) Facet joint osteoarthritis and bone density measurements. In: Papapoulos SE, Lips P, Pols HAP, Johnston CC, Delmas PD (eds) Osteoporosis. Elsevier Science, Amsterdam, pp 167–170Google Scholar
  27. 27.
    Egger M, Juni P, Bartlett C, CONSORT Group (Consolidated Standards of Reporting of Trials) (2001) Value of flow diagrams in reports of randomized controlled trials. JAMA 285:1996–1999PubMedGoogle Scholar
  28. 28.
    Harrington JT, Ste-Marie LG, Brandi ML, Civitelli R, Fardellone P, Grauer A, Barton I, Boonen S (2004) Risedronate rapidly reduces the risk for nonvertebral fractures in women with postmenopausal osteoporosis. Calcif Tissue Int 7:129–135CrossRefGoogle Scholar
  29. 29.
    Sorensen OH, Crawford GM, Mulder H, Hosking DJ, Gennari C, Mellstrom D, Pack S, Wenderoth D, Cooper C, Reginster JY (2003) Long-term efficacy of risedronate: a 5-year placebo-controlled clinical experience. Bone 32:120–126PubMedGoogle Scholar
  30. 30.
    Dufresne TE, Chmielewski PA, Manhart MD, Johnson TD, Borah B (2003) Risedronate preserves bone architecture in early postmenopausal women in 1 year as measured by three-dimensional microcomputed tomography. Calcif Tissue Int 73:423–432PubMedGoogle Scholar
  31. 31.
    Dougherty JA (2002) Risedronate for the prevention and treatment of corticosteroid-induced osteoporosis. Ann Pharmacother 36:512–516PubMedGoogle Scholar
  32. 32.
    Lamb EJ, Wong T, Smith DJ, Simpson DE, Coakley AJ, Moniz C, Muller AF (2002) Metabolic bone disease is present at diagnosis in patients with inflammatory bowel disease. Aliment Pharmacol Ther 16:1895–1902PubMedGoogle Scholar
  33. 33.
    Van Staa TP, Laan RF, Barton IP, Cohen S, Reid DM, Cooper C (2003) Bone density threshold and other predictors of vertebral fracture in patients receiving oral glucocorticoid therapy. Arthritis Rheum 48:3224–3229PubMedGoogle Scholar
  34. 34.
    Clements D, Compston JE, Evans WD, Rhodes J (1993) Hormone replacement therapy prevents bone loss in patients with inflammatory bowel disease. Gut 34:1543–1546PubMedGoogle Scholar
  35. 35.
    Haderslev KV, Tjellesen L, Sorensen HA, Staun M (2000) Alendronate increases lumbar spine bone mineral density in patients with Crohn’s disease. Gastroenterology 119:639–646PubMedGoogle Scholar
  36. 36.
    Bartram SA, Peaston RT, Rawlings DJ, Francis RM, Thompson NP (2003) A randomized controlled trial of calcium with vitamin D, alone or in combination with intravenous pamidronate, for the treatment of low bone mineral density associated with Crohn’s disease. Aliment Pharmacol Ther 18:1121–1127PubMedGoogle Scholar
  37. 37.
    von Tirpitz C, Klaus J, Steinkamp M, Hofbauer LC, Kratzer W, Mason R, Boehm BO, Adler G, Reinshagen M (2003) Therapy of osteoporosis in patients with Crohn’s disease: a randomized study comparing sodium fluoride and ibandronate. Aliment Pharmacol Ther 17:807–816PubMedGoogle Scholar
  38. 38.
    von Tirpitz C, Klaus J, Bruckel J, Rieber A, Scholer A, Adler G, Bohm BO, Reinshagen M (2000) Increase of bone mineral density with sodium fluoride in patients with Crohn’s disease. Eur J Gastroenterol Hepatol 12:19–24PubMedGoogle Scholar
  39. 39.
    Abitbol V, Mary JY, Roux C, Soule JC, Belaiche J, Dupas JL, Gendre JP, Lerebours E, Chaussade S, Groupe D’études Thérapeutiques des Affections Inflammatoires Digestives (GETAID) (2002) Osteoporosis in inflammatory bowel disease: effect of calcium and vitamin D with or without fluoride. Aliment Pharmacol Ther 16:919–927PubMedGoogle Scholar
  40. 40.
    Stockbrugger RW, Schoon EJ, Bollani S, Mills PR, Israeli E, Landgraf L, Felsenberg D, Ljunghall S, Nygard G, Persson T, Graffner H, Bianchi Porro G, Ferguson A (2002) Discordance between the degree of osteopenia and the prevalence of spontaneous vertebral fractures in Crohn’s disease. Aliment Pharmacol Ther 16:1519–1527PubMedGoogle Scholar
  41. 41.
    Navarro F, Hanauer SB (2003) Treatment of inflammatory bowel disease: safety and tolerability issues. Am J Gastroenterol 98 [Suppl 12]:S18–23Google Scholar
  42. 42.
    Hamilton B, McCoy K, Taggart H (2003) Tolerability and compliance with risedronate in clinical practice. Osteoporos Int 14:259–262PubMedGoogle Scholar

Copyright information

© International Osteoporosis Foundation and National Osteoporosis Foundation 2005

Authors and Affiliations

  • Stefano Palomba
    • 1
    • 7
  • Francesco OrioJr.
    • 2
  • Francesco Manguso
    • 3
  • Angela Falbo
    • 1
  • Tiziana Russo
    • 1
  • Achille Tolino
    • 4
  • Libuse Tauchmanovà
    • 2
  • Annamaria Colao
    • 2
  • Patrizia Doldo
    • 5
  • Pasquale Mastrantonio
    • 6
  • Fulvio Zullo
    • 1
  1. 1.Department of Obstetrics and GynecologyUniversity “Magna Graecia” of CatanzaroCatanzaroItaly
  2. 2.Department of Molecular and Clinical Endocrinology and OncologyUniversity “Federico II” of NaplesNaplesItaly
  3. 3.Department of GastroenterologyUniversity “Federico II” of NaplesNaplesItaly
  4. 4.Department of Obstetrics and GynecologyUniversity “Federico II” of NaplesNaplesItaly
  5. 5.Department of GastroenterologyUniversity “Magna Graecia” of CatanzaroCatanzaroItaly
  6. 6.Department of Obstetrics and GynecologyUniversity of MessinaMessinaItaly
  7. 7.NaplesItaly

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