Cited by 544Diabetes Treatment and ManagementBone health and osteoporosis researchDiabetes, Cardiovascular Risks, and Lipoproteins

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Rosiglitazone-Associated Fractures in Type 2 Diabetes

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Kahn, Steven E., Zinman, Bernard, Lachin, John M., Haffner, Steven M., Herman, William H., Holman, Rury R., Kravitz, Barbara G., Yu, Dahong, Heise, Mark A., Aftring, R. Paul, Viberti, Giancarlo, for the A Diabetes Outcome Progression Trial (ADOPT) Study Group·2008·Diabetes Care

DOI 10.2337/dc07-2270

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Abstract

OBJECTIVE—The purpose of this study was to examine possible factors associated with the increased risk of fractures observed with rosiglitazone in A Diabetes Outcome Progression Trial (ADOPT). RESEARCH DESIGN AND METHODS—Data from the 1,840 women and 2,511 men randomly assigned in ADOPT to rosiglitazone, metformin, or glyburide for a median of 4.0 years were examined with respect to time to first fracture, rates of occurrence, and sites of fractures. RESULTS—In men, fracture rates did not differ between treatment groups. In women, at least one fracture was reported with rosiglitazone in 60 patients (9.3% of patients, 2.74 per 100 patient-years), metformin in 30 patients (5.1%, 1.54 per 100 patient-years), and glyburide in 21 patients (3.5%, 1.29 per 100 patient-years). The cumulative incidence (95% CI) of fractures in women at 5 years was 15.1% (11.2–19.1) with rosiglitazone, 7.3% (4.4–10.1) with metformin, and 7.7% (3.7–11.7) with glyburide, representing hazard ratios (95% CI) of 1.81 (1.17–2.80) and 2.13 (1.30–3.51) for rosiglitazone compared with metformin and glyburide, respectively. The increase in fractures with rosiglitazone occurred in pre- and postmenopausal women, and fractures were seen predominantly in the lower and upper limbs. No particular risk factor underlying the increased fractures in female patients who received rosiglitazone therapy was identified. CONCLUSIONS—Further investigation into the risk factors and underlying pathophysiology for the increased fracture rate in women taking rosiglitazone is required to relate them to preclinical data and better understand the clinical implications of and possible interventions for these findings.

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Authors: Kahn, S. E., Zinman, B., Lachin, J. M., Haffner, S. M., Herman, W. H., Holman, R. R., Kravitz, B. G., Yu, D., Heise, M. A., Aftring, R. P., Viberti, G., & for the A Diabetes Outcome Progression Trial (ADOPT) Study Group
Affiliations: University of Washington (US)
Mount Sinai Hospital (CA)
George Washington University (US)
The University of Texas at San Antonio Health Science Center (US)
University of Michigan (US)
Oxford Centre for Diabetes, Endocrinology and Metabolism (GB)
GlaxoSmithKline (United States) (US)
King's College London (GB)
ORCID: Kahn, Steven E.
Zinman, Bernard
Lachin, John M.
Herman, William H.
Holman, Rury R.
Yu, Dahong
Heise, Mark A.
Venue: Diabetes Care
Publisher: American Diabetes Association
Published: 2008-05-01
Volume: 31
Issue: 5
Pages: 845-851
ISSN: 0149-5992 (ISSN-L)
1935-5548
DOI: 10.2337/dc07-2270
OpenAlex: W2099673402
Cited by: 537
References: 22
Citations by year: 2026: 7 · 2025: 10 · 2024: 10 · 2023: 11 · 2022: 17 · 2021: 30 · 2020: 18 · 2019: 19 · 2018: 36 · 2017: 31 · 2016: 31 · 2015: 31 · 2014: 40 · 2013: 43 · 2012: 41
FWCI: 39.37
Type: journal article
Language: en
Open access: bronze
doi.org
Locations: Diabetes Care (publishedVersion)
PubMed (publishedVersion)
Funders: GlaxoSmithKline
Topics: Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
Health Sciences › Medicine › Orthopedics and Sports Medicine › Bone health and osteoporosis research
Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes, Cardiovascular Risks, and Lipoproteins
Keywords: rosiglitazone, fracture, type 2 diabetes, ADOPT trial, metformin, glibenclamide, sex differences, women, fracture risk factors, bone fragility, thiazolidinediones
MeSH terms: Rosiglitazone, Aged, Diabetes Mellitus, Type 2, Female, Glyburide, Humans, Hypoglycemic Agents, Male, Metformin, Middle Aged, Treatment Outcome, Age of Onset, Disease Progression, Thiazolidinediones, Fractures, Bone

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Rosiglitazone-Associated Fractures in Type 2 Diabetes

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