SynthesisThe Journal of bone and joint surgery. American volume2013
Bisphosphonates and nonhealing femoral fractures: analysis of the FDA Adverse Event Reporting System (FAERS) and international safety efforts: a systematic review from the Research on Adverse Drug Events And Reports (RADAR) project.
Synthesis in The Journal of bone and joint surgery. American volume, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03401060 (Interest of Denosumab Treatment in Osteoporosis Associated to Systemic Mastocytosis), which is not on this map. Cited by 56 papers, 6 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Interest of Denosumab Treatment in Osteoporosis Associated to Systemic Mastocytosis
Who cites it
56 citing papers in PubMed, 6 syntheses or guidelines pooled it.
- Efficacy of Chinese herbal medicine in patients with osteoporosis: a systematic review and meta-analysis.Frontiers in medicine · 2025Pooled it
- Etidronate for the primary and secondary prevention of osteoporotic fractures in postmenopausal women.The Cochrane database of systematic reviews · 2024Pooled it
- Early bisphosphonate therapy post proximal femoral fracture fixation does not impact fracture healing: a systematic review and meta-analysis.ANZ journal of surgery · 2022Pooled it
- Risedronate for the primary and secondary prevention of osteoporotic fractures in postmenopausal women.The Cochrane database of systematic reviews · 2022Pooled it
- Qianggu capsule for the treatment of primary osteoporosis: evidence from a Chinese patent medicine.BMC complementary and alternative medicine · 2017Pooled it
- Ulnar fractures with bisphosphonate therapy: a systematic review of published case reports.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2015Pooled it
- Cost-Effectiveness Analysis of Monthly Zoledronic Acid, Zoledronic Acid Every 3 Months, and Monthly Denosumab in Women With Breast Cancer and Skeletal Metastases: CALGB 70604 (Alliance).Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2017Trial
- The dinitrothiophenol SN-2 reduces osteoclastogenesis and estrogen deficiency-induced bone loss by inhibiting TRAF6 auto-ubiquitination.Bone reports · 2026Article
- Tirzepatide safety in type 2 diabetes: a disproportionality analysis of adverse events using the FDA FAERS database.Endocrine connections · 2025Article
- Effect of recombinant human parathyroid hormone and zoledronic acid on osteoblast gene expression using multifaceted approach: An in vitro study.Indian journal of pharmacology · 2025Article
- Osteoporosis and Rheumatoid Arthritis: Mechanisms Underlying Osteoclast Differentiation and Activation or Factors Associated with Hip Fractures.Journal of clinical medicine · 2025Review
- Age-stratified analysis of adverse event signals for clarithromycin: a disproportionality analysis using the FDA Adverse Event Reporting System.Therapeutic advances in drug safety · 2025Article
- Efficacy and safety of bisphosphonates in pediatric glucocorticoid-induced osteoporosis: a meta-analysis and pharmacovigilance study.Frontiers in pediatrics · 2025Article
- Age-stratified pharmacovigilance of azithromycin: a multimethod signal detection analysis in the FAERS database.Journal of pharmaceutical policy and practice · 2025Article
- Article
- Atypical femur fracture in a male without history of bisphosphonate use: a case report.Journal of medical case reports · 2024Article
- Impact of osteopenia and osteosarcopenia on the outcomes after surgery of hepatobiliary-pancreatic cancers.Frontiers in oncology · 2024Article
- Article
- Cardiovascular Safety Evaluation of Febuxostat and Allopurinol: Findings from the FDA Adverse Event Reporting System.Journal of clinical medicine · 2023Article
- Post-Fracture Care Program: Pharmacological Treatment of Osteoporosis in Older Adults with Fragility Fractures.Current osteoporosis reports · 2023Review
Corrections and comments
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Authors and funding
16 authors.
Funding
Abstract
backgroundIn the United States, hip fracture rates have declined by 30% coincident with bisphosphonate use. However, bisphosphonates are associated with sporadic cases of atypical femoral fracture. Atypical femoral fractures are usually atraumatic, may be bilateral, are occasionally preceded by prodromal thigh pain, and may have delayed fracture-healing. This study assessed the occurrence of bisphosphonate-associated nonhealing femoral fractures through a review of data from the U.S. FDA (Food and Drug Administration) Adverse Event Reporting System (FAERS) (1996 to 2011), published case reports, and international safety efforts.
methodsWe analyzed the FAERS database with use of the proportional reporting ratio (PRR) and empiric Bayesian geometric mean (EBGM) techniques to assess whether a safety signal existed. Additionally, we conducted a systematic literature review (1990 to February 2012).
resultsThe analysis of the FAERS database indicated a PRR of 4.51 (95% confidence interval [CI], 3.44 to 5.92) for bisphosphonate use and nonhealing femoral fractures. Most cases (n = 317) were attributed to use of alendronate (PRR = 3.32; 95% CI, 2.71 to 4.17). In 2008, international safety agencies issued warnings and required label changes. In 2010, the FDA issued a safety notification, and the American Society for Bone and Mineral Research (ASBMR) issued recommendations about bisphosphonate-associated atypical femoral fractures.
conclusionsNonhealing femoral fractures are unusual adverse drug reactions associated with bisphosphonate use, as up to 26% of published cases of atypical femoral fractures exhibited delayed healing or nonhealing.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.