Weight Loss With Risedronate for Bone Health

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Bariatric Surgery Candidate, Bone Loss, Weight Loss

Intervention / Treatment
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* Drug: Risedronate Sodium 150 MG
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This pilot study is a RCT, involving 24 sleeve gastrectomy patients randomized to Risedronate or placebo capsules for 24 weeks
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Risedronate<br>Experimental: Risedronate sodium,150 mg capsule once every 4 weeks for 24 weeks. | Drug: Risedronate Sodium 150 MG<br>* 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.<br>* Other names: Code A;|
| Placebo Comparator: Placebo<br>Active comparator: Identical 150 mg placebo capsules once every 4 weeks for 24 weeks. | Other: Placebo<br>* 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.<br>* Other names: Code B;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Enrolled Participants That Completed All 24 Week Procedures |  | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fat Pounds | Duel-energy x-ray absorptiometry (DXA)-Acquired Measure--Fat pounds portion of Total body composition | 24 weeks | 
| Lean Pounds | Duel-energy x-ray absorptiometry (DXA)-Acquired Measure--Lean pounds portion of Total body composition | 24 weeks | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bone Health