Randomised controlled trialindependent cross-checkabstract checked I-BAR-126 standard review

Trial: bone after bypass vs sleeve

Bone Mineral Density and Turnover After Sleeve Gastrectomy and Gastric Bypass: A Randomized Controlled Trial (Oseberg).

Overview

Hofsø et al.. J Clin Endocrinol Metab 2021 · PMID 33150385 · DOI 10.1210/clinem/dgaa808

Hip and spine bone density fell more after bypass than after sleeve.

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

Original publication

Plain-language summary

Study explained simply
What did the researchers want to find out?

Bone effects RYGB vs SG

How was the study done?

RCT

How many people, animals or samples were studied?

92

What was actually found?

More bone loss after bypass

How large was the observed effect?

Spine -4.2% difference

What do the results mean in everyday life?

Bypass is harder on bone

What are the study's limitations?

Small, short

What does it say about Elawady's specific claim?

Refines the claim

Do the results apply to Germany and Europe?

Directly European

What can explicitly not be concluded from this study?

Fracture risk

Scientific in-depth review

1. Full reference

Authors
Hofsø et al.
Journal
J Clin Endocrinol Metab
Year
2021
Identifier
PMID 33150385 DOI 10.1210/clinem/dgaa808
Verification
verified – PubMed efetch 2026-10-26 + Crossref API
Retracted
no
Corrections
none
Extent checked
abstract only
Conflicts of interest and funding

not stated in abstract

2. Research question

Do sleeve gastrectomy and gastric bypass differ in BMD and bone turnover at 1 year?

3. Study design and population

Study design
Randomised controlled trial – Randomised controlled trial (Oseberg), bone secondary outcomes at 1 year
Population

Patients with severe obesity and type 2 diabetes

Country

Norway

Period

1-year follow-up

Sample size

92 analysed (44 RYGB, 48 SG)

Inclusion and exclusion criteria

Oseberg trial participants

4. Methods and endpoints

Exposure / intervention

RYGB

Comparator

SG

Endpoints

aBMD (femoral neck, hip, spine, total body); P1NP, CTX-1

Statistical methods

Between-group differences

5. Actual results

Results

Femoral neck, total hip and lumbar spine aBMD decreased more after RYGB than SG: differences -2.8% (-4.7 to -0.8), -3.0% (-5.0 to -0.9), -4.2% (-6.4 to -2.1); total body -0.5% (NS). P1NP and CTX-1 increases ~100% higher after RYGB. Effects linked to procedure, not weight change.

Absolute risks

not applicable

Authors' conclusion

RYGB was associated with greater BMD reduction and bone turnover increase than SG, suggesting greater skeletal fragility after RYGB.

6. Strengths

  • Randomised
  • Blinded

7. Weaknesses

  • Small; 1-year only
  • Secondary outcome

8. Risk of bias

Orienting tool
RoB 2
Type of assessment
simplified assessment (abstract only)
Full formal assessment
no
Overall risk of bias
low
Rationale

Randomised, triple-blind.

9. Assessment of the statistical interpretation

Between-group differences with CIs.

10. Relevance to the specific claim

Randomised evidence that bone loss is larger after bypass than sleeve.

11. Independent contrary findings

Within-group sleeve change not in abstract.

12. Transferability to Germany and Europe

Norwegian.

13. Overall methodological judgement

Supports procedure-dependence of bone loss.

Multidimensional assessment
Multidimensional assessment
Authenticity of the sourceverified
Methodological qualityhigh
Risk of biaslow
Precision of resultslow
Directnessdirect
Reproducibilitypartly replicated
Consistency with the overall evidenceconsistent
Regional transferabilityhigh
Adequacy of the interpretation (by the archive)not applicable

14. Open questions

Fractures.

15. Linked fact checks