Status:
COMPLETED
Healthy Body, Healthy Bones After Bariatric Surgery Trial
Lead Sponsor:
University of Nebraska
Conditions:
Bariatric Surgery Candidate
Bone Loss
Eligibility:
All Genders
19+ years
Phase:
PHASE1
PHASE2
Brief Summary
One in three adults in the United States suffers from obesity. Bariatric surgery is an increasingly utilized and effective treatment for obesity and obesity-related comorbidities, however, the massive...
Detailed Description
One in three adults in the United States suffers from obesity. Bariatric surgery is an increasingly utilized and effective treatment for obesity and obesity-related comorbidities, however, the massive...
Eligibility Criteria
Inclusion
- Subjects planning a sleeve gastrectomy procedure at the University of Nebraska Medical Center (UNMC) Bariatric Center
- Agreement to all study procedures and assessments
- Women must be postmenopausal (FSH blood level \> 30 mIU/m), or incapable of child-bearing
Exclusion
- Prior bariatric surgery
- \< 19 years of age
- Weight ≥ 350lbs
- Liver or renal disease
- Hypercalcemia, hypocalcemia, or hypomagnesemia
- Serum 25-OH vitamin D \< 20 ng/mL
- History of bone-modifying disorders
- Use of bone-active medications
- Known sensitivity to bisphosphonates
- Extensive dental work involving extraction or dental implant within the past 2 months or planned in the upcoming 6 months
- Current diagnosis of type 1 diabetes
- Current malignancy
- Autoimmune disease impacting bone (ex: Rheumatoid Arthritis)
Key Trial Info
Start Date :
September 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2022
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04279392
Start Date
September 1 2020
End Date
December 30 2022
Last Update
September 24 2024
Active Locations (1)
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1
Bariatric Center, Nebraska Medicine
Omaha, Nebraska, United States, 68198