Efficacy of raloxifene on vertebral fracture risk reduction in postmenopausal women with osteoporosis

Four-year results from a randomized clinical trial

Pierre D. Delmas, Kristine E. Ensrud, Jonathan D. Adachi, Kristine D. Harper, Somnath Sarkar, Carlo Gennari, Jean Yves Reginster, Huibert A P Pols, Robert R. Recker, Steven T. Harris, Wentao Wu, Harry K. Genant, Dennis M. Black, Richard Eastell

Research output: Contribution to journalArticle

471 Citations (Scopus)

Abstract

The Multiple Outcomes of Raloxifene Evaluation trial studied 7705 postmenopausal women with osteoporosis randomized to placebo, or raloxifene 60 or 120 mg/d [JAMA 282(1999):637]. This report assesses the efficacy of raloxifene on the long-term cumulative incidence new vertebral fractures through 4 yr. New vertebral fractures was assessed from radiographs taken at baseline, yr 2-4. The primary analysis was the cumulative incidence of new vertebral fractures through 4 yr. A posthoc analysis compared the vertebral fracture risk in yr 4 alone with that observed in the first 3 yr. The 4-yr cumulative relative risks (RR) for one or more new vertebral fractures were 0.64 [95% confidence interval (CI) 0.53, 0.76] with raloxifene 60 mg/d and 0.57 (95% CI 0.48, 0.69) with raloxifene 120 mg/d. In yr 4 alone, raloxifene 60 mg/d reduced the new vertebral fracture risk by 39% [RR 0.61 (95% CI 0.43, 0.88)], which was not found to be significantly different from the RR observed in the first 3 yr in both raloxifene groups, irrespective of prevalent fracture status. The nonvertebral fracture risk was not significantly reduced [RR 0.93 (95% CI 0.81, 1.06)]. The safety profile after 4 yr was similar to that observed after 3 yr. Raloxifene 60 and 120 mg/d through 4 yr decreased the cumulative risk of new vertebral fractures in postmenopausal women with osteoporosis. The decreased vertebral fracture risk in yr 4 alone was not different from that observed in the first 3 yr.

Original languageEnglish
Pages (from-to)3609-3617
Number of pages9
JournalJournal of Clinical Endocrinology and Metabolism
Volume87
Issue number8
DOIs
StatePublished - 2002

Fingerprint

Fracture Fixation
Risk Reduction Behavior
Osteoporosis
Randomized Controlled Trials
Confidence Intervals
Raloxifene Hydrochloride
Incidence
Placebos
Safety

All Science Journal Classification (ASJC) codes

  • Biochemistry
  • Endocrinology, Diabetes and Metabolism

Cite this

Efficacy of raloxifene on vertebral fracture risk reduction in postmenopausal women with osteoporosis : Four-year results from a randomized clinical trial. / Delmas, Pierre D.; Ensrud, Kristine E.; Adachi, Jonathan D.; Harper, Kristine D.; Sarkar, Somnath; Gennari, Carlo; Reginster, Jean Yves; Pols, Huibert A P; Recker, Robert R.; Harris, Steven T.; Wu, Wentao; Genant, Harry K.; Black, Dennis M.; Eastell, Richard.

In: Journal of Clinical Endocrinology and Metabolism, Vol. 87, No. 8, 2002, p. 3609-3617.

Research output: Contribution to journalArticle

Delmas, PD, Ensrud, KE, Adachi, JD, Harper, KD, Sarkar, S, Gennari, C, Reginster, JY, Pols, HAP, Recker, RR, Harris, ST, Wu, W, Genant, HK, Black, DM & Eastell, R 2002, 'Efficacy of raloxifene on vertebral fracture risk reduction in postmenopausal women with osteoporosis: Four-year results from a randomized clinical trial', Journal of Clinical Endocrinology and Metabolism, vol. 87, no. 8, pp. 3609-3617. https://doi.org/10.1210/jc.87.8.3609
Delmas, Pierre D. ; Ensrud, Kristine E. ; Adachi, Jonathan D. ; Harper, Kristine D. ; Sarkar, Somnath ; Gennari, Carlo ; Reginster, Jean Yves ; Pols, Huibert A P ; Recker, Robert R. ; Harris, Steven T. ; Wu, Wentao ; Genant, Harry K. ; Black, Dennis M. ; Eastell, Richard. / Efficacy of raloxifene on vertebral fracture risk reduction in postmenopausal women with osteoporosis : Four-year results from a randomized clinical trial. In: Journal of Clinical Endocrinology and Metabolism. 2002 ; Vol. 87, No. 8. pp. 3609-3617.
@article{ca50c6eca3c443e8b99c1c1967171f1f,
title = "Efficacy of raloxifene on vertebral fracture risk reduction in postmenopausal women with osteoporosis: Four-year results from a randomized clinical trial",
abstract = "The Multiple Outcomes of Raloxifene Evaluation trial studied 7705 postmenopausal women with osteoporosis randomized to placebo, or raloxifene 60 or 120 mg/d [JAMA 282(1999):637]. This report assesses the efficacy of raloxifene on the long-term cumulative incidence new vertebral fractures through 4 yr. New vertebral fractures was assessed from radiographs taken at baseline, yr 2-4. The primary analysis was the cumulative incidence of new vertebral fractures through 4 yr. A posthoc analysis compared the vertebral fracture risk in yr 4 alone with that observed in the first 3 yr. The 4-yr cumulative relative risks (RR) for one or more new vertebral fractures were 0.64 [95{\%} confidence interval (CI) 0.53, 0.76] with raloxifene 60 mg/d and 0.57 (95{\%} CI 0.48, 0.69) with raloxifene 120 mg/d. In yr 4 alone, raloxifene 60 mg/d reduced the new vertebral fracture risk by 39{\%} [RR 0.61 (95{\%} CI 0.43, 0.88)], which was not found to be significantly different from the RR observed in the first 3 yr in both raloxifene groups, irrespective of prevalent fracture status. The nonvertebral fracture risk was not significantly reduced [RR 0.93 (95{\%} CI 0.81, 1.06)]. The safety profile after 4 yr was similar to that observed after 3 yr. Raloxifene 60 and 120 mg/d through 4 yr decreased the cumulative risk of new vertebral fractures in postmenopausal women with osteoporosis. The decreased vertebral fracture risk in yr 4 alone was not different from that observed in the first 3 yr.",
author = "Delmas, {Pierre D.} and Ensrud, {Kristine E.} and Adachi, {Jonathan D.} and Harper, {Kristine D.} and Somnath Sarkar and Carlo Gennari and Reginster, {Jean Yves} and Pols, {Huibert A P} and Recker, {Robert R.} and Harris, {Steven T.} and Wentao Wu and Genant, {Harry K.} and Black, {Dennis M.} and Richard Eastell",
year = "2002",
doi = "10.1210/jc.87.8.3609",
language = "English",
volume = "87",
pages = "3609--3617",
journal = "Journal of Clinical Endocrinology and Metabolism",
issn = "0021-972X",
publisher = "The Endocrine Society",
number = "8",

}

TY - JOUR

T1 - Efficacy of raloxifene on vertebral fracture risk reduction in postmenopausal women with osteoporosis

T2 - Four-year results from a randomized clinical trial

AU - Delmas, Pierre D.

AU - Ensrud, Kristine E.

AU - Adachi, Jonathan D.

AU - Harper, Kristine D.

AU - Sarkar, Somnath

AU - Gennari, Carlo

AU - Reginster, Jean Yves

AU - Pols, Huibert A P

AU - Recker, Robert R.

AU - Harris, Steven T.

AU - Wu, Wentao

AU - Genant, Harry K.

AU - Black, Dennis M.

AU - Eastell, Richard

PY - 2002

Y1 - 2002

N2 - The Multiple Outcomes of Raloxifene Evaluation trial studied 7705 postmenopausal women with osteoporosis randomized to placebo, or raloxifene 60 or 120 mg/d [JAMA 282(1999):637]. This report assesses the efficacy of raloxifene on the long-term cumulative incidence new vertebral fractures through 4 yr. New vertebral fractures was assessed from radiographs taken at baseline, yr 2-4. The primary analysis was the cumulative incidence of new vertebral fractures through 4 yr. A posthoc analysis compared the vertebral fracture risk in yr 4 alone with that observed in the first 3 yr. The 4-yr cumulative relative risks (RR) for one or more new vertebral fractures were 0.64 [95% confidence interval (CI) 0.53, 0.76] with raloxifene 60 mg/d and 0.57 (95% CI 0.48, 0.69) with raloxifene 120 mg/d. In yr 4 alone, raloxifene 60 mg/d reduced the new vertebral fracture risk by 39% [RR 0.61 (95% CI 0.43, 0.88)], which was not found to be significantly different from the RR observed in the first 3 yr in both raloxifene groups, irrespective of prevalent fracture status. The nonvertebral fracture risk was not significantly reduced [RR 0.93 (95% CI 0.81, 1.06)]. The safety profile after 4 yr was similar to that observed after 3 yr. Raloxifene 60 and 120 mg/d through 4 yr decreased the cumulative risk of new vertebral fractures in postmenopausal women with osteoporosis. The decreased vertebral fracture risk in yr 4 alone was not different from that observed in the first 3 yr.

AB - The Multiple Outcomes of Raloxifene Evaluation trial studied 7705 postmenopausal women with osteoporosis randomized to placebo, or raloxifene 60 or 120 mg/d [JAMA 282(1999):637]. This report assesses the efficacy of raloxifene on the long-term cumulative incidence new vertebral fractures through 4 yr. New vertebral fractures was assessed from radiographs taken at baseline, yr 2-4. The primary analysis was the cumulative incidence of new vertebral fractures through 4 yr. A posthoc analysis compared the vertebral fracture risk in yr 4 alone with that observed in the first 3 yr. The 4-yr cumulative relative risks (RR) for one or more new vertebral fractures were 0.64 [95% confidence interval (CI) 0.53, 0.76] with raloxifene 60 mg/d and 0.57 (95% CI 0.48, 0.69) with raloxifene 120 mg/d. In yr 4 alone, raloxifene 60 mg/d reduced the new vertebral fracture risk by 39% [RR 0.61 (95% CI 0.43, 0.88)], which was not found to be significantly different from the RR observed in the first 3 yr in both raloxifene groups, irrespective of prevalent fracture status. The nonvertebral fracture risk was not significantly reduced [RR 0.93 (95% CI 0.81, 1.06)]. The safety profile after 4 yr was similar to that observed after 3 yr. Raloxifene 60 and 120 mg/d through 4 yr decreased the cumulative risk of new vertebral fractures in postmenopausal women with osteoporosis. The decreased vertebral fracture risk in yr 4 alone was not different from that observed in the first 3 yr.

UR - http://www.scopus.com/inward/record.url?scp=18544381541&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=18544381541&partnerID=8YFLogxK

U2 - 10.1210/jc.87.8.3609

DO - 10.1210/jc.87.8.3609

M3 - Article

VL - 87

SP - 3609

EP - 3617

JO - Journal of Clinical Endocrinology and Metabolism

JF - Journal of Clinical Endocrinology and Metabolism

SN - 0021-972X

IS - 8

ER -