Weight Loss With Risedronate for Bone Health

Phase 4

Completed

• Conditions: Bariatric Surgery Candidate; Bone Loss; Weight Loss
• Interventions: Drug: Risedronate Sodium 150 MG; Other: Placebo

• Registration Number: NCT03411902
• Lead Sponsor: Wake Forest University Health Sciences

Brief 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.

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 Timeline

• Study First Submitted: 2018-01-11
• Study First Submitted QC: 2018-01-19
• Study First Posted: 2018-01-26
• Study Start: 2018-06-15
• Primary Completion: 2020-07-22
• Study Completion: 2020-07-22
• Status Verified: 2020-12
• Results First Submitted: 2020-12-29
• Results First Submitted QC: 2020-12-29
• Last Update Submitted: 2021-01-21
• Results First Posted: 2021-01-22
• Last Update Posted: 2021-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Risedronate	Risedronate Sodium 150 MG	Experimental: Risedronate sodium,150 mg capsule once every 4 weeks for 24 weeks.
Placebo	Placebo	Active comparator: Identical 150 mg placebo capsules once every 4 weeks for 24 weeks.

Primary Outcome Measures

Name	Time	Method
Number of Enrolled Participants That Completed All 24 Week Procedures	24 weeks

Secondary Outcome Measures

Name	Time	Method
Fat Pounds	24 weeks	Duel-energy x-ray absorptiometry (DXA)-Acquired Measure--Fat pounds portion of Total body composition
Lean Pounds	24 weeks	Duel-energy x-ray absorptiometry (DXA)-Acquired Measure--Lean pounds portion of Total body composition
Total Change in Femoral Neck Hip Density	Baseline and 24 weeks	Duel-energy x-ray absorptiometry (DXA)-Acquired Measure for Total Hip Density measured in g/cm\^2
Total Change in Lumbar Spine Density	Baseline and 24 weeks	Duel-energy x-ray absorptiometry (DXA)-Acquired Measure for Lumbar Spine Density measured in g/cm\^2
Duel-energy X-ray Absorptiometry (DXA)-Acquired Measure for Ultradistal Radius (or UD Radius) Density	24 weeks	Total change in ultradistal radius density measure in g/cm\^2
Trabecular Bone Score (TBS)	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

Trial Locations

Locations (1)

Wake Forest University; 🇺🇸 Winston-Salem, North Carolina, United States