Weight Loss With Risedronate for Bone Health

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-15

Study Completion Date

2020-07-22

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.

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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.

Conditions

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Bariatric Surgery Candidate Bone Loss Weight Loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This pilot study is a RCT, involving 24 sleeve gastrectomy patients randomized to Risedronate or placebo capsules for 24 weeks

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Caregivers

Both participant and research associate charged with administering medication or placebo capsules will be blinded.

Study Groups

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Risedronate

Experimental: Risedronate sodium,150 mg capsule once every 4 weeks for 24 weeks.

Group Type ACTIVE_COMPARATOR

Risedronate Sodium 150 MG

Intervention Type DRUG

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.

Placebo

Active comparator: Identical 150 mg placebo capsules once every 4 weeks for 24 weeks.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type DRUG

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.

Intervention Type OTHER

Other Intervention Names

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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

Minimum Eligible Age

40 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes