Healthy Body, Healthy Bones After Bariatric Surgery Trial

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Bariatric Surgery Candidate, Bone Loss, Bone Resorption

In brief

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.

Key facts

Study ID

NCT04279392

Run by

University of Nebraska

People needed

10

Starts

2020-09-01

Expected to finish

2022-12-30

Last updated by the study team

2024-09-24

Who can join

Age: 19 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Bariatric Center, Nebraska Medicine — Omaha, Nebraska, United States

Full record on ClinicalTrials.gov

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