- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03411902
Weight Loss With Risedronate for Bone Health (WERISE)
Effect of Bisphosphonate Use on Surgical Weight Loss Associated Bone Loss in Older Adults With Morbid Obesity
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
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North Carolina
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Winston-Salem, North Carolina, United States, 27106
- Wake Forest University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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:
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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:
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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
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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
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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
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Duel-energy x-ray absorptiometry (DXA)-Acquired Measure for Total Hip Density measured in g/cm^2
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Baseline and 24 weeks
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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
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Baseline and 24 weeks
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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
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24 weeks
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Kristen M Beavers, PhD, Wake Forest University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00048310
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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