Atypical femur fracture associated with common anti-osteoporosis drugs in FDA adverse event reporting system.

Xiao Y, Chen Y, Huang Y, Xiao Y

Scientific reports5 Jul 2023Cited by 14 (Europe PMC)

PMID37407650PMCIDPMC10322871DOI10.1038/s41598-023-37944-xPepBankPUB-37407650

Summary

Atypical femur fracture (AFF) is a rare but catastrophic adverse event first reported in the long-term use of alendronate, one of the most commonly used drugs for osteoporosis currently. However, further evidence is needed to learn more regarding other common anti-osteoporosis drugs and the risk for AFF. In this study, reports of AFF were identified from Food and Drug Administration Adverse Event Reporting System database. Disproportionality analyses were performed to examine the reporting odds ratio (ROR), information component (IC) and adjusted ROR (adj. ROR) signals for AFF for common anti-osteoporosis drugs. A total of 1692 unique AFF reports were identified. The disproportionality signals (the lower bound of 95% confidence interval > 1 for ROR and adjusted ROR, and > 0 for IC) were detected for alendronate, denosumab, pamidronate, risedronate, zoledronate, ibandronate, and teriparatide while no signal was detected for raloxifene, abaloparatide, and romosozumab. When restricted in patients with osteoporosis, the disproportionality signals were still detected for alendronate, pamidronate, risedronate, denosumab, and ibandronate. Our results suggest that alendronate has the largest risk signal, while the risks varied among different bisphosphonates. In addition, denosumab was found statistically associated with AFF in both the entire database and patients with osteoporosis.

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.

01HumanObservational studySafety outcome
In FAERS reports, abaloparatide showed no disproportionality signal for atypical femur fracture.
In plain wordsIn adverse event reports, abaloparatide was not linked to a disproportionate reporting signal for atypical femur fracture.
Peptide
Abaloparatide (Tymlos)
Outcome
No significant changeAtypical femur fracture reporting signal
Study
Homo sapiensn: not reported in source
FDA Adverse Event Reporting System clinical adverse event reports
Outcome group
Bone and joint · Musculoskeletal
Studied dose
Dose not stated
Source sentences
Summary
while no signal was detected for raloxifene, abaloparatide, and romosozumab.
1 context sentence(design, population, supporting numbers)
Summary · context
In this study, reports of AFF were identified from Food and Drug Administration Adverse Event Reporting System database.
Show in the study text Report a problemFND-3740765001

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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.

Version 2Current
22 Oct 2026, 02:25 UTC
Study results updated
Version 1
21 Oct 2026, 18:59 UTC
First added · source update from Europe PMC

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