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Long-term efficacy of risedronate: a 5-year placebo-controlled clinical experience

Long-term efficacy of risedronate: a 5-year placebo-controlled clinical experience
Long-term efficacy of risedronate: a 5-year placebo-controlled clinical experience
Limited placebo-controlled data are available to assess the long-term fracture efficacy of bisphosphonates. In order to determine the effects of 5 years of risedronate treatment, we extended a 3-year, placebo-controlled vertebral fracture study in osteoporotic women for an additional 2 years; women who entered the extension study continued to receive 5 mg risedronate or placebo according to the original randomization, with maintenance of blinding. End points included vertebral and nonvertebral fracture assessments, bone mineral density measurements, and changes in biochemical markers of bone turnover. A total of 265 women (placebo, 130; 5 mg risedronate, 135) entered the study extension and 220 (83%) completed the additional 2 years. Fracture results observed in the study extension were consistent with those observed in the first 3 years. The risk of new vertebral fractures was significantly reduced with risedronate treatment in years 4 and 5 by 59% (95% confidence interval, 19 to 79%, P = 0.01) compared with a 49% reduction in the first 3 years. Rapid and significant decreases in markers of bone turnover observed in the first 3 years were similarly maintained in the next 2 years of treatment. Increases in spine and hip bone mineral density that occurred in the risedronate group during the first 3 years were maintained or increased with a further 2 years of treatment. The mean increase from baseline in lumbar spine BMD over 5 years was 9.3% (P < 0.001). This study demonstrates that the effects of risedronate over 3 years on vertebral fracture and BMD are maintained with a further 2 years of treatment.
Bisphosphonate, Bone mineral density, Postmenopausal osteoporosis, Risedronate, Vertebral fracture
8756-3282
120-126
Sorensen, O. H.
ccd4129f-02c5-434b-9acd-5a953612bed0
Crawford, G. M.
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Mulder, H.
c3933457-0ac9-45eb-ab66-8604b738c113
Hosking, D. J.
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Gennari, C.
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Mellstrom, D.
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Pack, S.
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Wenderoth, D.
a303c32f-137d-479a-bde0-555c3f6f2d97
Cooper, C.
e05f5612-b493-4273-9b71-9e0ce32bdad6
Reginster, J. Y.
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Sorensen, O. H.
ccd4129f-02c5-434b-9acd-5a953612bed0
Crawford, G. M.
c5025782-28b7-4fd3-b10f-389660f4b1cd
Mulder, H.
c3933457-0ac9-45eb-ab66-8604b738c113
Hosking, D. J.
c06e955a-54b4-4ee4-9289-119b904ae2e4
Gennari, C.
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Mellstrom, D.
43d24c2f-97e4-423a-acec-6a13b3d477d9
Pack, S.
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Wenderoth, D.
a303c32f-137d-479a-bde0-555c3f6f2d97
Cooper, C.
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Reginster, J. Y.
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Sorensen, O. H., Crawford, G. M., Mulder, H., Hosking, D. J., Gennari, C., Mellstrom, D., Pack, S., Wenderoth, D., Cooper, C. and Reginster, J. Y. (2003) Long-term efficacy of risedronate: a 5-year placebo-controlled clinical experience. Bone, 32 (2), 120-126. (doi:10.1016/S8756-3282(02)00946-8).

Record type: Article

Abstract

Limited placebo-controlled data are available to assess the long-term fracture efficacy of bisphosphonates. In order to determine the effects of 5 years of risedronate treatment, we extended a 3-year, placebo-controlled vertebral fracture study in osteoporotic women for an additional 2 years; women who entered the extension study continued to receive 5 mg risedronate or placebo according to the original randomization, with maintenance of blinding. End points included vertebral and nonvertebral fracture assessments, bone mineral density measurements, and changes in biochemical markers of bone turnover. A total of 265 women (placebo, 130; 5 mg risedronate, 135) entered the study extension and 220 (83%) completed the additional 2 years. Fracture results observed in the study extension were consistent with those observed in the first 3 years. The risk of new vertebral fractures was significantly reduced with risedronate treatment in years 4 and 5 by 59% (95% confidence interval, 19 to 79%, P = 0.01) compared with a 49% reduction in the first 3 years. Rapid and significant decreases in markers of bone turnover observed in the first 3 years were similarly maintained in the next 2 years of treatment. Increases in spine and hip bone mineral density that occurred in the risedronate group during the first 3 years were maintained or increased with a further 2 years of treatment. The mean increase from baseline in lumbar spine BMD over 5 years was 9.3% (P < 0.001). This study demonstrates that the effects of risedronate over 3 years on vertebral fracture and BMD are maintained with a further 2 years of treatment.

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More information

Published date: 2003
Keywords: Bisphosphonate, Bone mineral density, Postmenopausal osteoporosis, Risedronate, Vertebral fracture

Identifiers

Local EPrints ID: 25990
URI: http://eprints.soton.ac.uk/id/eprint/25990
ISSN: 8756-3282
PURE UUID: dee4799b-dc85-48ae-87e9-663f78d94cd0
ORCID for C. Cooper: ORCID iD orcid.org/0000-0003-3510-0709

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Date deposited: 21 Apr 2006
Last modified: 18 Mar 2024 02:44

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Contributors

Author: O. H. Sorensen
Author: G. M. Crawford
Author: H. Mulder
Author: D. J. Hosking
Author: C. Gennari
Author: D. Mellstrom
Author: S. Pack
Author: D. Wenderoth
Author: C. Cooper ORCID iD
Author: J. Y. Reginster

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