Effects of Oral Ibandronate Administered Daily or Intermittently on Fracture Risk in Postmenopausal Osteoporosis
Open accessAbstract
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.
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Reduction in risk of nonvertebral fracture with ibandronate has not been documented.
“Ibandronate reduces the incidence of vertebral fractures by about 50 % over 3 years, but reduction in risk of nonvertebral fracture with ibandronate has not been documented [50].”
From Clinician’s Guide to Prevention and Treatment of Osteoporosis (2014) · cites this paper as [50]
The Clinical osteoporotic nonvertebral fractures section reports a statistically significant 69% reduction with daily ibandronate in women with a baseline femoral-neck BMD T score below −3.0. The Discussion cautions that this was a post hoc analysis and says there was no significant reduction in the overall population, but the unqualified claim that a reduction has not been documented overlooks the reported subgroup finding. Page numbers were not provided in the supplied passages. (LLM, conf=0.88)
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Experimental — accuracy not yet measuredThe reduced fracture risk with pharmacologic therapy in patients with spine and hip fractures is true for fracture patients with BMD in both the low bone mass and osteoporosis range.
“This is true for fracture patients with BMD in both the low bone mass and osteoporosis range [49–58].”
From Clinician’s Guide to Prevention and Treatment of Osteoporosis (2014) · cites this paper as [50]
The Participants and Efficacy sections (pages unavailable) show that the trial enrolled women with prior vertebral fractures and found fewer new vertebral fractures with ibandronate than with placebo. Statistical methods notes that some participants had lumbar-spine BMD in the low-bone-mass range, but the reported overall reduction does not establish a reduction in both BMD ranges separately. The paper did not study patients selected for prior hip fracture, and it found no significant reduction in nonvertebral fractures in the overall population. (LLM, conf=0.86)
Experimental — accuracy not yet measuredThere are abundant data that patients with spine and hip fractures will have reduced fracture risk if treated with pharmacologic therapy.
“There are abundant data that patients with spine and hip fractures will have reduced fracture risk if treated with pharmacologic therapy.”
From Clinician’s Guide to Prevention and Treatment of Osteoporosis (2014) · cites this paper as [50]
The Participants and Efficacy sections report that postmenopausal women with prior vertebral fractures had fewer new vertebral fractures when treated with ibandronate than with placebo. The study does not establish the same benefit for patients with prior hip fractures or for pharmacologic therapies generally; the Discussion also reports no statistically significant reduction in nonvertebral fractures in the overall study population. Page numbers are unavailable in our copy. (LLM, conf=0.88)
Experimental — accuracy not yet measuredIbandronate reduces the incidence of vertebral fractures by about 50% over 3 years.
“Ibandronate reduces the incidence of vertebral fractures by about 50 % over 3 years, but reduction in risk of nonvertebral fracture with ibandronate has not been documented [50].”
From Clinician’s Guide to Prevention and Treatment of Osteoporosis (2014) · cites this paper as [50]
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- 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
- 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
- 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
- bronze
- doi.org
- 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
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