The University of Southampton
University of Southampton Institutional Repository

Efficacy and safety of oral weekly ibandronate in the treatment of postmenopausal osteoporosis

Efficacy and safety of oral weekly ibandronate in the treatment of postmenopausal osteoporosis
Efficacy and safety of oral weekly ibandronate in the treatment of postmenopausal osteoporosis
Adherence to oral daily bisphosphonate regimens in postmenopausal osteoporosis is currently suboptimal. Less frequent dosing regimens are likely to improve patient adherence and thus, potentially, patient outcomes. A multicenter, randomized, double-blind, noninferiority study was conducted in 235 women (53–80 yr old; time since menopause 3 yr) with postmenopausal osteoporosis [lumbar spine (L1-L4) bone mineral density (BMD) T-score -2] to demonstrate the noninferiority of an oral weekly (20 mg) ibandronate regimen compared with an oral daily (2.5 mg) ibandronate regimen. All patients received daily calcium (500 mg) and vitamin D (400 IU). The primary analysis was the relative change in lumbar spine (L1-L4) BMD from baseline after 48 wk in the per- protocol population. Daily and weekly ibandronate significantly increased spinal BMD by 3.47 and 3.53%, respectively, and provided substantial and similar decreases in biochemical markers of bone turnover. In the primary analysis, noninferiority of the weekly regimen to the daily regimen was demonstrated, with the boundary of the one-sided confidence interval, -0.96%, within both the -1.65% prespecified margin and a more stringent margin of -1.10%. These results demonstrate that oral weekly ibandronate provides the same efficacy and safety as oral daily ibandronate in women with postmenopausal osteoporosis.
0021-972X
4609-4615
Cooper, Cyrus
e05f5612-b493-4273-9b71-9e0ce32bdad6
Emkey, Ronald D.
f0249fde-e2f3-4587-811b-3318e7270a03
McDonald, Robert H.
9811f3c7-7b50-413c-95c6-0b40311de3c5
Hawker, Gillian
f9b41fa2-d293-473e-b86a-7e6ee2ae1a89
Bianchi, Gerolamo
641959d9-1bda-486b-949b-be02e94bc74c
Wilson, Katie
8d08c2ac-3b7c-4a9e-91cf-c4ceab011c41
Schimmer, Ralph C.
e6c056da-35d5-46fe-abbc-720ea1003a1c
Cooper, Cyrus
e05f5612-b493-4273-9b71-9e0ce32bdad6
Emkey, Ronald D.
f0249fde-e2f3-4587-811b-3318e7270a03
McDonald, Robert H.
9811f3c7-7b50-413c-95c6-0b40311de3c5
Hawker, Gillian
f9b41fa2-d293-473e-b86a-7e6ee2ae1a89
Bianchi, Gerolamo
641959d9-1bda-486b-949b-be02e94bc74c
Wilson, Katie
8d08c2ac-3b7c-4a9e-91cf-c4ceab011c41
Schimmer, Ralph C.
e6c056da-35d5-46fe-abbc-720ea1003a1c

Cooper, Cyrus, Emkey, Ronald D., McDonald, Robert H., Hawker, Gillian, Bianchi, Gerolamo, Wilson, Katie and Schimmer, Ralph C. (2003) Efficacy and safety of oral weekly ibandronate in the treatment of postmenopausal osteoporosis. Journal of Clinical Endocrinology and Metabolism, 88 (10), 4609-4615. (doi:10.1210/jc.2003-022029).

Record type: Article

Abstract

Adherence to oral daily bisphosphonate regimens in postmenopausal osteoporosis is currently suboptimal. Less frequent dosing regimens are likely to improve patient adherence and thus, potentially, patient outcomes. A multicenter, randomized, double-blind, noninferiority study was conducted in 235 women (53–80 yr old; time since menopause 3 yr) with postmenopausal osteoporosis [lumbar spine (L1-L4) bone mineral density (BMD) T-score -2] to demonstrate the noninferiority of an oral weekly (20 mg) ibandronate regimen compared with an oral daily (2.5 mg) ibandronate regimen. All patients received daily calcium (500 mg) and vitamin D (400 IU). The primary analysis was the relative change in lumbar spine (L1-L4) BMD from baseline after 48 wk in the per- protocol population. Daily and weekly ibandronate significantly increased spinal BMD by 3.47 and 3.53%, respectively, and provided substantial and similar decreases in biochemical markers of bone turnover. In the primary analysis, noninferiority of the weekly regimen to the daily regimen was demonstrated, with the boundary of the one-sided confidence interval, -0.96%, within both the -1.65% prespecified margin and a more stringent margin of -1.10%. These results demonstrate that oral weekly ibandronate provides the same efficacy and safety as oral daily ibandronate in women with postmenopausal osteoporosis.

Full text not available from this repository.

More information

Published date: 2003

Identifiers

Local EPrints ID: 25380
URI: https://eprints.soton.ac.uk/id/eprint/25380
ISSN: 0021-972X
PURE UUID: 4a63724b-7094-40d9-b3aa-7bbf8baa2d78
ORCID for Cyrus Cooper: ORCID iD orcid.org/0000-0003-3510-0709

Catalogue record

Date deposited: 12 Apr 2006
Last modified: 06 Jun 2018 12:59

Export record

Altmetrics

Download statistics

Downloads from ePrints over the past year. Other digital versions may also be available to download e.g. from the publisher's website.

View more statistics

Atom RSS 1.0 RSS 2.0

Contact ePrints Soton: eprints@soton.ac.uk

ePrints Soton supports OAI 2.0 with a base URL of https://eprints.soton.ac.uk/cgi/oai2

This repository has been built using EPrints software, developed at the University of Southampton, but available to everyone to use.

We use cookies to ensure that we give you the best experience on our website. If you continue without changing your settings, we will assume that you are happy to receive cookies on the University of Southampton website.

×