CoChat
Sign Up
Cited by 1,229Bone health and osteoporosis researchBone health and treatmentsMenopause: Health Impacts and Treatments

The DOI matches its Crossref record; 42 of the 42 references it cites were found in a registry or an index.

Effects of Oral Ibandronate Administered Daily or Intermittently on Fracture Risk in Postmenopausal Osteoporosis

Open access
Chesnut, Charles H, Skag, Arne, Christiansen, Claus, Recker, Robert, Stakkestad, Jacob A, Hoiseth, Arne, Felsenberg, Dieter, Huss, Hermann, Gilbride, Jennifer, Schimmer, Ralph C, Delmas, Pierre D, for the Oral Ibandronate Osteoporosis Vertebral Fracture Trial in North America and Europe (BONE)·2004·Journal of Bone and Mineral Research
DOI 10.1359/jbmr.040325
Open this paper in CoChat — free accountOpen PDF

Abstract

Oral daily (2.5 mg) and intermittent ibandronate (between-dose interval of >2 months), delivering a similar cumulative exposure, were evaluated in 2946 osteoporotic women with prevalent vertebral fracture. Significant reduction in incident vertebral fracture risk by 62% and 50%, respectively, was shown after 3 years. This is the first study to prospectively show antifracture efficacy for the intermittent administration of a bisphosphonate. Introduction: Bisphosphonates are important therapeutics in postmenopausal osteoporosis. However, they are currently associated with stringent dosing instructions that may impair patient compliance and hence therapeutic efficacy. Less frequent, intermittent administration may help to overcome these deficiencies. This study assessed the efficacy and safety of oral ibandronate administered either daily or intermittently with a dose-free interval of >2 months. Materials and Methods: This randomized, double-blind, placebo-controlled, parallel-group study enrolled 2946 postmenopausal women with a BMD T score ≤ −2.0 at the lumbar spine in at least one vertebra (L1-L4) and one to four prevalent vertebral fractures (T4-L4). Patients received placebo or oral ibandronate administered either daily (2.5 mg) or intermittently (20 mg every other day for 12 doses every 3 months). Results and Conclusions: After 3 years, the rate of new vertebral fractures was significantly reduced in patients receiving oral daily (4.7%) and intermittent ibandronate (4.9%), relative to placebo (9.6%). Thus, daily and intermittent oral ibandronate significantly reduced the risk of new morphometric vertebral fractures by 62% (p = 0.0001) and 50% (p = 0.0006), respectively, versus placebo. Both treatment groups also produced a statistically significant relative risk reduction in clinical vertebral fractures (49% and 48% for daily and intermittent ibandronate, respectively). Significant and progressive increases in lumbar spine (6.5%, 5.7%, and 1.3% for daily ibandronate, intermittent ibandronate, and placebo, respectively, at 3 years) and hip BMD, normalization of bone turnover, and significantly less height loss than in the placebo group were also observed for both ibandronate regimens. The overall population was at low risk for osteoporotic fractures. Consequently, the incidence of nonvertebral fractures was similar between the ibandronate and placebo groups after 3 years (9.1%, 8.9%, and 8.2% in the daily, intermittent, and placebo groups, respectively; difference between arms not significant). However, findings from a posthoc analysis showed that the daily regimen reduces the risk of nonvertebral fractures (69%; p = 0.012) in a higher-risk subgroup (femoral neck BMD T score < −3.0). In addition, oral ibandronate was well tolerated. Oral ibandronate, whether administered daily or intermittently with an extended between-dose interval of >2 months, is highly effective in reducing the incidence of osteoporotic fractures in postmenopausal women. This is the first time that significant fracture efficacy has been prospectively shown with an intermittently administered bisphosphonate in the overall study population of a randomized, controlled clinical trial. Thus, oral ibandronate holds promise as an effective and convenient alternative to current bisphosphonate therapies.

Overview

The claims and statistics of this paper haven’t been checked yet.

Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.

A few free checks a day · papers already verified open instantly · results are public

Integrity signals

Registry

Crossref · 10.1359/jbmr.040325

Cites

42 of 42 references verified0 citation errors · 0 not checkable

Statistics

Verification

Claims the paper makes

The claims and statistics of this paper haven’t been checked yet.

Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.

A few free checks a day · papers already verified open instantly · results are public

Claims other papers make about this one

Each is checked against this paper’s own text: does it say what the citing paper says it does?

Self-check

Percentages, sums and reported differences re-computed from the paper’s own numbers.

The self-check needs the paper’s full text.

Citations

Cites

Show all 42 references

Research works printed but not linked: 4

  1. Melton, 1991, Long-term fracture risk prediction with bone mineral measurements made at various skeletal sites, J Bone Miner Res, 6, S136
  2. Kendler, 2002, Patient preference of once weekly or daily administration of alendronate (Fosamax) for osteoporosis: a randomized cross-over study, Osteoporos Int, 13, S32
  3. Palmisano, 2002, Preference study of alendronate 70 mg once weekly and alendronate 10 mg once daily in postmenopausal women with osteoporosis, Osteoporos Int, 13, S36
  4. Kiel, 1995, Assessing vertebral fractures. National Osteoporosis Foundation Working Group on Vertebral Fractures, J Bone Miner Res, 10, 518

Cited by

Sorted by citations

Items 801–900 of 999

Related

See all

Metadata

Authors
Chesnut, C. H., Skag, A., Christiansen, C., Recker, R., Stakkestad, J. A., Hoiseth, A., Felsenberg, D., Huss, H., Gilbride, J., Schimmer, R. C., Delmas, P. D., & (BONE), F. T. O. I. O. V. F. T. I. N. A. A. E.
Affiliations
  • University of Washington (US)
  • Center for Clinical Trials, Bergen, Norway
  • Center for Clinical & Basic Research (DK)
  • Creighton University (US)
  • CECOR AS, Haugesund, Norway
  • Oslo Department, Sentrum Røntgen Institut AS, Oslo, Norway
  • Universitatsklinikum Benjamin Franklin, Berlin, Germany
  • Leverkusen, Germany
  • Roche (United Kingdom) (GB)
  • F. Hoffmann-La Roche AG (CH)
  • Lyon 1 Université (FR)
Corresponding author
Chesnut, Charles H
ORCID
Venue
Journal of Bone and Mineral Research
Publisher
Oxford University Press (OUP)
Published
2004-08-01
Volume
19
Issue
8
Pages
1241-1249
ISSN
  • 0884-0431 (ISSN-L)
  • 1523-4681
DOI
10.1359/jbmr.040325
OpenAlex
W2099054178
Cited by
1,229
References
42
Citations by year
2026: 14 · 2025: 38 · 2024: 20 · 2023: 42 · 2022: 31 · 2021: 37 · 2020: 35 · 2019: 32 · 2018: 32 · 2017: 31 · 2016: 43 · 2015: 45 · 2014: 45 · 2013: 63 · 2012: 62
FWCI
85.94
Type
journal article
Language
en
Open access
Licence
academic.oup.com/journals/pages/open_access/funder_policies/chorus/standard_publication_model (vor)
Locations
  • Journal of Bone and Mineral Research (publishedVersion)
  • PubMed (publishedVersion)
Funders
F. Hoffmann-La Roche
Topics
  • Health Sciences › Medicine › Orthopedics and Sports Medicine › Bone health and osteoporosis research
  • Health Sciences › Medicine › Oncology › Bone health and treatments
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Menopause: Health Impacts and Treatments
Keywords
ibandronate, intermittent dosing, bisphosphonates, postmenopausal osteoporosis, vertebral fractures, fracture risk reduction, bone mineral density, bone turnover, height loss, drug safety, medication adherence, lumbar spine, hip bone density, antifracture efficacy, treatment discontinuation, adverse events
MeSH terms
Ibandronic Acid, Aged, Body Height, Bone and Bones, Diphosphonates, Double-Blind Method, Female, Femur, Humans, Lumbar Vertebrae, Middle Aged, Pelvic Bones, Prospective Studies, Risk Factors, Bone Density, Osteoporosis, Postmenopausal, Spinal Fractures, Treatment Outcome, Patient Selection, Fractures, Bone

About these checks

Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.

Statistics and arithmetic are recomputed, not judged.

Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.

What counts as a claim ›How we measure confidence ›How we check this ›

Are you an author, or do you see a problem with this page? Request a review