Healthy Body, Healthy Bones After Bariatric Surgery Trial

Bariatric Surgery Candidate Clinical Trial

Official title:

Feasibility of Bisphosphonate Use on Sleeve Gastrectomy Associated Bone Loss: Healthy Body, Healthy Bones Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04279392
• Other study ID #: 0820-19-FB
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: September 1, 2020
• Est. completion date: December 30, 2022

Study information

• Verified date: October 2023
• Source: University of Nebraska
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 30, 2022
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Bariatric Surgery Candidate
• Bone Loss
• Bone Resorption

Intervention

Drug:
• Zoledronic Acid 5 mg/Bag 100 ml Inj
Zoledronic acid infusion
• Placebos
Saline infusion

Locations

Country	Name	City	State
United States	Bariatric Center, Nebraska Medicine	Omaha	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
University of Nebraska

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Feasibility: Proportion of participants completing 9 Month study visit requirements	Proportion of participants completing 9 Month study visit requirements	9 Months
Other	Tolerance: total number of adverse events reported by participants in the active and in-active arms	Comparison of the total number of adverse events reported by participants in the active and in-active arms	9 Months
Primary	Change in Hip Bone Mineral Density (BMD) by DXA	g/cm2	9 months
Secondary	Change in Lumbar spine bone mineral density (BMD) by DXA	g/cm2 of L1-L4	9 months
Secondary	Change in Finite Element Analysis of lumbar spine (L2)	Strength in Newtons	9 Months
Secondary	Change in NTx bone resorption marker	nM and percent change	9 Months
Secondary	Change in P1NP bone formation marker	pg/mL and percent change	9 Months
Secondary	Change in Lean Mass	kg and % body weight as measured by DXA	9 Months
Secondary	Change in Fat Mass	kg and % body weight as measured by DXA	9 Months
Secondary	Change in Chair-Stands test performance	Change in time to sit-stand five times from a chair (seconds)	9 Months
Secondary	Change in handgrip strength	Newtons	9 Months
Secondary	Change in Gait-speed	Time to walk 20 meters (seconds)	9 Months
Secondary	Change in volumetric BMD of the hip by CT scan	g/cm3	9 months
Secondary	Change in volumetric BMD of the spine (L1-L4) by CT scan	g/cm3	9 months
Secondary	Change in Weight	pounds	9 months