Bisphosphonate Use to Mitigate Bone Loss Secondary to Bariatric Surgery

Who is this study for? Patients with Bone Loss
What treatments are being studied? Risedronate
Status: Not yet recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Healthy Volunteers: No
View:

• Subjects who have had sleeve gastrectomy

• Willing to provide informed consent

• Agree to all study procedures and assessments.

Locations
United States
North Carolina
Wake Forest School of Medicine
Winston-salem
Contact Information
Primary
Kristen Beavers, MD
beaverkm@wfu.edu
336-758-5855
Time Frame
Start Date: January 2023
Estimated Completion Date: December 2024
Participants
Target number of participants: 200
Treatments
Experimental: Bisphosphonate
Participants in this arm will receive six months of 150 mg once monthly oral risedronate
Placebo Comparator: Placebo
Participants in this arm will receive six months of placebo
Authors
Kristen Beavers, Jamy Ard
Related Therapeutic Areas
Sponsors
Leads: Wake Forest University Health Sciences

This content was sourced from clinicaltrials.gov

Similar Clinical Trials