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Study · Randomized controlled trial · n = 14,752 · 2025

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Risk factors for bone fractures in type 2 diabetes and the impact of once-weekly exenatide: insights from an EXSCEL post-hoc analysis.

Maddaloni E, Coleman RL, Holman RR

Diabetes research and clinical practice26 Mar 2025Cited by 6 (Europe PMC)

PMID40154887 (opens in a new tab)DOI10.1016/j.diabres.2025.112125 (opens in a new tab)PepBankPUB-40154887
Publisher pagePubMedAsk about this study
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Summary

AimsWe investigated bone fracture predictors in people with T2D enrolled in the EXenatide Study of Cardiovascular Event Lowering (EXSCEL) and evaluated the effects of once-weekly exenatide (EQW) on incident bone fractures.MethodsEXSCEL randomised 14,752 people to EQW 2 mg or placebo with a median follow-up of 3.2 years. In this post-hoc analysis, baseline features associated with incident bone fractures were evaluated with multivariable Cox proportional hazard regression models, accounting for age and sex as confounders. Incidence rates were compared between study arms, and time-to-event analyses performed using Cox-proportional hazard models.ResultsThe primary outcome occurred in 168 (1.1 %) participants. The presence of neuropathy at baseline was associated with a 50 % higher risk (hazard ratio [HR] 1.50, 95 % confidence interval [CI] 1.10-2.05, P = 0.010) of incident bone fractures, while taking metformin at baseline was associated with a 47 % lower risk (HR 0.53, 95 %CI 0.39-0.73, P < 0.001). Incidence rates of bone fractures were similar in the EQW group and in the placebo group (HR 1.11, 95 %CI 0.82-1.51, P = 0.49).ConclusionsBone fractures in people with T2D occur more frequently in those with diabetic neuropathy, but less frequently in those taking metformin. No evidence was seen of any impact of EQW treatment on bone fractures.
CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study1

1 result from studies that gave the peptide. 1 result from people.

  1. 01HumanRandomized controlled trialSafety outcome

    In people with T2D, bone fracture incidence was similar with once-weekly exenatide and placebo.

    In plain wordsIn people with T2D, bone fractures occurred at similar rates with once-weekly exenatide and placebo.

    Peptide
    Exenatide (exendin-4)
    Outcome
    No significant changeIncident bone fractures
    Study

    n = 14,752

    Comparator
    Placebo
    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    2 mg once weekly · median follow-up 3.2 yearsAs given in this study (human).

    Measurements

    Fracture hazard ratio
    1.11 ratio
    exenatide versus placebo
    95% CI lower
    0.82 ratio
    exenatide versus placebo
    95% CI upper
    1.51 ratio
    exenatide versus placebo

    Source sentences

    Summary
    Incidence rates of bone fractures were similar in the EQW group and in the placebo group (HR 1.11, 95 %CI 0.82-1.51, P = 0.49).
    2 context sentences
    Summary · context
    EXSCEL randomised 14,752 people to EQW 2 mg or placebo with a median follow-up of 3.2 years.
    Summary · context
    In this post-hoc analysis, baseline features associated with incident bone fractures were evaluated with multivariable Cox proportional hazard regression models, accounting for age and sex as confounders.

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Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

  1. Version 2Current

    22 Oct 2026, 02:26 UTC

    Study results updated

  2. Version 1

    21 Oct 2026, 18:59 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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