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CompletedNCT03410459FUB-AUpdated Aug 13, 2019

Long-term Adverse Effects After Bariatric Surgery on Bone Density

An interventional study of DEXA (= Dual-energy x-ray absorptiometry) in Morbid Obesity, sponsored by University Hospital, Basel, Switzerland. Completed at 1 site in Switzerland. Per ClinicalTrials.gov, last updated 2019-08-13.

Sponsored by University Hospital, Basel, Switzerland · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
140
Allocation
Non-randomized
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Morbid Obesity

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03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts 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

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)
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Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
140 participants (actual)

Study arms

  • Active comparator
    Gastric Bypass

    Patients ≥ 5 years after laparoscopic gastric bypass receive DEXA (= Dual-energy x-ray absorptiometry) in order to measure bone mass density

    Diagnostic Test: DEXA (= Dual-energy x-ray absorptiometry)

  • Active comparator
    Sleeve gastrectomy

    Patients ≥ 5 years after laparoscopic sleeve gastrectomy receive DEXA (= Dual-energy x-ray absorptiometry) in order to measure bone mass density

    Diagnostic Test: DEXA (= Dual-energy x-ray absorptiometry)

Interventions

  • Diagnostic testDEXA (= Dual-energy x-ray absorptiometry)

    measurement of vertebral bone and hip bone mineral density

05

What researchers measure

Primary outcomes

  1. Total hip T-Score measured with dual-energy x-ray absorptiometry

    measured score will be compared to reference score for this age

    Time frame: 5-7 years after bariatric surgery

Secondary outcomes

  1. Total vertebral T-Score measured with dual-energy x-ray absorptiometry

    measured score will be compared to reference score for this age

    Time frame: 5-7 years after bariatric surgery

  2. fracture risk assessed by FRAX score

    measured score will be compared to reference score for this age

    Time frame: 5-7 years after bariatric surgery

  3. plasma concentration of C-terminal telopeptide (CTX)

    measured plasma concentration will be compared to reference for this age

    Time frame: 5-7 years after bariatric surgery

  4. plasma concentration of vitamin D3

    measured plasma concentration will be compared to reference for this age

    Time frame: 5-7 years after bariatric surgery

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Study locations

1 site
  • St Claraspital
    Basel, 4016, Switzerland
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03410459
Lead sponsor
University Hospital, Basel, Switzerland
Responsible party
Sponsor
First posted
Jan 25, 2018
Start date
Feb 2, 2018
Primary completion
May 30, 2019
Completion
May 30, 2019
Last update
Aug 13, 2019

Study contacts

Bettina K Wölnerhanssen, MD
principal investigator · Clinical Research St. Claraspital Basel

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.

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