Healthy Body, Healthy Bones After Bariatric Surgery Trial

• Status: Recruiting
• Trial end date: 2023-06-30
• Target enrollment: 0
• Participant gender: All

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 weight loss associated with bariatric surgery adversely affects bone leads to an increased risk of fracture. Bisphosphonate medications, such as zoledronic acid, are used to treat bone loss in patients with osteoporosis, and this study investigates whether this medication can prevent bone loss associated with surgical weight loss procedures.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Nebraska
• Treatments: Zoledronic Acid

Criteria

Inclusion Criteria:

• Subjects planning a sleeve gastrectomy procedure at the 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 Criteria:

• 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)