Evidence map›Paper›PMID 33595680›Full record

ArticleOsteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA2021

Fragility of results from randomized controlled trials supporting the guidelines for the treatment of osteoporosis: a retrospective analysis.

X Huang, B Chen, L Thabane, J D Adachi, G Li

Abstract read
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In one paragraph

Article in Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 2 pooled it
–field-weighted citation impact
1 · What the graph read from 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.

2 · The registry

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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Assessing the robustness of COVID-19 vaccine efficacy trials: systematic review and meta-analysis, January 2023.Euro surveillance : bulletin Europeen sur les maladies transmissibles = European communicable disease bulletin · 2023
    Pooled it
  2. Pooled it
  3. Fragility of Evidence for the Efficacy of Anti-Fracture Medications.The Journal of clinical endocrinology and metabolism · 2025
    Article
  4. Article
  5. Review
  6. Article
  7. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors.

X HuangCenter for Clinical Epidemiology and Methodology (CCEM), Guangdong Second Provincial General Hospital, Guangzhou, China.
B ChenDepartment of Endocrinology, Guangdong Second Provincial General Hospital, Guangzhou, China.
L ThabaneDepartment of Health research methods, Evidence, and Impact (HEI), McMaster University, 1280 Main St West, Hamilton, ON, L8S 4 L8, Canada.
J D AdachiDepartment of Medicine, McMaster University, Hamilton, ON, Canada.
G LiCenter for Clinical Epidemiology and Methodology (CCEM), Guangdong Second Provincial General Hospital, Guangzhou, China. lig28@mcmaster.ca.ORCID http://orcid.org/0000-0002-3472-8513

Funding

Doctoral workstation foundation of Guangdong Second Provincial general Hospital 2021BSGZ001Science and Technology Program of Guangzhou 202002030252Science Foundation of Guangdong Second Provincial General Hospital YY2018-002
6 · The paper itself

Abstract

This is the first report on the fragility of results from randomized controlled trials (RCTs) for the treatment of osteoporosis. The results of aforementioned RCTs appear to depend on a small number of events and are generally statistically fragile.

introductionOsteoporosis remains a health concern worldwide. Evidence-based guideline recommendations that are mainly based on results of clinical trials are important to clinical decision-making. The fragility index (FI) is a novel statistical metric to measure the fragility of results from an RCT. Our study aimed to analyze the fragility of the clinical trials referenced in the guidelines for the treatment of osteoporosis.

methodsTrials were included if they investigated primary osteoporosis, randomized patients to treatment or control in a 1:1 design, and reported fracture outcome as the primary endpoint. The FI and fragility quotient (FQ) were calculated for assessing the robustness of results from the eligible RCTs. An FI was defined as the minimum number of events in the intervention group that needs to change from a non-event to an event in order to render a significant result non-significant (or vice versa). The FQ was calculated by dividing the FI by the sample size of the trial.

resultsOf the 372 RCTs identified from the guidelines, 42 were eligible for analyses. Their median FI was 10 (25th-75th percentile [Q1-Q3]: 4-18), with a median FQ of 0.007 (Q1-Q3: 0.0017-0.019). Approximately one third of the RCTs had a FI of less than or equal to 5. There were 17 (40.5%) trials where the number of patients lost to follow-up was greater than the FI. The FI was significantly associated with sample size, journal impact factor, and the percent of patients lost to follow-up.

conclusionResults from some RCTs supporting guideline recommendations for the treatment of osteoporosis depend on a small number of events. The FI and FQ may provide additional, intuitive metrics to help interpret the robustness of trial results.

Indexed as

OsteoporosisHumansRandomized Controlled Trials as TopicRetrospective StudiesSample SizeFragility indexGuidelineOsteoporosisRandomized controlled trial

Identifiers

PMID33595680

What OpenQuestion holds

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Registered trials

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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.