Comparative effects of raloxifene and alendronate on fracture outcomes in postmenopausal women with low bone mass

Robert R. Recker, David Kendler, Christopher P. Recknor, Theodore W. Rooney, E. Michael Lewiecki, Wulf H. Utian, Jane A. Cauley, Joanne Lorraine, Yongming Qu, Pandurang M. Kulkarni, Carol L. Gaich, Mayme Wong, Leo Plouffe, John L. Stock

Research output: Contribution to journalArticle

40 Citations (Scopus)

Abstract

The double-blind, randomized raloxifene alendronate comparison trial was the first study designed to compare two osteoporosis therapies head-to-head for fracture risk reduction. The original protocol planned to treat 3000 postmenopausal women with alendronate 10 mg/day (ALN) or raloxifene 60 mg/day (RLX) for 5 years, and to recruit women (50-80 years old) with a femoral neck bone mineral density (BMD) T-score between - 2.5 and - 4.0, inclusive, no prevalent vertebral fractures, and no prior bone-active agent use. The trial was stopped early, due to difficulty in finding treatment-naïve women to meet enrollment goals within the planned timeline, resulting in insufficient power to show non-inferiority between therapies in the primary endpoint (number of women with ≥ 1 new osteoporotic vertebral or nonvertebral fracture). Except for vertebral fractures, fracture analyses were based upon 1412 of the 1423 women randomized (mean age of 66 years). After 312 ± 254 days (mean ± SD), 22 women in the ALN group and 20 in the RLX group had new vertebral or nonvertebral fractures. Four women in the ALN group and none in the RLX group had moderate/severe vertebral fractures, a pre-specified endpoint (P = 0.04). Lumbar spine, femoral neck, and total hip BMD were increased from baseline at 2 years in each group (P <0.001), with greater increases in the ALN group (each P <0.05). Similar numbers of women in each group had ≥ 1 adverse event and discontinued due to an adverse event. The only adverse events with an incidence that differed between groups were colonoscopy, diarrhea, and nausea; each was more common with ALN treatment (each P <0.05). One woman in each group had a venous thromboembolic event. One case of breast cancer occurred in each group. In summary, as this trial was terminated early, there was insufficient power to compare the fracture risks between alendronate and raloxifene. Safety profiles were as expected from clinical trial and post-marketing reports. Trial Registration: ClinicalTrials.gov Identifier NCT00035971.

Original languageEnglish
Pages (from-to)843-851
Number of pages9
JournalBone
Volume40
Issue number4
DOIs
StatePublished - Apr 2007

Fingerprint

Alendronate
Bone and Bones
Femur Neck
Bone Density
Pelvic Bones
Raloxifene Hydrochloride
Fracture Fixation
Risk Reduction Behavior
Colonoscopy
Therapeutics
Marketing
Nausea
Osteoporosis
Diarrhea
Spine
Clinical Trials
Breast Neoplasms
Safety

All Science Journal Classification (ASJC) codes

  • Physiology
  • Hematology

Cite this

Recker, R. R., Kendler, D., Recknor, C. P., Rooney, T. W., Lewiecki, E. M., Utian, W. H., ... Stock, J. L. (2007). Comparative effects of raloxifene and alendronate on fracture outcomes in postmenopausal women with low bone mass. Bone, 40(4), 843-851. https://doi.org/10.1016/j.bone.2006.11.001

Comparative effects of raloxifene and alendronate on fracture outcomes in postmenopausal women with low bone mass. / Recker, Robert R.; Kendler, David; Recknor, Christopher P.; Rooney, Theodore W.; Lewiecki, E. Michael; Utian, Wulf H.; Cauley, Jane A.; Lorraine, Joanne; Qu, Yongming; Kulkarni, Pandurang M.; Gaich, Carol L.; Wong, Mayme; Plouffe, Leo; Stock, John L.

In: Bone, Vol. 40, No. 4, 04.2007, p. 843-851.

Research output: Contribution to journalArticle

Recker, RR, Kendler, D, Recknor, CP, Rooney, TW, Lewiecki, EM, Utian, WH, Cauley, JA, Lorraine, J, Qu, Y, Kulkarni, PM, Gaich, CL, Wong, M, Plouffe, L & Stock, JL 2007, 'Comparative effects of raloxifene and alendronate on fracture outcomes in postmenopausal women with low bone mass', Bone, vol. 40, no. 4, pp. 843-851. https://doi.org/10.1016/j.bone.2006.11.001
Recker, Robert R. ; Kendler, David ; Recknor, Christopher P. ; Rooney, Theodore W. ; Lewiecki, E. Michael ; Utian, Wulf H. ; Cauley, Jane A. ; Lorraine, Joanne ; Qu, Yongming ; Kulkarni, Pandurang M. ; Gaich, Carol L. ; Wong, Mayme ; Plouffe, Leo ; Stock, John L. / Comparative effects of raloxifene and alendronate on fracture outcomes in postmenopausal women with low bone mass. In: Bone. 2007 ; Vol. 40, No. 4. pp. 843-851.
@article{62b5d6d5e47c4ab8a0ad00523d25ff00,
title = "Comparative effects of raloxifene and alendronate on fracture outcomes in postmenopausal women with low bone mass",
abstract = "The double-blind, randomized raloxifene alendronate comparison trial was the first study designed to compare two osteoporosis therapies head-to-head for fracture risk reduction. The original protocol planned to treat 3000 postmenopausal women with alendronate 10 mg/day (ALN) or raloxifene 60 mg/day (RLX) for 5 years, and to recruit women (50-80 years old) with a femoral neck bone mineral density (BMD) T-score between - 2.5 and - 4.0, inclusive, no prevalent vertebral fractures, and no prior bone-active agent use. The trial was stopped early, due to difficulty in finding treatment-na{\"i}ve women to meet enrollment goals within the planned timeline, resulting in insufficient power to show non-inferiority between therapies in the primary endpoint (number of women with ≥ 1 new osteoporotic vertebral or nonvertebral fracture). Except for vertebral fractures, fracture analyses were based upon 1412 of the 1423 women randomized (mean age of 66 years). After 312 ± 254 days (mean ± SD), 22 women in the ALN group and 20 in the RLX group had new vertebral or nonvertebral fractures. Four women in the ALN group and none in the RLX group had moderate/severe vertebral fractures, a pre-specified endpoint (P = 0.04). Lumbar spine, femoral neck, and total hip BMD were increased from baseline at 2 years in each group (P <0.001), with greater increases in the ALN group (each P <0.05). Similar numbers of women in each group had ≥ 1 adverse event and discontinued due to an adverse event. The only adverse events with an incidence that differed between groups were colonoscopy, diarrhea, and nausea; each was more common with ALN treatment (each P <0.05). One woman in each group had a venous thromboembolic event. One case of breast cancer occurred in each group. In summary, as this trial was terminated early, there was insufficient power to compare the fracture risks between alendronate and raloxifene. Safety profiles were as expected from clinical trial and post-marketing reports. Trial Registration: ClinicalTrials.gov Identifier NCT00035971.",
author = "Recker, {Robert R.} and David Kendler and Recknor, {Christopher P.} and Rooney, {Theodore W.} and Lewiecki, {E. Michael} and Utian, {Wulf H.} and Cauley, {Jane A.} and Joanne Lorraine and Yongming Qu and Kulkarni, {Pandurang M.} and Gaich, {Carol L.} and Mayme Wong and Leo Plouffe and Stock, {John L.}",
year = "2007",
month = "4",
doi = "10.1016/j.bone.2006.11.001",
language = "English",
volume = "40",
pages = "843--851",
journal = "Bone",
issn = "8756-3282",
publisher = "Elsevier Inc.",
number = "4",

}

TY - JOUR

T1 - Comparative effects of raloxifene and alendronate on fracture outcomes in postmenopausal women with low bone mass

AU - Recker, Robert R.

AU - Kendler, David

AU - Recknor, Christopher P.

AU - Rooney, Theodore W.

AU - Lewiecki, E. Michael

AU - Utian, Wulf H.

AU - Cauley, Jane A.

AU - Lorraine, Joanne

AU - Qu, Yongming

AU - Kulkarni, Pandurang M.

AU - Gaich, Carol L.

AU - Wong, Mayme

AU - Plouffe, Leo

AU - Stock, John L.

PY - 2007/4

Y1 - 2007/4

N2 - The double-blind, randomized raloxifene alendronate comparison trial was the first study designed to compare two osteoporosis therapies head-to-head for fracture risk reduction. The original protocol planned to treat 3000 postmenopausal women with alendronate 10 mg/day (ALN) or raloxifene 60 mg/day (RLX) for 5 years, and to recruit women (50-80 years old) with a femoral neck bone mineral density (BMD) T-score between - 2.5 and - 4.0, inclusive, no prevalent vertebral fractures, and no prior bone-active agent use. The trial was stopped early, due to difficulty in finding treatment-naïve women to meet enrollment goals within the planned timeline, resulting in insufficient power to show non-inferiority between therapies in the primary endpoint (number of women with ≥ 1 new osteoporotic vertebral or nonvertebral fracture). Except for vertebral fractures, fracture analyses were based upon 1412 of the 1423 women randomized (mean age of 66 years). After 312 ± 254 days (mean ± SD), 22 women in the ALN group and 20 in the RLX group had new vertebral or nonvertebral fractures. Four women in the ALN group and none in the RLX group had moderate/severe vertebral fractures, a pre-specified endpoint (P = 0.04). Lumbar spine, femoral neck, and total hip BMD were increased from baseline at 2 years in each group (P <0.001), with greater increases in the ALN group (each P <0.05). Similar numbers of women in each group had ≥ 1 adverse event and discontinued due to an adverse event. The only adverse events with an incidence that differed between groups were colonoscopy, diarrhea, and nausea; each was more common with ALN treatment (each P <0.05). One woman in each group had a venous thromboembolic event. One case of breast cancer occurred in each group. In summary, as this trial was terminated early, there was insufficient power to compare the fracture risks between alendronate and raloxifene. Safety profiles were as expected from clinical trial and post-marketing reports. Trial Registration: ClinicalTrials.gov Identifier NCT00035971.

AB - The double-blind, randomized raloxifene alendronate comparison trial was the first study designed to compare two osteoporosis therapies head-to-head for fracture risk reduction. The original protocol planned to treat 3000 postmenopausal women with alendronate 10 mg/day (ALN) or raloxifene 60 mg/day (RLX) for 5 years, and to recruit women (50-80 years old) with a femoral neck bone mineral density (BMD) T-score between - 2.5 and - 4.0, inclusive, no prevalent vertebral fractures, and no prior bone-active agent use. The trial was stopped early, due to difficulty in finding treatment-naïve women to meet enrollment goals within the planned timeline, resulting in insufficient power to show non-inferiority between therapies in the primary endpoint (number of women with ≥ 1 new osteoporotic vertebral or nonvertebral fracture). Except for vertebral fractures, fracture analyses were based upon 1412 of the 1423 women randomized (mean age of 66 years). After 312 ± 254 days (mean ± SD), 22 women in the ALN group and 20 in the RLX group had new vertebral or nonvertebral fractures. Four women in the ALN group and none in the RLX group had moderate/severe vertebral fractures, a pre-specified endpoint (P = 0.04). Lumbar spine, femoral neck, and total hip BMD were increased from baseline at 2 years in each group (P <0.001), with greater increases in the ALN group (each P <0.05). Similar numbers of women in each group had ≥ 1 adverse event and discontinued due to an adverse event. The only adverse events with an incidence that differed between groups were colonoscopy, diarrhea, and nausea; each was more common with ALN treatment (each P <0.05). One woman in each group had a venous thromboembolic event. One case of breast cancer occurred in each group. In summary, as this trial was terminated early, there was insufficient power to compare the fracture risks between alendronate and raloxifene. Safety profiles were as expected from clinical trial and post-marketing reports. Trial Registration: ClinicalTrials.gov Identifier NCT00035971.

UR - http://www.scopus.com/inward/record.url?scp=33847694771&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=33847694771&partnerID=8YFLogxK

U2 - 10.1016/j.bone.2006.11.001

DO - 10.1016/j.bone.2006.11.001

M3 - Article

C2 - 17182297

AN - SCOPUS:33847694771

VL - 40

SP - 843

EP - 851

JO - Bone

JF - Bone

SN - 8756-3282

IS - 4

ER -