Skip to main content

Advertisement

SpringerLink
Log in

Risedronate decreases fracture risk in patients selected solely on the basis of prior vertebral fracture

  • Original Article
  • Published:
Osteoporosis International Aims and scope Submit manuscript

Abstract

The aim of this study was to examine the effects of risedronate (5 mg/daily) in patients identified solely on the basis of a prior fragility fracture, without BMD as an inclusion criterion. A total of 1,802 patients were examined from the VERT-NA and VERT-MN clinical trials. Lateral radiographs (T4 to L4) were obtained at baseline and annually; incident fractures were evaluated using quantitative and semiquantitative methods at the central facility. BMD was measured at the lumbar spine and femoral neck by dual-energy X-ray absorptiometry. Secondary analyses evaluated vertebral fracture efficacy in patient subgroups categorized according to the presence of risk factors for osteoporosis at baseline (age, femoral neck BMD, lumbar spine BMD, more severe BMD, height, weight, body mass index, prevalent nonvertebral fracture status, smoking, and bone turnover marker levels). Over 3 years, risedronate reduced the risk of new vertebral fractures by 44% (95% CI, 28% to 56%) compared with placebo. In patients subgrouped according to the presence or absence of putative risk factors, the efficacy of risedronate was comparable across all groups (all treatment-by-non BMD subgroup interactions p≥0.210). Adjustment for age, baseline BMD, and prevalent vertebral fractures on fracture risk gave results similar to the unadjusted analysis. In patients taking placebo, the incidence of new vertebral fracture was higher in several of the high-risk categories (elderly, T-score ≤−2.5 SD). In conclusion, the findings of this study suggest that risedronate is effective in patients identified solely on the basis of a prior fragility fracture and that the efficacy of risedronate in the reduction of vertebral fractures is largely independent of the presence of clinical risk factors for osteoporotic fracture.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Subscribe and save

Springer+ Basic
$34.99 /Month
  • Get 10 units per month
  • Download Article/Chapter or eBook
  • 1 Unit = 1 Article or 1 Chapter
  • Cancel anytime
Subscribe now

Buy Now

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Fig. 1

Similar content being viewed by others

Abbreviations

LS:

Lumbar spine

VERT-MN:

Vertebral Efficacy with Risedronate Therapy Multinational

VERT-NA:

Vertebral Efficacy with Risedronate Therapy North American

References

  1. Consensus Development Conference (1991) Diagnosis, prophylaxis and treatment of osteoporosis. Am J Med 90:107–110

    Article  PubMed  Google Scholar 

  2. World Health Organization (1994) Assessment of fracture risk and its application to screening for postmenopausal osteoporosis. WHO Technical Report Series, No. 843. WHO, Geneva

  3. Kanis JA, Melton LJ, Christiansen C, Johnston CC, Khaltaev N (1994) The diagnosis of osteoporosis. J Bone Miner Res 9:1137–1141

    CAS  PubMed  Google Scholar 

  4. Miller PD, Njeh CF, Jankowski LG, Lenchik L (2002) What standards by which bone mass measurement at peripheral sites should be used in the diagnosis of osteoporosis. J Clin Densitom 6 [Suppl]:S39–S45

  5. The Writing Group for the ISCD Position Development Conference (2004) Executive summary. J Clin Densitom 7:7–12

    Article  PubMed  Google Scholar 

  6. Kanis JA, Gluer CC, for the Committee of Scientific Advisors, International Osteoporosis Foundation (2000) An update on the diagnosis and assessment of osteoporosis with densitometry. Osteoporos Int 11:192–202

    Article  CAS  PubMed  Google Scholar 

  7. Black DM, Reiss TF, Nevitt MC, Cahley J, Karpf D, Cummings SR (1993) Design of the fracture intervention trial. Osteoporos Int [Suppl 3]:S29–S39

  8. Black DM, Cummings SR, Karpf DB, Cauley JA, Thompson DE, Nevitt MC et al (1996) Randomised trial of effect of alendronate on risk of fracture in women with existing vertebral fractures. Lancet 348:1535–1541

    Article  CAS  PubMed  Google Scholar 

  9. Cummings SR, Black DM, Thompson DE, Applegate WB, Barrett-Connor E, Musliner TA et al (1998) Effect of alendronate on risk of fracture in women with low bone density but without vertebral fracture. JAMA 280:2077–2082

    Article  CAS  PubMed  Google Scholar 

  10. Ettinger B, Black DM, Mitlak BH, Knickerbocker RK, Nickelson T, Genant HK et al (1999) Reduction in vertebral fracture risk in postmenopausal women with osteoporosis treated with raloxifene: results from a 3 year randomised clinical trial. JAMA 282:637–645

    Article  CAS  PubMed  Google Scholar 

  11. Meunier PJ, Roux C, Seeman E, Ortolani S, Badurski J, Spector T et al (2004) The effects of strontium renelate on the risk of vertebral fracture in women with postmenopausal osteoporosis. NEJM 350:459–468

    Article  CAS  PubMed  Google Scholar 

  12. McCloskey EV, Selby P, Davies M, Robinson J, Francis RM, Adams J et al (2004) Clodronate reduces vertebral fracture risk in women with postmenopausal or secondary osteoporosis: results of a double blind placebo-controlled 3 year study. J Bone Miner Res 19:728–736

    CAS  PubMed  Google Scholar 

  13. Eichner SF, Lloyd KB, Timpe EM (2003) Comparing therapies for postmenopausal osteoporosis prevention and treatment Ann Pharmacother 37:711–724

    Article  CAS  Google Scholar 

  14. Siris E, Chen Y-T, Abbott TA, Barrett-Connor E, Miller PD, Wehren LE, Berger ML (2004) Bone mineral density thresholds for pharmacological intervention to prevent fractures. Arch Int Med 164 (in press)

  15. Kanis JA (2002) Diagnosis of osteoporosis and assessment of fracture risk. Lancet 359:1929–1936

    Article  PubMed  Google Scholar 

  16. Delmas PD, Eastell R, Garnero P et al (2000) The use of biochemical markers of bone turnover in osteoporosis. Committee of Scientific Advisors of the International Osteoporosis Foundation. Osteoporos Int 11[Suppl 6]:S2–S17

  17. Kanis JA, Johnell O, Oden A et al (2001) Ten year probabilities of osteoporotic fractures according to BMD and diagnostic thresholds. Osteoporos Int 12:989–995

    Article  CAS  PubMed  Google Scholar 

  18. Klotzbuecher CM, Ross PD, Landsman PB et al (2000) Patients with prior fractures have an increased risk of future fractures: a summary of the literature and statistical synthesis. J Bone Miner Res 15:721–739

    CAS  PubMed  Google Scholar 

  19. Harris ST, Watts NB, Genant HK et al (1999) Effects of risedronate treatment on vertebral and nonvertebral fractures in women with postmenopausal osteoporosis: a randomized controlled trial. Vertebral Efficacy with Risedronate Therapy (VERT) Study Group. JAMA 282:1344–1352

    Article  CAS  PubMed  Google Scholar 

  20. Reginster J, Minne HW, Sorensen OH et al (2000) Randomized trial of the effects of risedronate on vertebral fractures in women with established postmenopausal osteoporosis. Vertebral Efficacy with Risedronate Therapy (VERT) Study Group. Osteoporos Int 11:83–91

    Article  CAS  PubMed  Google Scholar 

  21. Looker AC, Wahner HW, Dunn WL et al (1998) Updated data on proximal femur bone mineral levels of US adults. Osteoporos Int 8:468–489

    Article  CAS  PubMed  Google Scholar 

  22. Kanis JA, McCloskey EV, Beneton MN (1997) Guidelines for diagnosis and management of osteoporosis. The European Foundation for Osteoporosis and Bone Disease. Osteoporos Int 7:390–406

    CAS  PubMed  Google Scholar 

  23. No author listed (1998) Osteoporosis: review of the evidence for prevention, diagnosis and treatment and cost-effective analysis. Osteoporos Int 8[Suppl 4]:S7–S80

  24. Kanis JA (2002) Assessing the risk of vertebral osteoporosis. Singapore Med J 43:100–105

    CAS  PubMed  Google Scholar 

  25. Wilson PW, D’Agostino RB, Levy D et al (1998) Prediction of coronary heart disease using risk factor categories. Circulation 97:1837–1847

    CAS  PubMed  Google Scholar 

  26. McClung MR, Geusens P, Miller PD et al (2001) Effect of risedronate on the risk of hip fracture in elderly women. Hip Intervention Program Study Group. N Engl J Med 344:333–340

    Article  CAS  PubMed  Google Scholar 

  27. Rossouw JE, Anderson GL, Prentice RL et al (2002) Risks and benefits of estrogen plus progestin in healthy postmenopausal women: principal results from the Women’s Health Initiative randomized controlled trial. JAMA 288:321–333

    CAS  PubMed  Google Scholar 

  28. Chapuy MC, Arlot ME, Delmas PD et al (1994) Effect of calcium and cholecalciferol treatment for three years on hip fractures in elderly women. BMJ 308:1081–1082

    CAS  PubMed  Google Scholar 

  29. Chapuy MC, Arlot ME, Duboeuf F et al (1992) Vitamin D3 and calcium to prevent hip fractures in the elderly women. N Engl J Med 327:1637–1642

    CAS  PubMed  Google Scholar 

  30. Marcus R, Wang O, Satterwhite J et al (2003) The skeletal response to teriparatide is largely independent of age, initial bone mineral density, and prevalent vertebral fractures in postmenopausal women with osteoporosis. J Bone Miner Res 18:18–23

    CAS  PubMed  Google Scholar 

  31. Watts NB, Josse RG, Hamdy RC et al (2003) Risedronate prevents new vertebral fractures in postmenopausal women at high risk. J Clin Endocrinol Metab 88:542–549

    Article  CAS  PubMed  Google Scholar 

  32. Kanis JA, Johnell O, Black DM et al (2003) Effect of raloxifene on the risk of new vertebral fracture in postmenopausal women with osteopenia or osteoporosis: a reanalysis of the Multiple Outcomes of Raloxifene Evaluation trial. Bone 33:293–300

    Article  CAS  PubMed  Google Scholar 

  33. Black DM, Thompson DE, Bauer DC et al (2000) Fracture risk reduction with alendronate in women with osteoporosis: the Fracture Intervention Trial. FIT Research Group. J Clin Endocrinol Metab 85:4118–4124

    Article  CAS  PubMed  Google Scholar 

  34. Johnell O, Kanis JA, Black DM, Balogh A, Poor G, Saker S, Zhou C, Pavo I (2004) Associations between baseline risk factors and vertebral fracture risk in the Multiple Outcomes of Raloxifene Evaluation (MORE) study. J Bone Miner Res 19:764–772

    PubMed  Google Scholar 

Download references

Author information

Authors and Affiliations

  1. Centre for Metabolic Bone Diseases (WHO Collaborating Centre), University of Sheffield Medical School, Beech Hill Road, Sheffield, S10 2RX, UK

    J. A. Kanis

  2. Procter and Gamble Pharmaceuticals, Egham, Surrey, UK

    I. P. Barton

  3. Department of Orthopaedics, Malmö General Hospital, Malmö, Sweden

    O. Johnell

Authors
  1. J. A. Kanis
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. I. P. Barton
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. O. Johnell
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to J. A. Kanis.

Rights and permissions

Reprints and permissions

About this article

Cite this article

Kanis, J.A., Barton, I.P. & Johnell, O. Risedronate decreases fracture risk in patients selected solely on the basis of prior vertebral fracture. Osteoporos Int 16, 475–482 (2005). https://doi.org/10.1007/s00198-004-1698-y

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s00198-004-1698-y

Keywords

Search

Navigation