Weight Loss With Risedronate for Bone Health

Weight Loss Clinical Trial

— WERISE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03411902
• Other study ID #: IRB00048310
• Status: Completed
• Phase: Phase 4
• Start date: June 15, 2018
• Est. completion date: July 22, 2020

Study information

• Verified date: December 2020
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: July 22, 2020
• Est. primary completion date: July 22, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Bariatric Surgery Candidate
• Body Weight
• Bone Loss
• Weight Loss

Intervention

Drug:
• Risedronate Sodium 150 MG
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:
• Placebo
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.

Locations

Country	Name	City	State
United States	Wake Forest University	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	Wake Forest University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Enrolled Participants That Completed All 24 Week Procedures		24 weeks
Secondary	Fat Pounds	Duel-energy x-ray absorptiometry (DXA)-Acquired Measure--Fat pounds portion of Total body composition	24 weeks
Secondary	Lean Pounds	Duel-energy x-ray absorptiometry (DXA)-Acquired Measure--Lean pounds portion of Total body composition	24 weeks
Secondary	Total Change in Femoral Neck Hip Density	Duel-energy x-ray absorptiometry (DXA)-Acquired Measure for Total Hip Density measured in g/cm^2	Baseline and 24 weeks
Secondary	Total Change in Lumbar Spine Density	Duel-energy x-ray absorptiometry (DXA)-Acquired Measure for Lumbar Spine Density measured in g/cm^2	Baseline and 24 weeks
Secondary	Duel-energy X-ray Absorptiometry (DXA)-Acquired Measure for Ultradistal Radius (or UD Radius) Density	Total change in ultradistal radius density measure in g/cm^2	24 weeks
Secondary	Trabecular Bone Score (TBS)	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