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Long-term Adverse Effects After Bariatric Surgery on Bone Density

Long-term Adverse Effects After Laparoscopic Sleeve Gastrectomy and Roux en Y Gastric Bypass (Part A)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03410459
Acronym
FUB-A
Enrollment
140
Registered
2018-01-25
Start date
2018-02-02
Completion date
2019-05-30
Last updated
2019-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Morbid Obesity

Brief summary

The goal of this trial is to examine long-term effects of laparoscopic gastric bypass (LRYGB) and sleeve gastrectomy (LSG) on bone mineral density, fracture risk, and body composition ≥ 5 years post-surgery.

Detailed description

Bariatric surgery shows impressive results in terms of weight loss and resolution of comorbidities. Still, there are questions as to the frequency of long-term adverse effects: data on alterations in bone health are missing, The goal of this trial is to examine long-term effects of laparoscopic gastric bypass (LRYGB) and sleeve gastrectomy (LSG) on bone mineral density, fracture risk, and body composition ≥ 5 years post-surgery.

Interventions

DIAGNOSTIC_TESTDEXA (= Dual-energy x-ray absorptiometry)

measurement of vertebral bone and hip bone mineral density

Sponsors

University Hospital, Basel, Switzerland
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* Patients who received laparoscopic sleeve gastrectomy (LSG) or laparoscopic gastric bypass (LRYGB) ≥ 5 years ago as a primary bariatric procedure will be eligible for this study.

Exclusion criteria

* LSG or LRYGB as a secondary bariatric procedure (e.g. after gastric banding), patients receiving secondary bariatric operation after LSG resp LRYGB (e.g. biliopancreatic diversion), pregnancy (due to radiation exposition)

Design outcomes

Primary

MeasureTime frameDescription
Total hip T-Score measured with dual-energy x-ray absorptiometry5-7 years after bariatric surgerymeasured score will be compared to reference score for this age

Secondary

MeasureTime frameDescription
Total vertebral T-Score measured with dual-energy x-ray absorptiometry5-7 years after bariatric surgerymeasured score will be compared to reference score for this age
fracture risk assessed by FRAX score5-7 years after bariatric surgerymeasured score will be compared to reference score for this age
plasma concentration of C-terminal telopeptide (CTX)5-7 years after bariatric surgerymeasured plasma concentration will be compared to reference for this age
plasma concentration of vitamin D35-7 years after bariatric surgerymeasured plasma concentration will be compared to reference for this age

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026