CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 24 enrolled
Drug / intervention
Risedronate Sodium 150 MG +1 moredrug
Likely dose
Risedronate Sodium 150 MGfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03411902
NCT03411902Phase 4Completed

Effect of Bisphosphonate Use on Surgical Weight Loss Associated Bone Loss in Older Adults With Morbid Obesity

Wake Forest University Health Sciences·interventional·Posted Jan 26, 2018·Updated Feb 9, 2021

In Brief

A Phase 4 clinical trial evaluating Risedronate Sodium 150 MG and Placebo for Bariatric Surgery Candidate and 2 related conditions. Completed, enrolled 24 participants across 1 site.

Detailed Summary

This is a pilot project to determine the feasibility of recruiting, enrolling, treating, and following 24 older sleeve gastrectomy patients into a randomized controlled trial (RCT) examining the efficacy of bisphosphonate use versus placebo in the prevention of surgical weight loss associated loss of bone mass and quality.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 4CompletedFinished
201820192020202120222023202420252026
First PostedJan 26, 2018
Enrollment StartJun 15, 2018
Primary CompletionJul 22, 2020
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 8.4 years ago

Interventions

Risedronate Sodium 150 MGdrug

Subjects randomized to the Risedronate group will take a 150 mg capsule of oral Risedronate once every 4 weeks for 24 weeks (6 doses), beginning 1 week prior to surgery and dispensed in blinded capsules from the WFSM research pharmacy.

Placeboother

Participants randomized to the placebo group will receive 150 mg placebo capsule once every 4 weeks for 24 weeks (6 doses), beginning 1 week prior to surgery and dispensed in blinded capsules from the WFSM research pharmacy.