Randomised controlled trialcited by the Tayebat archiveabstract only checked A-ODD-13 standard review

Canagliflozin and fractures

Effects of Canagliflozin on Fracture Risk in Patients With Type 2 Diabetes Mellitus.

Overview

Watts NB et al.. J Clin Endocrinol Metab 2016 · PMID 26580237 · DOI 10.1210/jc.2015-3167

More fractures in one trial with older high-risk patients, not in others.

Does the study support the specific claim? Partly · Methodological quality: moderate

Study explained simply

What did the researchers want to find out?: Canagliflozin and fracture risk
How was the study done?: Pooled analysis of 9 phase 3 RCTs incl. CANVAS
How many people, animals or samples were studied?: 10,194; Type 2 diabetes
What was actually found?: 4.0 vs 2.6% in CANVAS.
How large was the observed effect?: +1.4 pp in CANVAS
What do the results mean in everyday life?: Fall prevention in frail patients.
What are the study's limitations?: Pooled post-hoc
What does it say about Elawady's specific claim?: Supports C-ODD-05 (signal).
Do the results apply to Germany and Europe?: Multinational/US/UK data; transferable to EU practice.
What can explicitly not be concluded from this study?: Class effect.

Authors: Watts NB, Bilezikian JP, Usiskin K, Edwards R, Desai M, Law G, Meininger G
Journal: J Clin Endocrinol Metab
Year: 2016
Identifier: PMID 26580237 DOI 10.1210/jc.2015-3167 · PMC4701850
Verification: verified – PubMed E-utilities efetch, 2026-10-25
Retracted: no
Corrections: none
Extent checked: abstract only
Conflicts of interest and funding: Janssen-sponsored (grant listed NCI).

Canagliflozin and fracture risk

Study design: Randomised controlled trial – Pooled analysis of 9 phase 3 RCTs incl. CANVAS
Population: Type 2 diabetes
Country: International
Period: Trial periods
Sample size: 10,194
Inclusion and exclusion criteria: As described in the abstract; details not available in abstract.

Results: Non-CANVAS 1.7% vs 1.5%; CANVAS 4.0% vs 2.6% (significant); overall 2.7% vs 1.9%.
Absolute risks: not reported
Authors' conclusion: Fracture risk increased, driven by CANVAS (older, CVD, lower eGFR, diuretics); possibly mediated by falls; cause unknown.

Signal confined to one trial.

Supports C-ODD-05 (signal).

Multinational/US/UK data; transferable to EU practice.

Inconsistent signal.

Multidimensional assessment
Multidimensional assessment
Authenticity of the source	verified
Methodological quality	moderate
Risk of bias	some concerns
Precision of results	moderate
Directness	direct
Reproducibility	not replicated
Consistency with the overall evidence	inconsistent
Regional transferability	high
Adequacy of the interpretation (by the archive)	not applicable

None beyond those stated.

Note: according to the archive, the studies were compiled by the archive operators. Whether Dr. Elawady himself cited this study is not established.

What the archive says about the study: Listed in the archive bibliography for 'oral-diabetes-drugs' without its own interpretation; used as support for the claim that every drug class carries documented harm.
A. What was actually studied?: Canagliflozin and fracture risk
B. What did the authors find?: 4.0 vs 2.6% in CANVAS.
C. What conclusions do the authors themselves draw?: Fracture risk increased, driven by CANVAS (older, CVD, lower eGFR, diuretics); possibly mediated by falls; cause unknown.
D. What does the archive derive from it?: Support for SGLT2 harm.
E. Is this derivation scientifically justified?: Partly; CREDENCE found no fracture difference (I-ODD-05).
Adequacy of the interpretation (by the archive): not applicable