RECRUITING

Bisphosphonate Use to Mitigate Bone Loss Secondary to Bariatric Surgery

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this research study is to see whether receiving a bisphosphonate medication called risedronate can reduce bone and muscle loss following bariatric surgery. Participation will involve up to 6 study visits and last about 1 year. Risedronate is a medication that prevents bone breakdown and has been approved by the US Food and Drug Administration (FDA) for the prevention and treatment of osteoporosis in older men and women. However, risedronate has not been approved for the prevention of bone and muscle loss following vertical sleeve gastrectomy. Participation in this study will involve completing two visits before beginning the intervention. Participants who qualify will be scheduled to begin the intervention program which will involve taking 6 monthly doses of a risedronate or placebo pill. Participants will then receive monthly contacts by study staff during this time to remind participants to take the intervention pill and ask about any adverse events. After the completion of intervention period, participants will complete up to 4 follow up study visits at 6 months (2 visits) and at 12 months (2 visits).

Official Title

Bisphosphonate Use to Mitigate Bone Loss Secondary to Bariatric Surgery

Quick Facts

Study Start:2023-03-28
Study Completion:2027-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04922333

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.

Ages Eligible for Study:40 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Subjects who have had sleeve gastrectomy
  2. * Willing to provide informed consent
  3. * Agree to all study procedures and assessments.
  1. * Weight greater than 450 lbs
  2. * Regular use of growth hormones, oral steroids, or prescription osteoporosis medications;
  3. * Known allergies to bisphosphonates
  4. * Unstable gastric reflux requiring two or more additional doses per month of anti-reflux medication.
  5. * Current participation in other research study
  6. * Unable to provide own transportation to study visits
  7. * Unable to position on scanner independently.

Contacts and Locations

Study Contact

Kristen Beavers, PhD, MPH, RD
CONTACT
336-758-5855
beaverkm@wfu.edu

Principal Investigator

Kristen Beavers, PhD, MPH, RD
PRINCIPAL_INVESTIGATOR
Wake Forest University Health Sciences
Jamy Ard, MD
PRINCIPAL_INVESTIGATOR
Wake Forest University Health Sciences

Study Locations (Sites)

Wake Forest School of Medicine
Winston-Salem, North Carolina, 27157
United States

Collaborators and Investigators

Sponsor: Wake Forest University Health Sciences

  • Kristen Beavers, PhD, MPH, RD, PRINCIPAL_INVESTIGATOR, Wake Forest University Health Sciences
  • Jamy Ard, MD, PRINCIPAL_INVESTIGATOR, Wake Forest University Health Sciences

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 Registration Dates

Study Start Date2023-03-28
Study Completion Date2027-04

Study Record Updates

Study Start Date2023-03-28
Study Completion Date2027-04

Terms related to this study

Keywords Provided by Researchers

  • bariatric surgery
  • bisphosphonate
  • mitigate bone loss

Additional Relevant MeSH Terms

  • Bone Loss