Ibrandronate for the prevention of non-vertebral fractures: a pooled analysis of individual-patient data
Ibrandronate for the prevention of non-vertebral fractures: a pooled analysis of individual-patient data
Summary: this analysis was conducted to assess the effect of high versus lower doses of ibandronate on nonvertebral fractures. The results were adjusted for clinical fracture, age, and bone density. The treatment effect was dose-dependent. Higher doses of ibandronate significantly reduced the risk of nonvertebral fractures more effectively compared with lower doses.
Introduction: the objective of this study was to assess the efficacy of different doses of ibandronate on nonvertebral fractures in a pooled analysis.
Methods: eight randomized trials of ibandronate were reviewed for inclusion. Alternative definitions of high versus low doses based on annual cumulative exposure (ACE) were explored. A time-to-event analysis was conducted using Kaplan–Meier methodology. Hazard ratios (HR) were derived using Cox regression and adjusted for covariates.
Results: combining higher ACE doses of ? 10.8 mg (150 mg once monthly, 3 mg i.v. quarterly, and 2 mg i.v. every 2 months) versus ACE doses of 5.5 mg, from two trials, resulted in an HR 0.62 (95% CI 0.396–0.974, p?=?0.038). There was a dose–response trend with increasing ACE doses (7.2–12 mg) versus ACE of 5.5 mg.
Conclusions: a dose–response effect on nonvertebral fractures was observed when comparing high with low ACE doses. A significant reduction in nonvertebral fractures was noted when pooling data from trials using ACE doses of ? 10.8 mg versus ACE ? 7.2 mg; and with ACE ? 10.8 mg versus ACE of 5.5 mg (38% reduction). Higher ibandronate dose levels (150 mg monthly or 3 mg i.v. quarterly) significantly reduced nonvertebral fracture risk in postmenopausal women
ibandronate, nonvertebral fractures, postmenopausal osteoporosis
291-297
Cranney, A.
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Wells, G.A.
2af58a7a-ff46-4139-be76-a8871a8a31fc
Yetisir, L.
37f9c650-ed5a-4cb1-9e78-04ee957451ef
Adami, S.
4e8b8772-f6ad-4ed6-8629-6ed35cd921fd
Cooper, C.
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Delmas, P.D.
f1454c14-9506-42f9-a989-bcb82ffbec46
Miller, P. D.
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Papapoulos, S.
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Reginster, J.-Y.
8b548609-99db-46ae-a28a-7967ba8c7483
Sambrook, P.
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Silverman, S.
dfe0f214-17ef-41de-b403-7e2b3105f178
Siris, E.
34f296f5-0065-4bdd-9656-28db3a86b331
Adachi, J.D.
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February 2009
Cranney, A.
30c9f0db-bea3-4bb0-8150-9bf897dcfe8d
Wells, G.A.
2af58a7a-ff46-4139-be76-a8871a8a31fc
Yetisir, L.
37f9c650-ed5a-4cb1-9e78-04ee957451ef
Adami, S.
4e8b8772-f6ad-4ed6-8629-6ed35cd921fd
Cooper, C.
e05f5612-b493-4273-9b71-9e0ce32bdad6
Delmas, P.D.
f1454c14-9506-42f9-a989-bcb82ffbec46
Miller, P. D.
f332d54c-7f95-4972-891a-8ea1dbf564b0
Papapoulos, S.
3d3fba2f-7d1e-477d-ac7d-3bbd2ae73cd4
Reginster, J.-Y.
8b548609-99db-46ae-a28a-7967ba8c7483
Sambrook, P.
17fed862-0ad3-4bb9-8e6d-1474e8308da5
Silverman, S.
dfe0f214-17ef-41de-b403-7e2b3105f178
Siris, E.
34f296f5-0065-4bdd-9656-28db3a86b331
Adachi, J.D.
fad23249-519e-4d11-ac21-f42742cd19fb
Cranney, A., Wells, G.A., Yetisir, L., Adami, S., Cooper, C., Delmas, P.D., Miller, P. D., Papapoulos, S., Reginster, J.-Y., Sambrook, P., Silverman, S., Siris, E. and Adachi, J.D.
(2009)
Ibrandronate for the prevention of non-vertebral fractures: a pooled analysis of individual-patient data.
Osteoporosis International, 20 (2), .
(doi:10.1007/s00198-008-0653-8).
Abstract
Summary: this analysis was conducted to assess the effect of high versus lower doses of ibandronate on nonvertebral fractures. The results were adjusted for clinical fracture, age, and bone density. The treatment effect was dose-dependent. Higher doses of ibandronate significantly reduced the risk of nonvertebral fractures more effectively compared with lower doses.
Introduction: the objective of this study was to assess the efficacy of different doses of ibandronate on nonvertebral fractures in a pooled analysis.
Methods: eight randomized trials of ibandronate were reviewed for inclusion. Alternative definitions of high versus low doses based on annual cumulative exposure (ACE) were explored. A time-to-event analysis was conducted using Kaplan–Meier methodology. Hazard ratios (HR) were derived using Cox regression and adjusted for covariates.
Results: combining higher ACE doses of ? 10.8 mg (150 mg once monthly, 3 mg i.v. quarterly, and 2 mg i.v. every 2 months) versus ACE doses of 5.5 mg, from two trials, resulted in an HR 0.62 (95% CI 0.396–0.974, p?=?0.038). There was a dose–response trend with increasing ACE doses (7.2–12 mg) versus ACE of 5.5 mg.
Conclusions: a dose–response effect on nonvertebral fractures was observed when comparing high with low ACE doses. A significant reduction in nonvertebral fractures was noted when pooling data from trials using ACE doses of ? 10.8 mg versus ACE ? 7.2 mg; and with ACE ? 10.8 mg versus ACE of 5.5 mg (38% reduction). Higher ibandronate dose levels (150 mg monthly or 3 mg i.v. quarterly) significantly reduced nonvertebral fracture risk in postmenopausal women
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More information
Published date: February 2009
Keywords:
ibandronate, nonvertebral fractures, postmenopausal osteoporosis
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Local EPrints ID: 68864
URI: http://eprints.soton.ac.uk/id/eprint/68864
ISSN: 0937-941X
PURE UUID: 68009f37-2747-476b-b25c-98ad165d2782
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Date deposited: 07 Oct 2009
Last modified: 18 Mar 2024 02:44
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Contributors
Author:
A. Cranney
Author:
G.A. Wells
Author:
L. Yetisir
Author:
S. Adami
Author:
P.D. Delmas
Author:
P. D. Miller
Author:
S. Papapoulos
Author:
J.-Y. Reginster
Author:
P. Sambrook
Author:
S. Silverman
Author:
E. Siris
Author:
J.D. Adachi
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