Clinical trial NCT03411902: Weight Loss With Risedronate for Bone Health
Official title: Effect of Bisphosphonate Use on Surgical Weight Loss Associated Bone Loss in Older Adults With Morbid Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Bariatric Surgery Candidate
Bone Loss
Weight Loss
Keywords: Bone Health
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: Wake Forest University
First posted: 2018-01-26
Enrollment: 24
Sex: ALL
Minimum age (years): 40
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This pilot study is a RCT, involving 24 sleeve gastrectomy patients randomized to Risedronate or placebo capsules for 24 weeks
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Enrolled Participants That Completed All 24 Week Procedures
timeFrame: 24 weeks
Secondary outcomes:
measure: Fat Pounds
timeFrame: 24 weeks
measure: Lean Pounds
timeFrame: 24 weeks
measure: Total Change in Femoral Neck Hip Density
timeFrame: Baseline and 24 weeks
measure: Total Change in Lumbar Spine Density
timeFrame: Baseline and 24 weeks
measure: Duel-energy X-ray Absorptiometry (DXA)-Acquired Measure for Ultradistal Radius (or UD Radius) Density
timeFrame: 24 weeks
measure: Trabecular Bone Score (TBS)
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University
state: North Carolina
Study officials:
affiliation: Wake Forest University
name: Kristen M Beavers, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Swafford AA, Ard JD, Beavers DP, Gearren PC, Fernandez AZ, Ford SA, Greene KA, Kammire DE, Nesbit BA, Reed KK, Weaver AA, Beavers KM. Risedronate to Prevent Bone Loss After Sleeve Gastrectomy: Study Design and Feasibility Report of a Pilot Randomized Controlled Trial. JBMR Plus. 2020 Oct 2;4(10):e10407. doi: 10.1002/jbm4.10407. eCollection 2020 Oct.