Clinical trial NCT04279392
Conditions: Bariatric Surgery Candidate Bone Loss Bone Resorption
Sponsor: University of Nebraska
Start date: 2020-09-01; Completion date: 2022-12-30
Enrollment: 10 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

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.

Arms: arm 1: 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. arm 2: At 6 weeks post surgery, 100 ml of saline will be infused intravenously over a 15 minute time period.
Interventions: intervention 1: Zoledronic Acid 5 mg/Bag 100 ml Inj intervention 2: Placebos
Intervention descriptions: intervention 1: Zoledronic acid infusion intervention 2: Saline infusion

Protocol documents:
Prot_SAP_002.pdf: 
Feasibility of Bisphosphonate Use on Sleeve Gastrectomy Associated Bone Loss: 
Healthy Body, Healthy Bones Trial 
 
NCT04279392 
 
21 Apr 2021 
 
 
 
 


Protocol 
 
Summary 
 
One in three adults in the Unites 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 study’s primary goal 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 involving 20 
adult sleeve gastrectomy participants randomized to receive either a onetime zoledronic acid infusion or 
placebo. The hypothesis is 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. We will measure bone mineral density and bone turnover markers at baseline and 9 
months. The primary outcome is change in bone mineral density as measured by Dual-energy x-ray 
absorptiometry. Secondary outcomes are change in bone mineral density as measured by Quantitative 
Computed Tomography and change in the serum bone turnover markers, urinary collagen type 1 cross-
linked N-telopeptide (a bone formation marker), serum type 1 procollagen N-terminal (bone resorption 
marker), sclerostin, and osteocalcin. Specific Aim 2: To evaluate the feasibility of this trial in those who 
have undergone sleeve gastrectomy surgery. We will assess the feasibility of the intervention by 
documenting adverse events and compliance rates at each study time point. 
 
 
Purpose 
 
The purpose of this study is to evaluate the effect of zoledronic acid, a bisphosphonate medicine used 
for osteoporosis, in preventing bone loss after bariatric surgery. 
Specific Aim 1: determine the efficacy of zoledronic acid in preventing bone loss associated with 
sleeve gastrectomy (SG). 
Specific Aim 2: evaluate the safety and tolerance of zoledronic acid in populations who have 
undergone SG surgery. 
 
 
Background 
 
Bone loss is accelerated after sleeve gastrectomy (SG) procedures, which can lead to an increased 
incidence of fragility fractures. This problem is becoming increasingly more important as bariatric 
surgery rates continue to rise. Fragility fractures due to poor bone health, are a leading cause of 
morbidity in older adults. Observational studies link weight loss with a reduction in bone mineral density 
(BMD) and an increased fracture risk, regardless of initial body weight.  Dietary-induced weight loss 


interventions have also been associated with decreases in total hip BMD. Greater weight loss 
exacerbates this decline in BMD and subsequent risk of fracture. (Tirosh, 2015) Data collected in the year 
following bariatric surgery shows a rapid decline in BMD and a significant association between bariatric 
surgery and fracture risk. Emerging long-term data suggest that bone loss continues in these patients 
even after weight stabilizes, with elevated bone turnover markers seen up to five years post-surgical 
treatment and fracture risk remaining high in long-term follow up. While cardiovascular and metabolic 
health improve after bariatric surgery, patients are increasingly vulnerable to fracture and the associated 
disability and morbidity. Bariatric surgery irreversibly increases skeletal fragility and future fracture risk. 
Identifying effective interventions to minimize bone loss is crucial for comprehensive treatment of 
patients who undergo bariatric surgery. There are many available pharmacotherapeutic options to 
effectively treat low bone density and decrease fracture risk. These treatments include anti-resorptive 
agents, such as the bisphosphonate zoledronic acid, which inhibit osteoclast-mediated bone loss. 
Bisphosphonates have been well studied for safety and efficacy in the treatment of low bone density in 
non-surgical populations, but the question of whether these pharmacotherapies may benefit patients 
after surgical weight loss procedures still remains. Guidelines put forth by The American Association of 
Clinical Endocrinologists sparsely address bisphosphonate use after surgical weight loss, and further 
evidence is needed to provide robust recommendations for prevention of bone loss after bariatric 
procedures.  Weight loss is associated with a significant increase in bone resorption which is mediated by 
osteoclasts. This makes bisphosphonates an appropriate treatment choice. Thus, bisphosphonate use 
may prove to be an effective intervention for countering bone loss during active weight loss, which is 
critical in reducing long-term fracture risk in the bariatric surgery population. 
 
Bariatric surgery has resulted in remarkable cardiovascular and metabolic health improvements, but 
often this occurs at the expense of bone health. The full extent of the lifelong consequences of bone loss 
on quality of life and mobility are not known. This study is significant because it could provide evidence 
for use of an existing therapy to counteract bone loss seen in post-bariatric surgery patients. 
 
 
Methods 
 
Enrolled participants will have blood drawn from the to evaluate menopausal status in those < 60 years 
old. Study personnel will also collect and store serum at 80 degrees Celsius, for assay of bone turnover 
markers and metabolic regulator proteins at a later date. Analysis of bone formation markers including 
procollagen Type 1 N-TerminalPropeptide (P1NP) and bone resorption marker N-Terminal Telopeptide of 
Type 1 Collagen (CTX) will be performed via commercially available ELISA by our laboratory. Participants 
will complete three surveys at baseline. The first, the Human Activity Profile (HAP), is a 94-question 
physical activity survey used to assess routine physical activity. The second, the Knee Injury and 
Osteoarthritis Outcome Score (KOOS), will assess overall knee pain, function, and knee-associated 
problems. Participants will also complete a modified National Osteoporosis Foundation Calcium Intake 
Estimate to collect dietary calcium habits. Participants will then be asked to perform three tasks relating 
to muscle function and gait speed: hand grip test, repeated chair stands, and a four-meter gait speed 
test. Participants will be measured on a standard scale for weight and have their waist circumference 
measured by study personnel. 
 
Participants will obtain dual energy x-ray absorptiometry (DXA) scan or bone densitometry scan and a 
computed tomography (CT) scan at baseline. Bone density measurement (BDM) of the bilateral hips, 
spine, radius, proximal tibia as well as body composition will be measured by DXA. A CT scan of the spine 
and hip will be completed using the Mindway Phantom to assess bone density and bone structure, as 


well as abdominal composition. CT scans will be de-identified and transferred to Wake Forest University 
to complete analyses of the CT scans. 
 
All participants will receive calcium citrate and vitamin D supplements, with instructions for taking. 
Calcium, Vitamin D, and Bariatric ProCare multivitamins will be processed and dispensed by the research 
pharmacist. A total intake of 1200 mg of calcium will be prescribed throughout the entirely of the study. 
Participants with normal serum 25(OH)D will be prescribed 1000 IU Vitamin D. Participants with serum 
25(OH)D between 20-29mg/mL will be prescribed 2000 IU Vitamin D. Vitamin D will be prescribed for 
the pre-operative period. Following non-study surgery, participants will be instructed to take the 
Bariatric ProCare vitamins and calcium citrate, and to discontinue any remaining Vitamin D supplements. 
 
Participants will be contacted via email and phone as a reminder prior to their infusion date. They will be 
provided with an appointment reminder text and directions to the Clinical Research Center with 
instructions on what to expect at their study visit. Based on prior randomization, participants will receive 
either non-active saline (placebo) or active-medication (zoledronic acid) infusion. To minimize the risk of 
adverse effects of Zoledronic acid, all participants will have a baseline glomerular filtration rate (GFR) 
measured prior to infusion to ensure they have adequate kidney function. A stat blood draw with 
comprehensive metabolic panel will be ordered prior to the infusion. Those participants with glomerular 
filtration rate (GFR) less than 35mL/min or those with evidence of acute kidney impairment will not 
receive the treatment. A single dose of Zoledronic acid should not exceed 5mg, and the duration of 
infusion should be no less than 15 minutes. Therefore, infusion of both the active and non-active  
intervention will take place over 15 minutes. To minimize risk of adverse events such as anaphylaxis, a 
Clinical Research Center nurse will be present during the infusion and will monitor the patient for 15 
minutes after the infusion. Adverse events including potential infusion reaction and other side effects 
will be recorded by study personnel at the time of infusion. Participants will be provided with a take-
home sheet detailing common and/or expected reactions to the medication intervention, with 
instructions as to how to manage them. This sheet will be reviewed with the participant by study 
personnel, with ample time for questions. 
 
Participants will be contacted via text message, email or phone call 24-hours and 2-months following 
their infusion to collect and address any adverse events/reactions/concerns they may have. The contact 
will include a link to a RedCap survey to self-report adverse events. If contacted via phone, study 
personnel will complete the adverse events form with the participant. Participants will be contacted up 
to 3 times, with at least 24 hours between contact in the case of non- responders.  
 
Nine months post-bariatric surgery, participants will have a follow-up visit. Participants will be measured 
on a standard scale for weight and have their waist circumference measured. Participants will have blood 
drawn and serum will be stored at 80 degrees Celsius, for assay of bone turnover markers and metabolic 
regulator proteins at a later date. Analysis of bone formation markers including procollagen Type 1 N-
TerminalPropeptide(P1NP) and bone resorption marker N-Terminal Telopeptide of Type 1 Collagen (CTX) 
will be performed via commercially available ELISA by our laboratory. Participants will complete three 
surveys: the Human Activity Profile (HAP), is a 94-question physical activity survey used to assess routine 
physical activity; the Knee Injury and Osteoarthritis Outcome Score (KOOS), will assess overall knee pain, 
function, and knee-associated problems; and a modified National Osteoporosis Foundation Calcium 
Intake Estimate to collect dietary calcium habits. Participants will complete a hand grip test, repeated 
chair stands, and a 4-meter gait speed test. The National Osteoporosis Foundation Calcium Intake 
Estimate will be used post-operatively to gather data about calcium intake from diet. 
 


A whole body DXA scan will be obtained one month after follow-up visit to assess body composition and 
bone mineral density (BMD) of the hip, lumbar vertebrae (L1-L4), knee and radius. To minimize variability 
between baseline and follow-up scans, each participant  will be scanned on the exact same DXA scanner 
with identical scan parameters for each anatomic location. A real BMD (a BMD, g/cm2) will be  
determined from each scan. For the femoral scan, a BMD will  be calculated from the proximal femur 
using the scanners standard procedures. For the vertebral scan, a BMD will be calculated for each 
vertebral body and for all four combined using the scanners standard procedures. For the distal radius 
scan, a BMD will be calculated for the distal one-third of the radius using the scanners standard 
procedures. The DXA technologist will be blinded to treatment group for each subject. The whole body 
DXA also provides data on lean and fat mass, as well as distribution of these tissues. A CT scan of the 
lumbar vertebrae, hips and associated soft tissue will be obtained from one month after follow-up visit. 
To minimize variability between the baseline and follow-up scans, each participant will be scanned on 
the exact same CT scanner with identical scan parameters. 
 
 
Statistical Analysis 
 
In this pilot study, thirty participants will be enrolled: 15 randomized to the intervention group, and 15 
randomized to the control group with a goal of 10 participants completing the study in each group. Data 
gathered from this study will be used to complete sample size and power calculations for a larger 
randomized controlled trial. A sample size of 10 per group achieves 80% power to detect a difference of -
0.02 (correlation coefficient) between the null hypothesis correlation of 0.0 and the alternative 
hypothesis correlation of 0.02 using a two-sided hypothesis test with an estimated standard deviation of 
0.02 and with a significance level of 0.05 using a two-sided Wilcoxon test, assuming that the actual 
distribution is normal.  
 
Collection of study data is focused on feasibility and gathering evidence to inform future studies, thus, all 
analyses are considered exploratory rather than confirmatory. Baseline characteristics will be 
summarized using descriptive measures, both overall, by gender, and by group, at baseline. The primary 
outcome of feasibility will be based on retention of participants at follow-up visits and description of 
tolerance of the active and inactive group in response to infusion. Follow-up treatment effect estimates 
at 9 months will be used in power calculations for future clinical trials. Secondary analyses will examine 
change in bone metrics between groups assessed by a Students t-test. The effect of changes in relevant 
co-variates such as lean mass, muscle function and nutrition status on study outcomes will be assessed. 
Regression models will used to control for appropriate co-variates and further explore the 
effect of zoledronic acid on bone after bariatric surgery. 

ICF_003.pdf: 
 
Feasibility of Bisphosphonate Use on Sleeve Gastrectomy Associated Bone Loss: Healthy 
Body, Healthy Bones Trial 
 
NCT04279392 
 
21 Oct 2022 
 
 


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ADULT CONSENT - CLINICAL BIOMEDICAL 
Title of this Research Study 
Feasibility of Bisphosphonate Use on Sleeve Gastrectomy Associated Bone Loss: 
Healthy Body, Healthy Bones Trial 
 
Invitation and Summary 
 
You are invited to take part in this research study. Participation in this research study 
is voluntary. You do not have to take part. 
 
Here is a summary of the purpose, methods, risks, benefits, and alternatives, to help 
you decide whether or not to take part in the research. 
 
Weight-loss surgery is positive in many ways. It helps reduce obesity and obesity- 
related diseases. However, weight-loss surgery is known to have negative 
consequences on our bones. When our bones become unhealthy, we have an 
increased risk of breaking a bone. 
 
The purpose of this study is to see if a bone protecting medicine can help stop the 
bone loss that happens after weight-loss surgery. 
 
The study includes an assessment of your bones, diet, and physical health before 
your surgery and at 9 months after surgery. Six weeks after surgery you will receive 
an intravenous (IV) infusion of an active or inactive medication. An IV is a way to 
deliver fluids or medicine directly into your body through a vein. You will be randomly 
assigned to either the active intervention group or the non-active intervention group. 
You do not get to pick the group you are in. There is a 50% chance you will be 
placed in the active intervention group and a 50% chance you will be placed in the 
non-active intervention group. Both groups will receive an infusion, but one infusion 
delivers the intervention we are testing and one does not. The active intervention is a 
bone medicine called zoledronic acid, which is a medicine used to treat poor bone 
health. Because this study is "blinded" you are not told your group until the final study 
visit. 
 
When you enroll in this study you will have a bone scan of your spine, hip, knee, and 
arm, and a CT scan of your spine and hip. These are scans that help us measure the 
health of your bones. You will also have blood drawn to measure factors that tell us 
about the health of your bones. You will complete questionnaires, complete physical 
function assessments, and receive calcium and vitamin D supplements. The study 
will supply calcium to meet your daily needs. You will also receive vitamin D. The 


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amount of vitamin D supplements you receive will depend on your vitamin D labs. 
These supplements will be provided before your surgery. 
 
You will be provided with a bariatric vitamin for use following your surgical operation. 
You will continue on calcium supplements throughout the 9-month study period. At 
the study completion visit at 9-months after your operation, you will have your second 
bone scan and CT scan and complete all study questionnaires and physical function 
tests. If you want, you can find out to which group you were assigned at this time. 
 
There are risks associated with this study. The most important and likely risks come 
from the active intervention, which is a bone medicine called zoledronic acid. The 
bone medicine sometimes causes joint pain, muscle pain, headaches, and flu-like 
symptoms. There are other risks from the bone scans as well, such as radiation 
exposure. The risks will be described in greater detail later in the consent form. We 
take every action we can to make sure you are safe and the risks are low. 
 
The possible benefits of being in this study are that you may be able to prevent bone 
loss after your weight-loss surgery, if you are randomized to the active intervention. 
 
The alternatives to participating in this study are to not participate. Zoledronic acid 
can be prescribed by your doctor if they are concerned about your bone health. 
Vitamin D, calcium and a bariatric vitamin are available over the counter. You could 
also participate in a bone-loading exercise program that includes weight-lifting, and/or 
jumping exercises. 
 
 
Why are you being asked to be in this research study? 
You are invited to participate because: 
 You are 19 years of age or older 
 You are planning a sleeve gastrectomy procedure at Nebraska Medicine 
 If you are a woman, you are postmenopausal, or if you are pre-menopausal, 
you are incapable of childbearing or have a documented non-hormonal 
intrauterine device 
 You are less than 350 pounds 
 
 
What is the reason for doing this research study? 
Adults who undergo bariatric surgery are at risk for developing low bone mass and 
higher risk of breaking bones in the future. This research is trying to see if an 
osteoporosis medicine is effective in reducing bone loss and the risk of breaking 


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bones following bariatric surgery. 
 
All medicines and imaging tests in this study are FDA approved. 
 
What will be done during this research study? 
You have also received a timeline of events in this study to go along with the written 
descriptions below. 
 
Enrollment Visit: 
After the consent process you will complete several surveys. You will complete The 
National Osteoporosis Foundation Calcium Intake Estimate, which estimates the 
calcium in your diet. You will complete a physical activity survey called the Human 
Activity Profile (HAP), and a survey about your knee pain and function called the 
Knee Injury and Osteoarthritis Outcome Score (KOOS) at this visit. You will have two 
tubes (about 4 teaspoons) of blood drawn so we can measure factors which indicate 
how your bones are functioning. If you are a female less than 60, you will have an 
additional 2 teaspoons of blood drawn so we can also do a test to confirm you are in 
menopause. You will be asked to complete a hand grip test, sit and stand in a chair 
five times in a row, and walk 13 feet to evaluate your strength and walking function. 
Study personal will access your health record to get details about your surgery, other 
medical conditions, and medications you are taking. 
 
The enrollment visit should take about 1 hour in total. Study personnel will contact 
you via phone or email following the visit to schedule the remaining research visits. 
 
Bone Scans (Imaging Visit 1): The first imaging visit will take place at the Nebraska 
Medicine Village Pointe Location, before your surgery date. You will be measured on 
a standard scale for weight. You will also have your waist circumference measured 
by study personnel. You will have a DXA scan of your hips, lumbar spine, arm and 
knee. This scan also provides information about your body composition. You will also 
have a CT scan of your lumbar spine and hip which tells us about your muscles and 
bones. Based on results the vitamin D levels in your blood, you will be prescribed 
vitamin D supplements. You will be given 1200 mg calcium per day and will receive a 
9-month supply of the Bariatric ProCare vitamin along with instructions on how to 
take them following surgery. If you choose, research staff will send DXA bone scan 
results to your provider. 
 
This visit will take place before your bariatric operation and should take 
approximately 2.5 hours including driving time. You will be compensated for this visit. 


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Intervention/Infusion visit: You will return 6 weeks following your surgery for the 
intervention/infusion visit. We will do our best to schedule this visit with your bariatric 
surgery 6-week follow-up visit. 
 
The intervention/infusion visit will take place at the Nebraska Medicine Campus. You 
will first receive a blood draw when you arrive for your regularly scheduled 6-week 
follow up visit with your bariatric physician. Following your bariatric visit, you will go to 
the UNMC Clinical Research Center. At the Clinical Research Center, you will have 
your infusion. Based on which group you were assigned, you will receive either non- 
active saline intervention (placebo) or active intervention (zoledronic acid) 
intravenous (IV) infusion. An IV infusion is a method of delivering fluids or medicine 
directly into a vein. The infusion will take place over a minimum of 15 minutes, and 
we will ask you to remain in the Clinical Research Center for an additional 15 minutes 
following the infusion. Study personnel will ask you about side-effects you experience 
after the infusion. You will be provided with a take-home sheet detailing common 
and/or expected reactions to the intervention, with instructions about how to manage 
them. 
 
The intervention/infusion visit will take approximately 3 hours in total. You will be 
compensated for this visit. 
 
24 Hour Check in: You will be contacted (via text, email or phone) following the 
infusion to collect and address any adverse events/reactions/concerns you may 
have. 
 
2 Month Check in: 
You will be contacted (via text, email or phone) following the infusion to collect and 
address any adverse events/reactions/concerns you may have. 
 
Bone Scans (Imaging Visit 2): The final imaging visit will take place at the Nebraska 
Medicine Village Pointe location, 9-months after your surgery date, and serves as the 
completion of the study. The study completion visit is very similar to the first imaging 
visit before your surgery. At this visit you will have your weight, and waist 
circumference measured. You will have a second DXA scan, CT scan and 4 
teaspoons of blood drawn. You will complete the physical function tests (hand grip 
test, sit and stand in a chair five times in a row, and walk 13 feet), and all study 
questionnaires again. Since you will no longer receive study supplied calcium and 
vitamin D supplements, research staff will review the recommended amounts of 
calcium and vitamin D and bariatric vitamin supplementation for you to purchase and 


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continue taking. We will also provide information about how to take care of your 
bones. You can find out the group to which you were assigned if you wish. 
 
We will call after your visit to review the bone scan results will with you. 
 
The 9-month visit will take approximately two hours. You will be compensated for this 
visit. 
 
What are the possible risks of being in this research study? 
Zoledronic Acid (Active-intervention): The most commonly reported adverse effects of 
Zoledronic acid are fever (8.7%-17.9%), joint pain (17.9%-23.8%), high blood 
pressure (6.8%-12.7%), muscle pain (4.9%-11.7%), and headache (3.9%-12.4%). 
There are other rare, but serious side effects including renal impairment (kidney 
problems), kidney failure, severe bone, muscle and joint pain, injection site reactions 
(allergic reactions), anaphylaxis (severe allergic reaction), atrial fibrillation (heart 
condition) and osteonecrosis of the jaw (bone breakdown). 
 
Placebo (non-active intervention): The placebo medication used in this study (saline), 
has no known side effects. However, if you are not randomized to the active 
medication group, it is possible that you will not maintain the quality and strength of 
your bones over the study period. 
 
Bone Scans (DXA and CT): This research study involves exposure to radiation that is 
not necessary for your medical care and is for research purposes only. 
 
DXA: There are risks associated with radiation from DXA bone density testing. DXAs 
are safe, non-invasive and painless. Subjects will have two DXA scans (pre-op and 9 
months post-op). 
 
CT Scan: A CT scan is non-invasive and relatively painless. Risks associated with 
radiation from CT scan testing are more significant than DXA. CTs are safe, non- 
invasive and painless; however, they deliver a larger dose of ionizing radiation than 
traditional X-rays. 
 
Radiation Safety: This research study involves exposure to radiation. Please note 
that this study involves radiation exposure that is not necessary for your medical care 
and is for research purposes only. The total amount of radiation (2400 millirems) you 
will receive from participating in this study is about 48% of what radiation workers (for 
example, x-ray technicians) are allowed to receive annually. The risk is comparable 
to the risk of working in a "safe" industry, such as office work. Scientists disagree on 


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the exact risk of radiation doses at these levels. One possible effect could be a very 
slight increase in cancer risk. The increase with this amount of radiation is less than 1 
in 25,000 (much less than 1/100th of a percent). This additional risk is too small to be 
measured and is generally regarded as insignificant. 
 
Please tell your doctor if you have taken part in other research studies or received 
any medical care that used radiation (for example, any x-rays or nuclear medicine 
scans). This way we can make sure that you will not receive too much radiation. 
 
Peripheral intravenous (IV) placement: Risks associated with placement of an IV 
include discomfort, redness at IV site, bruising, IV fluid leaking into the surrounding 
tissues, air introduced into the vein, and phlebitis (inflammation of the vein). 
 
Please tell the researchers if you have taken part in other research studies or 
received any medical care that used radiation (for example, any x-rays or nuclear 
medicine scans). This way we can make sure that you will not receive too much 
radiation. 
 
Calcium and Vitamin D usage: Vitamin D supplements are relatively safe. Too much 
calcium can be harmful. Stomach upset, constipation, and kidney stones have 
occurred with high intakes of calcium; however, our study uses the recommended 
dose of calcium. You are encouraged to drink at least 8 glasses of water a day while 
you are taking calcium and vitamin D supplements. You should not take additional 
supplements of calcium and vitamin D supplements above those prescribed for the 
study. 
 
Blood Draw: Risks associated with drawing blood are minimal, with the most common 
being bruising and discomfort at the blood draw site. Sometimes, people become 
dizzy, lightheaded, or feel faint during or after a blood draw. A rare complication is 
infection at the venous access site. 
 
It is possible that other rare side effects could occur which are not described in this 
consent form. It is also possible that you could have a side effect that has not 
occurred before. There is always a risk of other side effects that we cannot predict. 
You will be asked to inform the research staff about all medications, vitamins, and 
supplements you take, and medical conditions. This may help avoid side effects, 
interactions, and other risks. 
 
What are the possible benefits to you? 
If you agree to take part in the study, you may or may not experience direct benefit. 


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The possible benefits of participating in this study may include a reduction in bone 
loss during the study period, which may be critical in reducing long-term fracture risk 
in bariatric surgery patients. As everyone may respond differently to therapy, there is 
no way to know in advance if this study will be beneficial in each individual case. 
 
What are the possible benefits to other people? 
We hope the information learned from this study could be used in developing a 
recommended protocol for patients who undergo bariatric surgery to maintain their 
bone health after bariatric surgery. 
 
What are the alternatives to being in this research study? 
The alternative to participating in this study is to not participate in this study, and 
receive standard of care, which is a recommendation from the healthcare provider to 
take a bariatric vitamin. Bariatric vitamins, Vitamin D, and Calcium are each available 
over the counter. Zoledronic Acid can be prescribed off study, if there is concern for 
bone loss. An additional alternative is to participate in a bone-loading exercise 
program, which might include weight lifting and jumping exercises.This study will 
provide the subject with the standard of care, and will provide education on bone 
preserving strategies. 
 
Alternatives for increasing bone health include participation in a weight-bearing and 
weight lifting exercise program, and medication. We encourage you to discuss 
options with your healthcare provider. 
 
Instead of being in this research study, you can choose not to participate. 
 
What will being in this research study cost you? 
There is no cost to you to be in this research study. 
 
Will you be paid for being in this research study? 
You will be paid to be in this research study. You will receive nominal monetary 
compensation for your time and expenses associated with study visits and time to 
administer treatments. Compensation is as follows: 
 
$50 for Imaging and blood collection Visit 1. 
$75 for the Infusion and Blood collection Visit. 
$50 for Imaging Visit 2. 
 
Payment will be in the form of Visa gift cards. You will also receive all study lab tests, 
bone scans, and vitamin and mineral supplementation (calcium, vitamin D and 


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bariatric vitamins) at no additional cost to you. 
 
Who is paying for this research? 
This research is being paid for by grant funds from the Society of Endoscopic and 
Gastrointestinal Surgeons (SAGES) and the Nebraska Medicine Research Support 
Fund. 
 
What should you do if you are injured or have a medical problem during this 
research study? 
Your welfare is the main concern of every member of the research team. If you are 
injured or have a medical problem as a direct result of being in this study, you should 
immediately contact one of the people listed at the end of this consent form. 
Emergency medical treatment for this injury or problem will be available at The 
Nebraska Medical Center. If there is not sufficient time, you should seek care from a 
local health care provider. 
 
Treatment and Compensation for Injury: If you are experiencing a medical 
emergency, please call 9-1-1. UNMC/Nebraska Medicine has no plans to pay for any 
required treatment or provide other compensation. Agreeing to this does not mean 
you have given up any of your legal rights. 
 
How will information about you be protected? 
You have rights regarding the protection and privacy of your medical information 
collected before and during this research. This medical information is called 
"protected health information" (PHI). PHI used in this study may include your medical 
record number, address, birth date, medical history, the results of physical exams, 
blood tests, x-rays as well as the results of other diagnostic medical or research 
procedures. Only the minimum amount of PHI will be collected for this research. Your 
research and medical records will be maintained in a secure manner. 
 
Who will have access to information about you? 
By signing this consent form, you are allowing the research team to have access to 
your PHI. The research team includes the investigators listed on this consent form 
and other personnel involved in this specific study at UNMC/Nebraska Medicine. 
 
Your PHI will be used only for the purpose(s) described in the section "What is the 
reason for doing this research study?" 
 
You are also allowing the research team to share your PHI, as necessary, with other 
people or groups listed below: 


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 The UNMC Institutional Review Board (IRB) 
 Institutional officials designated by the UNMC IRB 
 Federal law requires that your information may be shared with these groups: 
 The HHS Office for Human Research Protections (OHRP) 
 The Food and Drug Administration (FDA) 
 The HIPAA Privacy Rule requires the following groups to protect your PHI: 
 Researchers at UNMC/Nebraska Medicine involved in the study 
 Your health insurance company 
 
You are authorizing us to use and disclose your PHI for as long as the research 
study is being conducted. You may cancel your authorization for further collection of 
PHI for use in this research at any time by contacting the principal investigator in 
writing. However, the PHI which is included in the research data obtained to date 
may still be used. If you cancel this authorization, you will no longer be able to 
participate in this research. 
 
How will results of the research be made available to you during and after the 
study is finished? 
Information obtained in the course of the research that will not be shared with you is 
which group you are assigned to, the active medication group or the inactive 
medication group. By signing this authorization, you are temporarily giving up your 
right to see this research-related information while the research is going on. You will 
be able to see this information if you wish after the research is completed. 
 
What will happen if you decide not to be in this research study? 
You can decide not to be in this research study. Deciding not to be in this research 
will not affect your medical care or your relationship with the investigator or the 
Institution. Your doctor will still take care of you and you will not lose any benefits to 
which you are entitled. 
 
What will happen if you decide to stop participating once you start? 
You can stop participating in this research (withdraw) at any time by contacting the 
Principal Investigator or any of the research staff. Deciding to withdraw will otherwise 
not affect your care or your relationship with the investigator or this institution. You 
will not lose any benefits to which you are entitled. For your safety, please talk to the 
research team before you stop taking any study drugs or stop other related 
procedures. They will advise you how to withdraw safely. If you withdraw you may be 
asked to undergo some additional tests. You do NOT have to agree to do these 
tests. 


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You may be taken off the study if you do not follow instructions of the investigator or 
the research team. 
 
You may also be taken off the study if 
 You have a major surgical complication during or after your surgery including 
an anastomotic leak 
 You develop a diagnosis of osteoporosis 
 Your kidneys begin to function improperly 
 You are found to be pre-menopausal 
 You are prescribed a medication which affects bones 
 Your physician feels it is unsafe for you to continue in this trial 
 
 
Will you be given any important information during the study? 
You will be informed promptly if the research team gets any new information during 
this research study that may affect whether you would want to continue being in the 
study. 
 
What should you do if you have any questions about the study? 
You have been given a copy of "What Do I Need to Know Before Being in a 
Research Study?" If you have any questions at any time about this study, you should 
contact the Principal Investigator or any of the study personnel listed on this consent 
form or any other documents that you have been given. 
 
What are your rights as a research participant? 
You have rights as a research subject. These rights have been explained in this 
consent form and in The Rights of Research Subjects that you have been given. If 
you have any questions concerning your rights, or want to discuss problems, 
concerns, obtain information or offer input, or make a complaint about the research, 
you can contact any of the following: 
 The investigator or other study personnel 
 Institutional Review Board (IRB) 
 Telephone: (402) 559-6463 
 Email: IRBORA@unmc.edu 
 Mail: UNMC Institutional Review Board, 987830 Nebraska Medical 
Center, Omaha, NE 68198-7830 
 Research Subject Advocate 
 Telephone: (402) 559-6941 
 Email: unmcrsa@unmc.edu 


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Documentation of informed consent 
You are freely making a decision whether to be in this research study. Signing this 
form means that: 
 You have read and understood this consent form. 
 You have had the consent form explained to you. 
 You have been given a copy of The Rights of Research Subjects 
 You have had your questions answered. 
 You have decided to be in the research study. 
 If you have any questions during the study, you have been directed to talk to 
one of the investigators listed below on this consent form. 
 You will be given a signed and dated copy of this consent form to keep. 
 
 
Signature of Subject  
 
Date  
 
 
My signature certifies that all the elements of informed consent described on this 
consent form have been explained fully to the subject. In my judgment, the subject 
possesses the legal capacity to give informed consent to participate in this research 
and is voluntarily and knowingly giving informed consent to participate. 
 
Signature of Person obtaining consent  
 
Date  
 
 
Authorized Study Personnel 
Principal 
* Bilek, Laura 
phone: 402-559-6923 
alt #: 402-559-2470 
degree: PT, PhD 
 
Secondary 
* Kothari, Vishal 
phone: 402-559-6592 
alt #: 402-559-6592 
degree: MD 
 
Lead Coordinator 
Flores, Laura 
alt email: 575-621-7708 


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phone: 402-559-6923 
alt #: 402-552-6444 
degree: Medical Student 


 
This sheet will help you think of questions to ask the investigator or his/her 
staff. You should know all these answers before you decide about being in the 
research. 
Institutional Review Board (IRB) 
What Do I Need To Know 
Before Being In A Research Study? 
You have been invited to be in a research study. Research studies are also called 
"clinical trials" or "protocols." Research is an organized plan designed to get new 
knowledge about a disease or the normal function of the body. The people who are in 
the research are called research subjects. The investigator is the person who is 
running the research study. You will get information from the investigator and the 
research team, and then you will be asked to give your consent to be in the 
research. 
 
 
What is the purpose of the research? Why is the investigator doing the research? 
What are the risks of the research? What bad things could happen? 
What are the possible benefits of the research? How might this help me? 
 
How is this research different than the care or treatment I would get if I wasn t in 
the research? Are there other treatments I could get? 
 
Does everyone in this research study get the same treatment? 
Will being in the research cost me anything extra? 
Do I have to be in this research study? Will the doctor still take care of me if I say no? 
Can I stop being in the research once I ve started? How? 
Who will look at my records? 
 
How do I reach the investigator if I have more questions? 
 
Who do I call if I have questions about being a research subject? 
 
Make sure all your questions are answered before you decide whether or not to 
be in this research. 
 
 
 
 
 
 
Academic Research & Services Building 3000 / 987830 Nebraska Medical Center / Omaha NE 68198-7830 
402-559-6463 / FAX 402-559-3300 / Email: irbora@unmc.edu / http://www.unmc.edu/irb 


 
Institutional Review Board (IRB) 
THE RIGHTS OF RESEARCH SUBJECTS 
AS A RESEARCH SUBJECT YOU HAVE THE RIGHT 
 
to be told everything you need to know about the research before you are 
asked to decide whether or not to take part in the research study. The research 
will be explained to you in a way that assures you understand enough to decide 
whether or not to take part. 
 
to freely decide whether or not to take part in the research. 
 
to decide not to be in the research, or to stop participating in the research at 
any time. This will not affect your medical care or your relationship with the 
investigator or the Nebraska Medical Center. Your doctor will still take care of you. 
 
to ask questions about the research at any time. The investigator will answer 
your questions honestly and completely. 
 
to know that your safety and welfare will always come first. The investigator will 
display the highest possible degree of skill and care throughout this research. Any 
risks or discomforts will be minimized as much as possible. 
 
to privacy and confidentiality. The investigator will treat information about you 
carefully, and will respect your privacy. 
 
... to keep all the legal rights you have now. You are not giving up any of your 
legal rights by taking part in this research study. 
 
to be treated with dignity and respect at all times 
 
The Institutional Review Board is responsible for assuring that your rights and 
welfare are protected. If you have any questions about your rights, contact the 
Institutional Review Board at (402) 559-6463. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Academic Research & Services Building 3000 / 987830 Nebraska Medical Center / Omaha NE 68198-7830 
402-559-6463 / FAX 402-559-3300 / Email: irbora@unmc.edu / http://www.unmc.edu/irb