Skip to main content
Top
Published in: Calcified Tissue International 2/2004

01-04-2004 | Clinical Investigations

Risedronate Rapidly Reduces the Risk for Nonvertebral Fractures in Women with Postmenopausal Osteoporosis

Authors: J. T. Harrington, L. -G. Ste-Marie, M. L. Brandi, R. Civitelli, P. Fardellone, A. Grauer, I. Barton, S. Boonen

Published in: Calcified Tissue International | Issue 2/2004

Login to get access

Abstract

Prevention of nonvertebral fractures, which account for a substantial proportion of osteoporotic fractures, is an important goal of osteoporosis treatment. Risedronate, a pyridinyl bisphosphonate, significantly reduces clinical vertebral fracture incidence within 6 months. To determine the effect of risedronate on osteoporosis-related nonvertebral fractures, data from four large, randomized, double-blind, placebo-controlled, Phase III studies were pooled and analyzed. The population analyzed consisted of postmenopausal women, with and without vertebral fractures, who had low bone mineral density (lumbar spine T-score <−2.5). Patients received placebo (N = 608) or risedronate 5 mg daily (N = 564) for 1 to 3 years. At baseline, 58% had at least one prevalent vertebral fracture, and the mean lumbar spine T-score was −3.4. Among placebo-treated patients, the presence of prevalent vertebral fractures did not increase the risk of incident nonvertebral fractures overall, although fractures of the humerus and hip and pelvis were more common in patients who had prevalent vertebral fractures than in those who did not. Risedronate 5 mg significantly reduced the incidence of nonvertebral fractures within 6 months compared with control. After 1 year, nonvertebral fracture incidence was reduced by 74% compared with control (P = 0.001), and after 3 years, the incidence was reduced by 59% (P = 0.002). The results indicate that risedronate significantly reduces the incidence of osteoporosis-related nonvertebral fractures within 6 months.
Literature
1.
go back to reference NIH2001Consensus Development Panel on Osteoporosis Prevention, Diagnosis, and Therapy. Osteoporosis prevention, diagnosis, and therapy.JAMA285785795PubMed NIH2001Consensus Development Panel on Osteoporosis Prevention, Diagnosis, and Therapy. Osteoporosis prevention, diagnosis, and therapy.JAMA285785795PubMed
2.
go back to reference Melton III, LJ, Chrischilles, EA, Cooper, C, Lane, AW, Riggs, BL 1992Perspective. How many women have osteoporosis?J Bone Miner Res710051010PubMed Melton III, LJ, Chrischilles, EA, Cooper, C, Lane, AW, Riggs, BL 1992Perspective. How many women have osteoporosis?J Bone Miner Res710051010PubMed
3.
go back to reference O’Neill, TW, Felsenberg, D, Varlow, J, Cooper, C, Kanis, JA, Silman, AJ 1996The prevalence of vertebral deformity in European men and women: the European Vertebral Osteoporosis Study.J Bone Miner Res1110101018PubMed O’Neill, TW, Felsenberg, D, Varlow, J, Cooper, C, Kanis, JA, Silman, AJ 1996The prevalence of vertebral deformity in European men and women: the European Vertebral Osteoporosis Study.J Bone Miner Res1110101018PubMed
4.
go back to reference Melton III, LJ, Lane, AW, Cooper, C, Eastell, R, O’Fallon, WM, Riggs, BL 1993Prevalence and incidence of vertebral deformities.Osteoporos Int3113119PubMed Melton III, LJ, Lane, AW, Cooper, C, Eastell, R, O’Fallon, WM, Riggs, BL 1993Prevalence and incidence of vertebral deformities.Osteoporos Int3113119PubMed
5.
go back to reference Eastell, R, Reid, DM, Compston, J, et al. 2001Secondary prevention of osteoporosis: When should a non-vertebral fracture be a trigger for action?QJM94575597CrossRefPubMed Eastell, R, Reid, DM, Compston, J,  et al. 2001Secondary prevention of osteoporosis: When should a non-vertebral fracture be a trigger for action?QJM94575597CrossRefPubMed
6.
go back to reference Melton III, LJ, Atkinson, EJ, Cooper, C, O’Fallon, WM, Riggs, BL 1999Vertebral fractures predict subsequent fractures.Osteoporos Int10214221CrossRefPubMed Melton III, LJ, Atkinson, EJ, Cooper, C, O’Fallon, WM, Riggs, BL 1999Vertebral fractures predict subsequent fractures.Osteoporos Int10214221CrossRefPubMed
7.
go back to reference Seeley, DG, Browner, WS, Nevitt, MC, Genant, HK, Scott, JC, Cummings, SR 1991Which fractures are associated with low appendicular bone mass in elderly women? The Study of Osteoporotic Fractures Research Group.Ann Intern Med115837842PubMed Seeley, DG, Browner, WS, Nevitt, MC, Genant, HK, Scott, JC, Cummings, SR 1991Which fractures are associated with low appendicular bone mass in elderly women? The Study of Osteoporotic Fractures Research Group.Ann Intern Med115837842PubMed
8.
go back to reference Black, DM, Cummings, SR, Genant, HK, Nevitt, MC, Palermo, L, Browner, W 1992Axial and appendicular bone density predict fractures in older women.J Bone Miner Res7633638PubMed Black, DM, Cummings, SR, Genant, HK, Nevitt, MC, Palermo, L, Browner, W 1992Axial and appendicular bone density predict fractures in older women.J Bone Miner Res7633638PubMed
9.
go back to reference Harris, ST, Watts, NB, Genant, HK, et al. 1999Effects of risedronate treatment on vertebral and non-vertebral fractures in women with postmenopausal osteoporosis. A randomized controlled trial.JAMA28213441352, for the Vertebral Efficacy with Risedronate Therapy (VERT) Study GroupPubMed Harris, ST, Watts, NB, Genant, HK,  et al. 1999Effects of risedronate treatment on vertebral and non-vertebral fractures in women with postmenopausal osteoporosis. A randomized controlled trial.JAMA28213441352, for the Vertebral Efficacy with Risedronate Therapy (VERT) Study GroupPubMed
10.
go back to reference Cohen, S, Levy, RM, Keller, M, et al. 1999Risedronate therapy prevents corticosteroid-induced bone loss.Arthritis Rheum4223092318CrossRefPubMed Cohen, S, Levy, RM, Keller, M,  et al. 1999Risedronate therapy prevents corticosteroid-induced bone loss.Arthritis Rheum4223092318CrossRefPubMed
11.
go back to reference Reid, DM, Hughes, RA, Laan, RF, Sacco-Gibson, NA, Wenderoth, DH, Adami, S, Eusebio, RA, Devogelaer, JP 2000Efficacy and safety of daily risedronate in the treatment of corticosteroid-induced osteoporosis in men and women: a randomized trial.J Bone Miner Res1510061013, for the European Corticosteroid-Induced Osteoporosis Treatment StudyPubMed Reid, DM, Hughes, RA, Laan, RF, Sacco-Gibson, NA, Wenderoth, DH, Adami, S, Eusebio, RA, Devogelaer, JP 2000Efficacy and safety of daily risedronate in the treatment of corticosteroid-induced osteoporosis in men and women: a randomized trial.J Bone Miner Res1510061013, for the European Corticosteroid-Induced Osteoporosis Treatment StudyPubMed
12.
go back to reference Hooper, M, Ebeling, P, Roberts, A, D’Emden, M, Nicholson, G, Crusan, C, Wenderoth, D, Ethgen, D 1999Risedronate prevents bone loss in early postmenopausal women (abstract).Calcif Tissue Int64S69, for the Australian Risedronate Prevention Study Group Hooper, M, Ebeling, P, Roberts, A, D’Emden, M, Nicholson, G, Crusan, C, Wenderoth, D, Ethgen, D 1999Risedronate prevents bone loss in early postmenopausal women (abstract).Calcif Tissue Int64S69, for the Australian Risedronate Prevention Study Group
13.
go back to reference Reginster, J, Minne, HW, Sorensen, OH, Hooper, M, Roux, C, Brandi, ML, Lund, B, Ethgen, D, Pack, S, Roumagnac, I, Eastell, R 2000Randomized trial of the effects of risedronate on vertebral fractures in women with established postmenopausal osteoporosis.Osteoporos Int118391, on behalf of the Vertebral Efficacy with Risedronate Therapy (VERT) Study GroupPubMed Reginster, J, Minne, HW, Sorensen, OH, Hooper, M, Roux, C, Brandi, ML, Lund, B, Ethgen, D, Pack, S, Roumagnac, I, Eastell, R 2000Randomized trial of the effects of risedronate on vertebral fractures in women with established postmenopausal osteoporosis.Osteoporos Int118391, on behalf of the Vertebral Efficacy with Risedronate Therapy (VERT) Study GroupPubMed
14.
go back to reference McClung, M, Bensen, W, Bolognese, M, et al. 1998Risedronate increases bone mineral density at the hip, spine and radius in postmenopausal women with low bone mass (abstract).Osteoporos Int8111 McClung, M, Bensen, W, Bolognese, M,  et al. 1998Risedronate increases bone mineral density at the hip, spine and radius in postmenopausal women with low bone mass (abstract).Osteoporos Int8111
15.
go back to reference Fogelman, I, Ribot, C, Smith, R, Ethgen, D, Sod, E, Reginster, JY 2000Risedronate reverses bone loss in postmenopausal women with low bone mass: results from a multinational, double-blind, placebo-controlled trial.J Clin Endocrinol Metab8518951900PubMed Fogelman, I, Ribot, C, Smith, R, Ethgen, D, Sod, E, Reginster, JY 2000Risedronate reverses bone loss in postmenopausal women with low bone mass: results from a multinational, double-blind, placebo-controlled trial.J Clin Endocrinol Metab8518951900PubMed
16.
go back to reference McClung, MR, Geusens, P, Miller, PD, et al. 2001Effect of risedronate on the risk of hip fracture in elderly women.N Engl J Med344333340, for the Hip Intervention Program Study GroupCrossRefPubMed McClung, MR, Geusens, P, Miller, PD,  et al. 2001Effect of risedronate on the risk of hip fracture in elderly women.N Engl J Med344333340, for the Hip Intervention Program Study GroupCrossRefPubMed
17.
go back to reference Watts, NB, Adami, S, Chesnut, CH 2001Risedronate reduces the risk of clinical vertebral fractures in just 6 months (abstract).J Bone Miner Res16S407 Watts, NB, Adami, S, Chesnut, CH 2001Risedronate reduces the risk of clinical vertebral fractures in just 6 months (abstract).J Bone Miner Res16S407
18.
go back to reference Lindsay, R, Burge, RT, Strauss, DM 2001The expected cost of new fractures in the year following a vertebral fracture (abstract).J Bone Miner Res16S275 Lindsay, R, Burge, RT, Strauss, DM 2001The expected cost of new fractures in the year following a vertebral fracture (abstract).J Bone Miner Res16S275
19.
go back to reference Lindsay, R, Silverman, SL, Cooper, C, et al. 2001Risk of new vertebral fracture in the year following a fracture.JAMA285320323PubMed Lindsay, R, Silverman, SL, Cooper, C,  et al. 2001Risk of new vertebral fracture in the year following a fracture.JAMA285320323PubMed
20.
go back to reference Black, DM, Thompson, DE, Bauer, DC, Ensrud, K, Musliner, T, Hochberg, MC, Nevitt, MC, Suryawanshi, S, Cummings, SR 2000Fracture risk reduction with alendronate in women with osteoporosis: the Fracture Intervention Trial.J Clin Endocrinol Metab8541184124, for the Fracture Intervention Trial Research GroupPubMed Black, DM, Thompson, DE, Bauer, DC, Ensrud, K, Musliner, T, Hochberg, MC, Nevitt, MC, Suryawanshi, S, Cummings, SR 2000Fracture risk reduction with alendronate in women with osteoporosis: the Fracture Intervention Trial.J Clin Endocrinol Metab8541184124, for the Fracture Intervention Trial Research GroupPubMed
21.
go back to reference Pols, HAP, Felsenberg, D, Hanley, DA, Stych, B, et al. 1999Multinational, 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.Osteoporos Int9461468, for the Fosamax International Trial Study GroupCrossRefPubMed Pols, HAP, Felsenberg, D, Hanley, DA, Stych, B,  et al. 1999Multinational, 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.Osteoporos Int9461468, for the Fosamax International Trial Study GroupCrossRefPubMed
22.
go back to reference Neer, RM, Arnaud, CD, Zanchetta, JR, et al. 2001Effect of parathyroid hormone (1–34) on fractures and bone mineral density in postmenopausal women with osteoporosis.N Engl J Med34414341441PubMed Neer, RM, Arnaud, CD, Zanchetta, JR,  et al. 2001Effect of parathyroid hormone (1–34) on fractures and bone mineral density in postmenopausal women with osteoporosis.N Engl J Med34414341441PubMed
23.
go back to reference Ettinger, B, Black, DM, Mitlak, BH, et al. 1999Reduction of vertebral fracture risk in postmenopausal women with osteoporosis treated with raloxifene: results from a 3-year randomized clinical trial.JAMA282637645, for the Multiple Outcomes of Raloxifene Evaluation (MORE) InvestigatorsPubMed Ettinger, B, Black, DM, Mitlak, BH,  et al. 1999Reduction of vertebral fracture risk in postmenopausal women with osteoporosis treated with raloxifene: results from a 3-year randomized clinical trial.JAMA282637645, for the Multiple Outcomes of Raloxifene Evaluation (MORE) InvestigatorsPubMed
24.
go back to reference Delmas, PD 2002Different effects of antiresorptive therapies on vertebral and nonvertebral fractures in postmenopausal osteoporosis.Bone301417CrossRefPubMed Delmas, PD 2002Different effects of antiresorptive therapies on vertebral and nonvertebral fractures in postmenopausal osteoporosis.Bone301417CrossRefPubMed
25.
go back to reference Black, DM, Arden, NK, Palermo, L, Pearson, J, Cummings, SR 1999Prevalent vertebral deformities predict hip fractures and new vertebral deformities but not wrist fractures.J Bone Miner Res14821828, for the Study of Osteoporotic Fractures Research GroupPubMed Black, DM, Arden, NK, Palermo, L, Pearson, J, Cummings, SR 1999Prevalent vertebral deformities predict hip fractures and new vertebral deformities but not wrist fractures.J Bone Miner Res14821828, for the Study of Osteoporotic Fractures Research GroupPubMed
26.
go back to reference Ross, PD, Davis, JW, Epstein, RS, Wasnich, RD 1991Pre-existing fractures and bone mass predict vertebral fracture incidence in women.Ann Intern Med114919923PubMed Ross, PD, Davis, JW, Epstein, RS, Wasnich, RD 1991Pre-existing fractures and bone mass predict vertebral fracture incidence in women.Ann Intern Med114919923PubMed
27.
go back to reference Lauritzen, JB, Lund, B 1993Risk of hip fracture after osteoporosis fractures: 451 women with fracture of lumbar spine, olecranon, knee or ankle.Acta Orthop Scand64297300PubMed Lauritzen, JB, Lund, B 1993Risk of hip fracture after osteoporosis fractures: 451 women with fracture of lumbar spine, olecranon, knee or ankle.Acta Orthop Scand64297300PubMed
28.
go back to reference Fujiwara, S, Kasagi, F, Yamada, M, Kodama, K 1997Risk factors for hip fracture in a Japanese cohort.J Bone Miner Res129981004 Fujiwara, S, Kasagi, F, Yamada, M, Kodama, K 1997Risk factors for hip fracture in a Japanese cohort.J Bone Miner Res129981004
29.
go back to reference Kotowicz, MA, Melton III, LJ, Cooper, C, Atkinson, EJ, O’Fallon, WM, Riggs, BL 1994Risk of hip fracture in women with vertebral fracture.J Bone Miner Res9599605PubMed Kotowicz, MA, Melton III, LJ, Cooper, C, Atkinson, EJ, O’Fallon, WM, Riggs, BL 1994Risk of hip fracture in women with vertebral fracture.J Bone Miner Res9599605PubMed
30.
go back to reference Cummings, SR, Kelsey, JL, Nevitt, MC, O’Dowd, KJ 1985Epidemiology of osteoporosis and osteoporotic fractures.Epidemiol Rev7178208PubMed Cummings, SR, Kelsey, JL, Nevitt, MC, O’Dowd, KJ 1985Epidemiology of osteoporosis and osteoporotic fractures.Epidemiol Rev7178208PubMed
31.
go back to reference Melton III, LJ, Cummings, SR 1987Heterogeneity of age-related fractures: implications for epidemiology.Bone Miner2321331 Melton III, LJ, Cummings, SR 1987Heterogeneity of age-related fractures: implications for epidemiology.Bone Miner2321331
32.
go back to reference Jones, G, Nguyen, T, Sambrook, PN, Kelly, PJ, Gilbert, C, Eisman, JA 1994Symptomatic fracture incidence in elderly men and women: the Dubbo Osteoporosis Epidemiology Study (DOES).Osteoporos Int4277282PubMed Jones, G, Nguyen, T, Sambrook, PN, Kelly, PJ, Gilbert, C, Eisman, JA 1994Symptomatic fracture incidence in elderly men and women: the Dubbo Osteoporosis Epidemiology Study (DOES).Osteoporos Int4277282PubMed
33.
go back to reference Donaldson, LJ, Cook, A, Thomson, RG 1990Incidence of fractures in a geographically defined population.J Epidemiol Community Health44241245PubMed Donaldson, LJ, Cook, A, Thomson, RG 1990Incidence of fractures in a geographically defined population.J Epidemiol Community Health44241245PubMed
34.
go back to reference Johansen, A, Evans, RJ, Stone, MD, Richmond, PW, Lo, SV, Woodhouse, KW 1997Fracture incidence in England and Wales: a study based on the population of Cardiff.Injury28655660CrossRefPubMed Johansen, A, Evans, RJ, Stone, MD, Richmond, PW, Lo, SV, Woodhouse, KW 1997Fracture incidence in England and Wales: a study based on the population of Cardiff.Injury28655660CrossRefPubMed
35.
go back to reference Ismail, AA, Cockerill, W, Cooper, C, et al. 2001Prevalent vertebral deformity predicts incident hip though not distal forearm fracture: results from the European Prospective Osteoporosis Study.Osteoporos Int128590CrossRefPubMed Ismail, AA, Cockerill, W, Cooper, C,  et al. 2001Prevalent vertebral deformity predicts incident hip though not distal forearm fracture: results from the European Prospective Osteoporosis Study.Osteoporos Int128590CrossRefPubMed
36.
go back to reference Watts, N, Bockman, R, Smith, C, Li, Z, Eastell, R, Pack, S, Lindsay, R 2000BMD change explains only a fraction of the observed fracture risk reduction in risedronate-treated patients (abstract).Osteoporosis Int11S203CrossRef Watts, N, Bockman, R, Smith, C, Li, Z, Eastell, R, Pack, S, Lindsay, R 2000BMD change explains only a fraction of the observed fracture risk reduction in risedronate-treated patients (abstract).Osteoporosis Int11S203CrossRef
37.
go back to reference Li, Z, Meredith, MP, Hoseyni, MS 2001A method to assess the proportion of treatment effect explained by a surrogate endpoint.Stat Med2031753188CrossRefPubMed Li, Z, Meredith, MP, Hoseyni, MS 2001A method to assess the proportion of treatment effect explained by a surrogate endpoint.Stat Med2031753188CrossRefPubMed
38.
go back to reference Cummings, SR, Black, DM, Pearson, JB, Karpf, DB, Harris, F, Genant, HK, LaCroix, AZ 1999How much of the reduction in risk of vertebral fractures by alendronate is explained by increased spine BMD? (abstract).J Bone Miner Res14SI59 Cummings, SR, Black, DM, Pearson, JB, Karpf, DB, Harris, F, Genant, HK, LaCroix, AZ 1999How much of the reduction in risk of vertebral fractures by alendronate is explained by increased spine BMD? (abstract).J Bone Miner Res14SI59
39.
go back to reference Sarkar, S, Mitlak, BH, Wong, M, Stock, JL, Black, DM, Harper, KD 2002Relationships between bone mineral density and incident vertebral fracture risk with raloxifene therapy.J Bone Miner Res17110PubMed Sarkar, S, Mitlak, BH, Wong, M, Stock, JL, Black, DM, Harper, KD 2002Relationships between bone mineral density and incident vertebral fracture risk with raloxifene therapy.J Bone Miner Res17110PubMed
40.
go back to reference van Staa, TP, Dennison, EM, Leufkens, HG, Cooper, C 2001Epidemiology of fractures in England and Wales.Bone29517522CrossRefPubMed van Staa, TP, Dennison, EM, Leufkens, HG, Cooper, C 2001Epidemiology of fractures in England and Wales.Bone29517522CrossRefPubMed
41.
go back to reference Cummings, SR, Nevitt, MC, Browner, WS, Stone, K, Fox, KM, Ensrud, KE, Cauley, J, Black, D, Vogt, TM 1995Risk factors for hip fracture in white women.N Engl J Med332767773, the Study of Osteoporotic Fractures Research GroupPubMed Cummings, SR, Nevitt, MC, Browner, WS, Stone, K, Fox, KM, Ensrud, KE, Cauley, J, Black, D, Vogt, TM 1995Risk factors for hip fracture in white women.N Engl J Med332767773, the Study of Osteoporotic Fractures Research GroupPubMed
Metadata
Title
Risedronate Rapidly Reduces the Risk for Nonvertebral Fractures in Women with Postmenopausal Osteoporosis
Authors
J. T. Harrington
L. -G. Ste-Marie
M. L. Brandi
R. Civitelli
P. Fardellone
A. Grauer
I. Barton
S. Boonen
Publication date
01-04-2004
Publisher
Springer-Verlag
Published in
Calcified Tissue International / Issue 2/2004
Print ISSN: 0171-967X
Electronic ISSN: 1432-0827
DOI
https://doi.org/10.1007/s00223-003-0042-4

Other articles of this Issue 2/2004

Calcified Tissue International 2/2004 Go to the issue

Laboratory Investigations

Erratum

Live Webinar | 27-06-2024 | 18:00 (CEST)

Keynote webinar | Spotlight on medication adherence

Live: Thursday 27th June 2024, 18:00-19:30 (CEST)

WHO estimates that half of all patients worldwide are non-adherent to their prescribed medication. The consequences of poor adherence can be catastrophic, on both the individual and population level.

Join our expert panel to discover why you need to understand the drivers of non-adherence in your patients, and how you can optimize medication adherence in your clinics to drastically improve patient outcomes.

Prof. Kevin Dolgin
Prof. Florian Limbourg
Prof. Anoop Chauhan
Developed by: Springer Medicine
Obesity Clinical Trial Summary

At a glance: The STEP trials

A round-up of the STEP phase 3 clinical trials evaluating semaglutide for weight loss in people with overweight or obesity.

Developed by: Springer Medicine

Highlights from the ACC 2024 Congress

Year in Review: Pediatric cardiology

Watch Dr. Anne Marie Valente present the last year's highlights in pediatric and congenital heart disease in the official ACC.24 Year in Review session.

Year in Review: Pulmonary vascular disease

The last year's highlights in pulmonary vascular disease are presented by Dr. Jane Leopold in this official video from ACC.24.

Year in Review: Valvular heart disease

Watch Prof. William Zoghbi present the last year's highlights in valvular heart disease from the official ACC.24 Year in Review session.

Year in Review: Heart failure and cardiomyopathies

Watch this official video from ACC.24. Dr. Biykem Bozkurt discusses last year's major advances in heart failure and cardiomyopathies.