Weight Loss With Risedronate for Bone Health (WERISE)

January 21, 2021 updated by: Wake Forest University Health Sciences

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

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 Overview

Detailed Description

This pilot study is a RCT, involving 24 participants randomized to Risedronate or placebo capsules for 24 weeks. All subjects planning a sleeve gastrectomy (SG) procedure will be approached during their pre-surgical evaluation for possible participation in the study. Eligible participants will be referred onto the study coordinator to read/sign an IRB-approved informed consent prior to enrollment.

Two in-person baseline assessment visits [baseline visit 1 (BV1), baseline visit 2 (BV2)] occurring 1-6 weeks prior to surgery, and two in-person follow up assessment visits [follow up visit 1 (FV1) and follow up visit 2 (FV2)] occurring ±2 weeks from their 23-week post-surgery date will be conducted, as well as monthly medication compliance reminders and adverse event reporting via phone. Optional additional exploratory assessments include CT-derive bone health and blood-based biomarkers, as well as 12-month DXA, CT, and blood assessments. The Wake Forest WMC, under the direction of Drs. Ard and Fernandez, will serve as a source of recruitment for potential study participants.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • North Carolina
      • Winston-Salem, North Carolina, United States, 27106
        • Wake Forest University

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.

Eligibility Criteria

Ages Eligible for Study

40 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

  • Subjects planning a sleeve gastrectomy procedure
  • 40-79 yrs of age
  • Willingness to provide informed consent
  • Agreement to all study procedures and assessments

Exclusion Criteria

  • Age <40 years
  • Baseline weight >450 pounds
  • Chronic anti-reflux treatment
  • History of medical disorders known to affect bone metabolism
  • Use of bone-active medications
  • Known allergy to Risedronate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Risedronate
Experimental: Risedronate sodium,150 mg capsule once every 4 weeks for 24 weeks.
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.
Other Names:
  • Code A
Placebo Comparator: Placebo
Active comparator: Identical 150 mg placebo capsules once every 4 weeks for 24 weeks.
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.
Other Names:
  • Code B

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Enrolled Participants That Completed All 24 Week Procedures
Time Frame: 24 weeks
24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fat Pounds
Time Frame: 24 weeks
Duel-energy x-ray absorptiometry (DXA)-Acquired Measure--Fat pounds portion of Total body composition
24 weeks
Lean Pounds
Time Frame: 24 weeks
Duel-energy x-ray absorptiometry (DXA)-Acquired Measure--Lean pounds portion of Total body composition
24 weeks
Total Change in Femoral Neck Hip Density
Time Frame: Baseline and 24 weeks
Duel-energy x-ray absorptiometry (DXA)-Acquired Measure for Total Hip Density measured in g/cm^2
Baseline and 24 weeks
Total Change in Lumbar Spine Density
Time Frame: Baseline and 24 weeks
Duel-energy x-ray absorptiometry (DXA)-Acquired Measure for Lumbar Spine Density measured in g/cm^2
Baseline and 24 weeks
Duel-energy X-ray Absorptiometry (DXA)-Acquired Measure for Ultradistal Radius (or UD Radius) Density
Time Frame: 24 weeks
Total change in ultradistal radius density measure in g/cm^2
24 weeks
Trabecular Bone Score (TBS)
Time Frame: 24 weeks
TBS of the lumbar spine measured by two dimensional (2D) variogram acquired through duel-energy x-ray absorptiometry (DXA). Trabecular bone score is a unitless index of bone microarchitecture. A high TBS value means that bone microarchitecture is dense and well connected, with little space between trabeculae. The following normal range for TBS values in postmenopausal women has been proposed: TBS >=1.350 is considered to be normal; TBS between 1.200 and 1.350 is considered to be consistent with partially degraded microarchitecture; and TBS <=1.200 defines degraded microarchitecture
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Kristen M Beavers, PhD, Wake Forest University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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 Major Dates

Study Start (Actual)

June 15, 2018

Primary Completion (Actual)

July 22, 2020

Study Completion (Actual)

July 22, 2020

Study Registration Dates

First Submitted

January 11, 2018

First Submitted That Met QC Criteria

January 19, 2018

First Posted (Actual)

January 26, 2018

Study Record Updates

Last Update Posted (Actual)

February 9, 2021

Last Update Submitted That Met QC Criteria

January 21, 2021

Last Verified

December 1, 2020

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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