Healthy Body, Healthy Bones After Bariatric Surgery Trial

Phase 1

Completed

Conditions: Bariatric Surgery Candidate
Bone Loss
Bone Resorption

Interventions: Drug: Zoledronic Acid 5 mg/Bag 100 ml Inj
Drug: Placebos

Registration Number: NCT04279392

Lead Sponsor: University of Nebraska

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 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.

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 weight loss associated with bariatric surgery adversely affects bone metabolism. Significant decreases in bone mineral density lead to an increased risk of fracture and subsequent reduction in physical function among bariatric surgery patients. Bisphosphonate medications, such as zoledronic acid, have been evaluated for safety and efficacy in combating bone loss in patients with osteoporosis, but their use in bariatric surgery-induced bone loss has not been explored. The primary goal of this study is to investigate whether bisphosphonate therapies are able to combat bone loss associated with surgical weight loss procedures. This research proposal is a 1-year, pilot randomized controlled trial (RCT) involving 30 adult sleeve gastrectomy patients randomized to receive either a one-time zoledronic acid infusion or placebo (n=15 per group). The investigators hypothesize that zoledronic acid, a standard treatment for low bone density, will be an effective intervention to reduce sleeve gastrectomy-induced bone loss. Bone loss is an unintended consequence of an otherwise life-saving procedure, with declining bone health potentially contributing to major morbidity in those undergoing a bariatric procedure. Identifying effective interventions to minimize bone loss is crucial for comprehensive treatment of patients who undergo bariatric surgery. Specific Aim 1: To determine the efficacy of zoledronic acid in preventing bone loss associated with sleeve gastrectomy (SG). Bone mineral density (BMD) and bone turnover markers will be measured at baseline and 9 months. The primary outcome is change in BMD as measured by Dual-energy x-ray absorptiometry (DXA). Secondary outcomes are change in BMD as measured by Quantitative Computed Tomography (QCT) and change in the serum bone turnover markers, urinary collagen type 1 cross-linked N-telopeptide (CTX; bone formation marker), serum type 1 procollagen N-terminal (P1NP; bone resorption marker), sclerostin, and osteocalcin. Specific Aim 2: To evaluate the feasibility of this trial in those who have undergone SG surgery. The feasibility will be assessed by documenting adverse events and compliance rates of the intervention at each study time point.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 10

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)

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active Infusion	Zoledronic Acid 5 mg/Bag 100 ml Inj	At 6 weeks post surgery, 5 mg of zoledronic acid in 100 ml of saline will be infused intravenously over a 15 minute time period.
Non-active Infusion	Placebos	At 6 weeks post surgery, 100 ml of saline will be infused intravenously over a 15 minute time period.

Primary Outcome Measures

Name	Time	Method
Change in Hip Bone Mineral Density (BMD)	baseline and 10 months post-surgery	Change in hip bone mineral density (BMD) measured by dual-energy x-ray absorptiometry (DXA) - g/cm2

Secondary Outcome Measures

Name	Time	Method
Change in Lumbar Spine Bone Mineral Density (BMD)	baseline and 10 months post-surgery	Change in lumbar spine bone mineral density (BMD) measured by dual-energy x-ray absorptiometry (DXA)/cm2 of L1-L4 lumbar vertebrae
Change in Trunk Lean Mass	baseline and 9 months post-surgery	Change in trunk lean mass, measured in kg
Change in Trunk Fat Mass	baseline and 9 months post-surgery	Change in Trunk fat mass, measured in kg
Change in Weight	baseline and 9 months post-surgery	Change in weight, measured in kgs