Journal of Bone and Mineral Metabolism

, Volume 30, Issue 6, pp 715–721 | Cite as

The effect of risedronate (17.5 mg/week) treatment on quality of life in Japanese women with osteoporosis: a prospective observational study

  • Toshitaka Nakamura
  • Mitsuharu Osawa
  • Makoto Itoh
  • Hiromichi Yamaguchi
  • Norio Iinuma
  • Yutaka Hayakawa
  • Hitoshi Suzuki
  • Toshiaki Kamisaki
  • Satoshi Iwayama
  • Masahiko Nishikawa
Original Article


A prospective observational study to test the effects of risedronate 17.5 mg/week treatment on quality of life (QOL) of 1,363 Japanese female patients with osteoporosis showed QOL improvement after 12 weeks of administration. Comorbid factors such as ischemic heart disease, hip osteoarthritis, and higher values of FRAX blunted the effects of QOL of the treatment. Few studies have investigated the effect of osteoporosis treatment on QOL in relationship to comorbid factors other than osteoporosis and fracture. Efficacy was determined by changes over time in EQ-5D at baseline, at 12 and 24 weeks, and at the final assessment. Factors affecting changes in EQ-5D were evaluated with a multivariate analysis. Safety was determined by assessing the incident rate of adverse events. The improvement of EQ-5D compared to baseline was observed as significant after 12 weeks of treatment (p < 0.001). The greatest improvement was observed in the dimension of “pain/discomfort” by the multivariate analysis (p < 0.001). Factors affecting QOL improvement were FRAX value without BMD, age, glucocorticoid use, ischemic heart disease, hip osteoarthritis, and pain. The incidence rate of drug-related adverse events was 4.72 % (95 % confidence interval 3.63–6.02 %). Risedronate at 17.5 mg/week improved the QOL in patients with osteoporosis among Japanese women, and comorbidity factors decreased the effects.


EQ-5D FRAX Comorbid factors Ischemic heart disease Osteoarthritis 


  1. 1.
    (2000) Osteoporosis prevention, diagnosis, and therapy. NIH Consensus Statement 17:1–45Google Scholar
  2. 2.
    Sennerby U, Melhus H, Gedeborg R, Byberg L, Garmo H, Ahlbom A, Pedersen NL, Michaëlsson K (2009) Cardiovascular diseases and risk of hip fracture. JAMA 302:1666–1673PubMedCrossRefGoogle Scholar
  3. 3.
    Vestergaard P, Rejnmark L, Mosekilde L (2009) Hypertension is a risk factor for fractures. Calcif Tissue Int 84:103–111PubMedCrossRefGoogle Scholar
  4. 4.
    Carbone L, Buzková P, Fink HA, Lee JS, Chen Z, Ahmed A, Parashar S, Robbins JR (2010) Hip fractures and heart failure: findings from the Cardiovascular Health Study. Eur Heart J 31:77–84PubMedCrossRefGoogle Scholar
  5. 5.
    Viégas M, Costa C, Lopes A, Griz L, Medeiro MA, Bandeira F (2011) Prevalence of osteoporosis and vertebral fractures in postmenopausal women with type 2 diabetes mellitus and their relationship with duration of the disease and chronic complications. J Diabetes Complications 25:216–221Google Scholar
  6. 6.
    Melton LJ 3rd, Leibson CL, Achenbach SJ, Therneau TM, Khosla S (2008) Fracture risk in type 2 diabetes: update of a population-based study. J Bone Miner Res 23:1334–1342PubMedCrossRefGoogle Scholar
  7. 7.
    Janghorbani M, Van Dam RM, Willett WC, Hu FB (2007) Systematic review of type 1 and type 2 diabetes mellitus and risk of fracture. Am J Epidemiol 166:495–505PubMedCrossRefGoogle Scholar
  8. 8.
    Samelson EJ, Cupples LA, Broe KE, Hannan MT, O’Donnell CJ, Kiel DP (2007) Vascular calcification in middle-age and long term risk of hip fracture: the Framingham Study. J Bone Miner Res 22:1449–1454PubMedCrossRefGoogle Scholar
  9. 9.
    Bagger YZ, Rasmussen HB, Alexandersen P, Werge T, Christiansen C, Tankó LB, PERF study group (2007) Links between cardiovascular disease and osteoporosis in postmenopausal women: serum lipids or atherosclerosis per se? Osteoporos Int 18:505–512PubMedCrossRefGoogle Scholar
  10. 10.
    Holmberg AH, Johnell O, Nilsson PM, Nilsson J, Berglund G, Akesson K (2006) Risk factors for fragility fracture in middle age. A prospective population-based study of 33,000 men and women. Osteoporos Int 17:1065–1077PubMedCrossRefGoogle Scholar
  11. 11.
    Yamaguchi T, Sugimoto T, Yano S, Yamauchi M, Sowa H, Chen Q, Chihara K (2002) Plasma lipids and osteoporosis in postmenopausal women. Endocr J 49:211–217PubMedCrossRefGoogle Scholar
  12. 12.
    Miyakoshi N, Itoi E, Kobayashi M, Kodama H (2003) Impact of postural deformities and spinal mobility on quality of life in postmenopausal osteoporosis. Osteoporos Int 14:1007–1012PubMedCrossRefGoogle Scholar
  13. 13.
    Anonymous (2006) Guidelines for prevention and treatment of osteoporosis. Life Science Publishing, Tokyo, pp 61–63Google Scholar
  14. 14.
    Bazzichi L, Maser J, Piccinni A, Rucci P, Del Debbio A, Vivarelli L, Catena M, Bounani S, Merlini G, Bombardieri S, DellOsso L (2005) Quality of life in rheumatoid arthritis: impact of disability and lifetime depressive spectrum symptomatology. Clin Exp Rheumatol 23:783–788PubMedGoogle Scholar
  15. 15.
    Hopman-Rock M, Kraaimaat FW, Bijlsma JW (1997) Quality of life in elderly subjects with pain in the hip or knee. Qual Life Res 6:67–76PubMedCrossRefGoogle Scholar
  16. 16.
    van der Waal JM, Terwee CB, van der Windt DA, Bouter LM, Dekker J (2005) Health-related and overall quality of life of patients with chronic hip and knee complaints in general practice. Qual Life Res 14:795–803PubMedCrossRefGoogle Scholar
  17. 17.
    Moskowitz RW (2009) The burden of osteoarthritis: clinical and quality-of-life issues. Am J Manag Care 15:S223–S229PubMedGoogle Scholar
  18. 18.
    Altman RD (2010) Early management of osteoarthritis. Am J Manag Care 16(suppl):S41–S47Google Scholar
  19. 19.
    Muraki S, Akune T, Oka H, En-Yo Y, Yoshida M, Saika A, Suzuki T, Yoshida H, Ishibashi H, Tokimura F, Yamamoto S, Nakamura K, Kawaguchi H, Yoshimura N (2010) Impact of knee and low back pain on health-related quality of life in Japanese women: the Research on Osteoarthritis Against Disability (ROAD). Med Rheumatol 20:444–451CrossRefGoogle Scholar
  20. 20.
    Brooks R with the EuroQol Group (1996) EuroQol: the current state of play. Health Policy 37:53–72CrossRefGoogle Scholar
  21. 21.
    Ikegami N, Fukuhara S, Shimozuma K, Ikeda S (2001) QOL evaluation handbook for clinical practice. Igakushoin, Tokyo, pp 14–18Google Scholar
  22. 22.
    Saika A, Matsunaka H (2005) Studies of the effect of risedronate on removal of lower back pain in patients with osteoporosis and the effect on improvement of QOL. Osteoporos Jpn 13:485–490Google Scholar
  23. 23.
    Ohtori S, Akazawa T, Murata Y, Kinoshita T, Yamashita M, Nakagawa K, Inoue G, Nakamura J, Orita S, Ochiai N, Kishida S, Takaso M, Eguchi Y, Yamauchi K, Suzuki M, Aoki Y, Takahashi K (2010) Risedronate decreases bone resorption and improves low back pain in postmenopausal osteoporosis patients without vertebral fractures. J Clin Neurosci 17:209–213PubMedCrossRefGoogle Scholar
  24. 24.
    Kushida K, Fukunaga M, Kishimoto H, Shiraki M, Itabashi A, Inoue T, Kaneda K, Morii H, Nawata H, Yamamoto K, Ohashi Y, Orimo H (2004) A comparison of incidences of vertebral fracture in Japanese patients with involutional osteoporosis treated with risedronate and etidronate: a randomized, double-masked trial. J Bone Miner Metab 22:469–478PubMedGoogle Scholar
  25. 25.
    Ohbayashi H (2009) Examination of beneficial effects of risedronate in improving quality of life during long-term treatment of primary osteoporosis. Nippon Rinsho 67:2009Google Scholar
  26. 26.
    Fujita T, Ohue M, Nakajima M, Fujii Y, Miyauchi A, Takagi Y (2011) Comparison of the effects of elcatonin and risedronate on back and knee pain by electroalgometry using fall of skin impedance and quality of life assessment using SF-36. J Bone Miner Metab 29:588–597PubMedCrossRefGoogle Scholar
  27. 27.
    De Laet C, Kanis JA, Odén A, Johanson H, Johnell O, Delmas P, Eisman JA, Kroger H, Fujiwara S, Garnero P, McCloskey EV, Mellstrom D, Melton LJ 3rd, Meunier PJ, Pols HA, Reeve J, Silman A, Tenenhouse A (2005) Body mass index as a predictor of fracture risk: a meta-analysis. Osteoporos Int 16:1330–1338PubMedCrossRefGoogle Scholar
  28. 28.
    Marshall D, Johnell O, Wedel H (1996) Meta-analysis of how well measures of bone mineral density predict occurrence of osteoporotic fracture. BMJ 312:1254–1259PubMedCrossRefGoogle Scholar
  29. 29.
    Johnell O, Kanis JA, Oden A, Johansson H, De Laet C, Delmas P, Eisman JA, Fujiwara S, Kroger H, Mellstrom D, Meunier PJ, Melton LJ 3rd, O’Neill T, Pols H, Reeve J, Silman A, Tenenhouse A (2005) Predictive value of BMD for hip and other fractures. J Bone Miner Res 20:1185–1194PubMedCrossRefGoogle Scholar
  30. 30.
    Klotzbuecher CM, Ross PD, Landsman PB, Abbott TA III, Berger M (2000) Patients with prior fractures have an increased risk of future fractures: a summary of the literature and statistical synthesis. J Bone Miner Res 15:721–739PubMedCrossRefGoogle Scholar
  31. 31.
    Kanis JA, Johnell O, De Laet C, Johansson H, Oden A, Delmas P, Eisman J, Fujiwara S, Garmero P, Kroger H, McCloskey EV, Mellstrom D, Melton LJ, Pols H, Reeve J, Silman A, Tenenhouse A (2004) A meta-analysis of previous fracture and subsequent fracture risk. Bone (NY) 35:375–382Google Scholar
  32. 32.
    Kanis JA, Johnell O, Oden A, Johansson H, De Laet C, Eisman JA, Fujiwara S, Kroger H, McCloskey EV, Mellstrom D, Melton LJ, Pols H, Reeve J, Silman A, Tenenhouse A (2005) Smoking and fracture risk: a meta-analysis. Osteoporos Int 16:155–162PubMedCrossRefGoogle Scholar
  33. 33.
    Kanis JA, Johansson H, Johnell O, Oden A, De Laet C, Eisman JA, Pols H, Tenenhouse A (2005) Alcohol intake as a risk factor for fracture. Osteoporos Int 16:737–742PubMedCrossRefGoogle Scholar
  34. 34.
    van Staa TP, Leufkens HG, Cooper C (2002) The epidemiology of corticosteroid-induce osteoporosis: a meta-analysis. Osteoporos Int 13:777–787PubMedCrossRefGoogle Scholar
  35. 35.
    Kanis JA, Johansson H, Oden A, Johnell O, de Laet C, Melton LJ III, Tenenhouse A, Reeve J, Silman AJ, Pols HA, Eisman JA, McCloskey EV, Mellstrom D (2004) A meta-analysis of prior corticosteroid use and fracture risk. J Bone Miner Res 19:893–899PubMedCrossRefGoogle Scholar
  36. 36.
    Kanis JA, Johansson H, Oden A, Johnell O, De Laet C, Eisman JA, McCloskey EV, Mellstrom D, Melton LJ 3rd, Pols HA, Reeve J, Silman AJ, Tenenhouse A (2004) A family history of fracture and fracture risk: a meta-analysis. Bone (NY) 35:1029–1037Google Scholar
  37. 37.
    Hooyman J, Melton LR, Nelson A, O’Fallon W, Riggs B (1984) Fractures after rheumatoid arthritis. A population-based study. Arthritis Rheum 27:1353–1361PubMedCrossRefGoogle Scholar
  38. 38.
    van Staa TP, Geusens P, Bijlsma JW, Leufkens HG, Cooper C (2006) Clinical assessment of the long-term risk of fracture in patients with rheumatoid arthritis. Arthritis Rheum 54:3104–3112PubMedCrossRefGoogle Scholar
  39. 39.
    Kishimoto H, Fukunaga M, Kushida K, Shiraki M, Itabashi A, Nawata H, Nakamura T, Ohta H, Takaoka K, Ohashi Y; Risedronate Phase III Research Group (2006) Efficacy and tolerability of once-weekly administration of 17.5 mg risedronate in Japanese patients with involutional osteoporosis: a comparison with 2.5 mg once-daily dosage regimen. J Bone Miner Metab 24:405–413, 439Google Scholar
  40. 40.
    Peter CP, Kindt MV, Majka JA (1998) Comparative study of potential for bisphosphonates to damage gastric mucosa of rats. Dig Dis Sci 43:1009–1015PubMedCrossRefGoogle Scholar
  41. 41.
    Bone HG, Adami S, Rizzoli R, Favus M, Ross PD, Santra A, Praharada S, Daifotis A, Orloff J, Yates J (2000) Weekly administration of alendronate: rationale and plan for clinical assessment. Clin Ther 22:15–28PubMedCrossRefGoogle Scholar
  42. 42.
    Shiraki M, Fukunaga M, Kushida K, Kishimoto H, Taketani Y, Minaguchi H, Inoue T, Morita R, Morii H, Yamamoto K, Ohashi Y, Orimo H (2003) A double-blind dose-ranging study of risedronate in Japanese patients with osteoporosis (a study by the Risedronate Late Phase II Research Group). Osteoporos Int 14:225–234PubMedGoogle Scholar
  43. 43.
    Harris ST, Watts NB, Genant HK, McKeever CD, Hangartner T, Keller M, Chesnut CH 3rd, Brown J, Eriksen EF, Hoseyni MS, Axelrod DW, Miller PD (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 282:1344–1352PubMedCrossRefGoogle Scholar
  44. 44.
    Reginster J, Minne HW, Sorensen OH, Hooper M, Roux C, Brandi ML, Lund B, Ethgen D, Pack S, Roumagnac I, Eastell R (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 11:83–91PubMedCrossRefGoogle Scholar
  45. 45.
    Takakuwa M, Iwamoto J, Konishi M, Qi Zhou Itabashi K (2011) Risedronate improves proximal femur bone density and geometry in patients with osteoporosis or osteopenia and clinical risk factors of fractures: a practice-based observational study. J Bone Miner Metab 29:88–95PubMedCrossRefGoogle Scholar

Copyright information

© The Japanese Society for Bone and Mineral Research and Springer 2012

Authors and Affiliations

  • Toshitaka Nakamura
    • 1
  • Mitsuharu Osawa
    • 2
  • Makoto Itoh
    • 3
  • Hiromichi Yamaguchi
    • 2
  • Norio Iinuma
    • 2
  • Yutaka Hayakawa
    • 2
  • Hitoshi Suzuki
    • 2
  • Toshiaki Kamisaki
    • 3
  • Satoshi Iwayama
    • 3
  • Masahiko Nishikawa
    • 3
  1. 1.Department of Orthopedic SurgeryUniversity of Occupational and Environmental HealthKitakyushuJapan
  2. 2.Department of Drug Promotion and Evolution CoordinationHeadquarters of Corporate Regulatory Compliance, Safety and Quality Assurance, Eisai Co., Ltd.TokyoJapan
  3. 3.Post-Marketing Medical Research DepartmentAjinomoto Pharmaceuticals Co., Ltd.TokyoJapan

Personalised recommendations