Back to resultsLong-term Adverse Effects After Bariatric Surgery on Bone Density (FUB-A)
Primary Purpose
Morbid Obesity
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
DEXA (= Dual-energy x-ray absorptiometry)
Sponsored by
About this trial
This is an interventional diagnostic trial for Morbid Obesity
Eligibility Criteria
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)
Sites / Locations
- St Claraspital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Gastric Bypass
Sleeve gastrectomy
Arm Description
Patients ≥ 5 years after laparoscopic gastric bypass receive DEXA (= Dual-energy x-ray absorptiometry) in order to measure bone mass density
Patients ≥ 5 years after laparoscopic sleeve gastrectomy receive DEXA (= Dual-energy x-ray absorptiometry) in order to measure bone mass density
Outcomes
Primary Outcome Measures
Total hip T-Score measured with dual-energy x-ray absorptiometry
measured score will be compared to reference score for this age
Secondary Outcome Measures
Total vertebral T-Score measured with dual-energy x-ray absorptiometry
measured score will be compared to reference score for this age
fracture risk assessed by FRAX score
measured score will be compared to reference score for this age
plasma concentration of C-terminal telopeptide (CTX)
measured plasma concentration will be compared to reference for this age
plasma concentration of vitamin D3
measured plasma concentration will be compared to reference for this age
Full Information
NCT ID
NCT03410459
First Posted
January 2, 2018
Last Updated
August 12, 2019
Sponsor
University Hospital, Basel, Switzerland
1. Study Identification
Unique Protocol Identification Number
NCT03410459
Brief Title
Long-term Adverse Effects After Bariatric Surgery on Bone Density
Acronym
FUB-A
Official Title
Long-term Adverse Effects After Laparoscopic Sleeve Gastrectomy and Roux en Y Gastric Bypass (Part A)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
February 2, 2018 (Actual)
Primary Completion Date
May 30, 2019 (Actual)
Study Completion Date
May 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Basel, Switzerland
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Morbid Obesity
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
140 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Gastric Bypass
Arm Type
Active Comparator
Arm Description
Patients ≥ 5 years after laparoscopic gastric bypass receive DEXA (= Dual-energy x-ray absorptiometry) in order to measure bone mass density
Arm Title
Sleeve gastrectomy
Arm Type
Active Comparator
Arm Description
Patients ≥ 5 years after laparoscopic sleeve gastrectomy receive DEXA (= Dual-energy x-ray absorptiometry) in order to measure bone mass density
Intervention Type
Diagnostic Test
Intervention Name(s)
DEXA (= Dual-energy x-ray absorptiometry)
Intervention Description
measurement of vertebral bone and hip bone mineral density
Primary Outcome Measure Information:
Title
Total hip T-Score measured with dual-energy x-ray absorptiometry
Description
measured score will be compared to reference score for this age
Time Frame
5-7 years after bariatric surgery
Secondary Outcome Measure Information:
Title
Total vertebral T-Score measured with dual-energy x-ray absorptiometry
Description
measured score will be compared to reference score for this age
Time Frame
5-7 years after bariatric surgery
Title
fracture risk assessed by FRAX score
Description
measured score will be compared to reference score for this age
Time Frame
5-7 years after bariatric surgery
Title
plasma concentration of C-terminal telopeptide (CTX)
Description
measured plasma concentration will be compared to reference for this age
Time Frame
5-7 years after bariatric surgery
Title
plasma concentration of vitamin D3
Description
measured plasma concentration will be compared to reference for this age
Time Frame
5-7 years after bariatric surgery
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bettina K Wölnerhanssen, MD
Organizational Affiliation
Clinical Research St. Claraspital Basel
Official's Role
Principal Investigator
Facility Information:
Facility Name
St Claraspital
City
Basel
ZIP/Postal Code
4016
Country
Switzerland
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Long-term Adverse Effects After Bariatric Surgery on Bone Density
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