Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04279392
Other study ID # 0820-19-FB
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received
Last updated
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Recruiting NCT05650307 - CV Imaging of Metabolic Interventions
Not yet recruiting NCT05536466 - The Influence of Having Bariatric Surgery on the Pharmacokinetics, Safety and Efficacy of the Novel Non-nucleoside Reverse Transcriptase Inhibitor Doravirine N/A
Active, not recruiting NCT04583683 - Effects of Very Low Calorie Diet vs Metabolic Surgery on Weight Loss and Obesity Comorbidities N/A
Completed NCT04099654 - The Effect of Core Stabilization Exercise Program in Obese Subjects Awaiting Bariatric Surgery N/A
Completed NCT03809182 - Effect of Dexmedetomidine on Postoperative Glucose and Insulin Levels. Phase 4
Completed NCT03638843 - Endoscopic Gastric Mucosal Devitalization (GMD) as a Primary Obesity Therapy - Part 2 N/A
Withdrawn NCT05845359 - Intraoperative Methadone for Postoperative Pain Control Phase 4
Not yet recruiting NCT04343040 - Perioperative Evaluation of Glucose Profile Using Continuous Glucose Monitoring System in Glucose Intolerant Patients N/A
Withdrawn NCT03095404 - Intravenous Lidocaine for Post-Operative Pain Control in Patients Undergoing Bariatric Bowel Surgery Early Phase 1
Recruiting NCT03100292 - Korean OBEsity Surgical Treatment Study N/A
Active, not recruiting NCT04357119 - Common Limb Length in One-anastomosis Gastric Bypass N/A
Completed NCT03210207 - Gastric Plication in Mexican Patients N/A
Completed NCT04883268 - Focusing on Body Functionality After Bariatric Surgery N/A
Completed NCT02300168 - Neuromuscular Blockade: Outcome and Recovery for Laparoscopic Bariatric Surgery N/A
Unknown status NCT01264120 - The Impact of a Bariatric Rehabilitation Service on Patient Outcomes N/A
Recruiting NCT03972319 - Omega-3 Supplementation for LIver VolumE Reduction Study (OLIVER) Study Early Phase 1
Terminated NCT04626232 - Comparison of the Sleeve Gastrectomy Technique With a Nissen Fundoplication Added to the Conventional Sleeve Gastrectomy Technique in Morbidly Obese Patients N/A
Completed NCT03643783 - Impact of Plasma Soluble Prorenin Receptor in Obese and Type 2 Diabetic Patients
Completed NCT04219852 - Contraception and Bariatric Surgery: Evaluation of Contraception and Contraceptive Knowledge of Women Undergoing Bariatric Surgery at the University Hospital of Reims
Recruiting NCT05570474 - Effect of Protein Supplementation on Fat Free Mass Preservation After Bariatric Surgery N/A