- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04279392
Healthy Body, Healthy Bones After Bariatric Surgery Trial
October 27, 2023 updated by: University of Nebraska
Feasibility of Bisphosphonate Use on Sleeve Gastrectomy Associated Bone Loss: Healthy Body, Healthy Bones Trial
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
10
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Nebraska
-
Omaha, Nebraska, United States, 68198
- Bariatric Center, Nebraska Medicine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Active Infusion
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.
|
Zoledronic acid infusion
Other Names:
|
Placebo Comparator: Non-active Infusion
At 6 weeks post surgery, 100 ml of saline will be infused intravenously over a 15 minute time period.
|
Saline infusion
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Hip Bone Mineral Density (BMD) by DXA
Time Frame: 9 months
|
g/cm2
|
9 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Lumbar spine bone mineral density (BMD) by DXA
Time Frame: 9 months
|
g/cm2 of L1-L4
|
9 months
|
Change in Finite Element Analysis of lumbar spine (L2)
Time Frame: 9 Months
|
Strength in Newtons
|
9 Months
|
Change in NTx bone resorption marker
Time Frame: 9 Months
|
nM and percent change
|
9 Months
|
Change in P1NP bone formation marker
Time Frame: 9 Months
|
pg/mL and percent change
|
9 Months
|
Change in Lean Mass
Time Frame: 9 Months
|
kg and % body weight as measured by DXA
|
9 Months
|
Change in Fat Mass
Time Frame: 9 Months
|
kg and % body weight as measured by DXA
|
9 Months
|
Change in Chair-Stands test performance
Time Frame: 9 Months
|
Change in time to sit-stand five times from a chair (seconds)
|
9 Months
|
Change in handgrip strength
Time Frame: 9 Months
|
Newtons
|
9 Months
|
Change in Gait-speed
Time Frame: 9 Months
|
Time to walk 20 meters (seconds)
|
9 Months
|
Change in volumetric BMD of the hip by CT scan
Time Frame: 9 months
|
g/cm3
|
9 months
|
Change in volumetric BMD of the spine (L1-L4) by CT scan
Time Frame: 9 months
|
g/cm3
|
9 months
|
Change in Weight
Time Frame: 9 months
|
pounds
|
9 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Feasibility: Proportion of participants completing 9 Month study visit requirements
Time Frame: 9 Months
|
Proportion of participants completing 9 Month study visit requirements
|
9 Months
|
Tolerance: total number of adverse events reported by participants in the active and in-active arms
Time Frame: 9 Months
|
Comparison of the total number of adverse events reported by participants in the active and in-active arms
|
9 Months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Laura D Bilek, PT, PhD, University of Nebraska
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2020
Primary Completion (Actual)
December 30, 2022
Study Completion (Actual)
December 30, 2022
Study Registration Dates
First Submitted
January 31, 2020
First Submitted That Met QC Criteria
February 18, 2020
First Posted (Actual)
February 21, 2020
Study Record Updates
Last Update Posted (Actual)
October 31, 2023
Last Update Submitted That Met QC Criteria
October 27, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0820-19-FB
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Interested researchers should contact the study PI for potential access to the research.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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