NCT03411902

Weight Loss With Risedronate for Bone Health

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 40 Years – 79 Years
• Healthy volunteers: Accepted

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.

Conditions

• Bariatric Surgery Candidate
• Bone Loss
• Weight Loss

Interventions

Type	Name	Description
DRUG	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.
OTHER	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.

Timeline

• Start date: 2018-06-15
• Primary completion: 2020-07-22
• Completion: 2020-07-22
• First posted: 2018-01-26
• Last updated: 2021-02-09
• Results posted: 2021-01-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study