Weight Loss With Risedronate for Bone Health (WERISE)

Wake Forest University (WFU)

Status and phase: Completed; Phase 4

Conditions: Weight Loss; Bariatric Surgery Candidate; Bone Loss

Treatments: Drug: Risedronate Sodium 150 MG; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03411902

IRB00048310

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 40 to 79 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

24 participants in 2 patient groups, including a placebo group

Risedronate

Active Comparator group

Description:

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

Treatment:

Drug: Risedronate Sodium 150 MG

Placebo

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo