Healthy Body, Healthy Bones After Bariatric Surgery Trial

Sponsor

University of Nebraska (Other)

Overall Status

Recruiting

CT.gov ID

NCT04279392

Collaborator

(none)

Enrollment

Location

Arms

33.9

Anticipated Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Condition or Disease	Intervention/Treatment	Phase
Bariatric Surgery Candidate Bone Loss Bone Resorption	Drug: Zoledronic Acid 5 mg/Bag 100 ml Inj Drug: Placebos	Phase 1/Phase 2

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 Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

In this randomized controlled trial each subject will be randomized (1:1, block randomization with a block size of 10) to one treatment group (Active or Inactive treatment) and will be considered part of the intent-to-treat (ITT) cohort. The research pharmacist will be responsible for completing the randomization process, and will hold the group assignment data. All other study personnel will be blinded to group assignment.In this randomized controlled trial each subject will be randomized (1:1, block randomization with a block size of 10) to one treatment group (Active or Inactive treatment) and will be considered part of the intent-to-treat (ITT) cohort. The research pharmacist will be responsible for completing the randomization process, and will hold the group assignment data. All other study personnel will be blinded to group assignment.

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

The research pharmacist will deliver the drug pr placebo to the treatment nurse in an unlabeled 100 ml saline bag for infusion.

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Sep 1, 2020

Anticipated Primary Completion Date :

Dec 30, 2022

Anticipated Study Completion Date :

Jun 30, 2023

Arms and Interventions

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.	Drug: Zoledronic Acid 5 mg/Bag 100 ml Inj Zoledronic acid infusion Other Names: Reclast
Placebo Comparator: Non-active Infusion At 6 weeks post surgery, 100 ml of saline will be infused intravenously over a 15 minute time period.	Drug: Placebos Saline infusion

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.

Drug: Zoledronic Acid 5 mg/Bag 100 ml Inj

Zoledronic acid infusion

Other Names:

Reclast

Placebo Comparator: Non-active Infusion

At 6 weeks post surgery, 100 ml of saline will be infused intravenously over a 15 minute time period.

Drug: Placebos

Saline infusion

Outcome Measures

Primary Outcome Measures

Change in Hip Bone Mineral Density (BMD) by DXA [9 months]
g/cm2

Secondary Outcome Measures

Change in Lumbar spine bone mineral density (BMD) by DXA [9 months]
g/cm2 of L1-L4
Change in Finite Element Analysis of lumbar spine (L2) [9 Months]
Strength in Newtons
Change in NTx bone resorption marker [9 Months]
nM and percent change
Change in P1NP bone formation marker [9 Months]
pg/mL and percent change
Change in Lean Mass [9 Months]
kg and % body weight as measured by DXA
Change in Fat Mass [9 Months]
kg and % body weight as measured by DXA
Change in Chair-Stands test performance [9 Months]
Change in time to sit-stand five times from a chair (seconds)
Change in handgrip strength [9 Months]
Newtons
Change in Gait-speed [9 Months]
Time to walk 20 meters (seconds)
Change in volumetric BMD of the hip by CT scan [9 months]
g/cm3
Change in volumetric BMD of the spine (L1-L4) by CT scan [9 months]
g/cm3
Change in Weight [9 months]
pounds

Other Outcome Measures

Feasibility: Proportion of participants completing 9 Month study visit requirements [9 Months]
Proportion of participants completing 9 Month study visit requirements
Tolerance: total number of adverse events reported by participants in the active and in-active arms [9 Months]
Comparison of the total number of adverse events reported by participants in the active and in-active arms

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bariatric Center, Nebraska Medicine	Omaha	Nebraska	United States	68198

Sponsors and Collaborators

University of Nebraska

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Laura D. Bilek, PhD, PT, Associate Professor, University of Nebraska

ClinicalTrials.gov Identifier:

NCT04279392

Other Study ID Numbers:

820-19-FB

First Posted:

Feb 21, 2020

Last Update Posted:

Nov 10, 2021

Last Verified:

Nov 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Bone Resorption

Zoledronic Acid

Study Results

No Results Posted as of Nov 10, 2021