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Bisphosphonate

Active Infusion for Bariatric Surgery Candidates

Phase 1 & 2

Waitlist Available

Led By Laura D Bilek, PT, PhD

Research Sponsored by University of Nebraska

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 9 months

Awards & highlights

Study Summary

This trial finds that zoledronic acid prevents bone loss in people who have bariatric surgery.

Eligible Conditions

Bariatric Surgery Candidates
Osteoporosis

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 9 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~9 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 9 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Hip Bone Mineral Density (BMD) by DXA

Secondary outcome measures

Change in Chair-Stands test performance

Change in Fat Mass

Change in Finite Element Analysis of lumbar spine (L2)

+9 more

Other outcome measures

Feasibility: 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

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Active InfusionActive Control1 Intervention

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.

Group II: Non-active InfusionPlacebo Group1 Intervention

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

Do I qualify?Apply below to find out

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

University of NebraskaLead Sponsor

539 Previous Clinical Trials

1,144,724 Total Patients Enrolled

1 Trials studying Bariatric Surgery Candidates

35 Patients Enrolled for Bariatric Surgery Candidates

Laura D Bilek, PT, PhDPrincipal InvestigatorUniversity of Nebraska

1 Previous Clinical Trials

12 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Active Infusion been the subject of any prior research initiatives?

"Currently, there are 36 studies of Active Infusion that are in progress with 8 trials reaching Phase 3. Of these studies, the majority (694 sites) is distributed worldwide while a handful can be found within Douliu, Yunlin County."

Answered by AI

What is the current participant count for this research endeavor?

"Sadly, this medical trial is not accepting any more candidates. It was first published on September 1st 2020 and last modified on November 8th 2022. Should you be seeking alternative studies, there are currently 113 clinical trials looking for participants with a diagnosis of bone resorption and 36 trials recruiting those undergoing active infusion therapy."

Answered by AI

What medical ailments can Active Infusion alleviate?

"Active Infusion is often administered to patients with solid tumors, but the medication can also be used in treatment of bone mineral density issues, chemotherapy-related side effects, and osteoporosis."

Answered by AI

Are enrollments still open for this experiment?

"The details available on clinicaltrials.gov indicate that this medical study, which began recruiting candidates on September 1st 2020 and last updated November 8th 2022, is currently not enrolling patients. However, there are 149 other trials across the world actively seeking participants at present."

Answered by AI

Recent research and studies

BMJ OpenJournal

Protocol for a Pilot Randomised Controlled Trial of Zoledronic Acid to Prevent Bone Loss Following Sleeve Gastrectomy Surgery

Flores, Laura E, Lynn Mack, Christopher Wichman, Ashley A Weaver, Vishal Kothari, and Laura D Bilek. 2021. “Protocol for a Pilot Randomised Controlled Trial of Zoledronic Acid to Prevent Bone Loss Following Sleeve Gastrectomy Surgery”. BMJ Open. BMJ. doi:10.1136/bmjopen-2021-057483.

clinicaltrials.govStudy

Healthy Body, Healthy Bones After Bariatric Surgery Trial

Laura D. Bilek, PhD, PT 2020. "Healthy Body, Healthy Bones After Bariatric Surgery Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04279392.