Long-term Adverse Effects After Bariatric Surgery on Bone Density
FUB-A
1 other identifier
interventional
140
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 2, 2018
CompletedFirst Posted
Study publicly available on registry
January 25, 2018
CompletedStudy Start
First participant enrolled
February 2, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 30, 2019
CompletedAugust 13, 2019
August 1, 2019
1.3 years
January 2, 2018
August 12, 2019
Conditions
Outcome Measures
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
5-7 years after bariatric surgery
Secondary Outcomes (4)
Total vertebral T-Score measured with dual-energy x-ray absorptiometry
5-7 years after bariatric surgery
fracture risk assessed by FRAX score
5-7 years after bariatric surgery
plasma concentration of C-terminal telopeptide (CTX)
5-7 years after bariatric surgery
plasma concentration of vitamin D3
5-7 years after bariatric surgery
Study Arms (2)
Gastric Bypass
ACTIVE COMPARATORPatients ≥ 5 years after laparoscopic gastric bypass receive DEXA (= Dual-energy x-ray absorptiometry) in order to measure bone mass density
Sleeve gastrectomy
ACTIVE COMPARATORPatients ≥ 5 years after laparoscopic sleeve gastrectomy receive DEXA (= Dual-energy x-ray absorptiometry) in order to measure bone mass density
Interventions
measurement of vertebral bone and hip bone mineral density
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
St Claraspital
Basel, 4016, Switzerland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bettina K Wölnerhanssen, MD
Clinical Research St. Claraspital Basel
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 2, 2018
First Posted
January 25, 2018
Study Start
February 2, 2018
Primary Completion
May 30, 2019
Study Completion
May 30, 2019
Last Updated
August 13, 2019
Record last verified: 2019-08
Data Sharing
- IPD Sharing
- Will not share