Weight Loss With Risedronate for Bone Health

NCT03411902 | Completed Phase 4 Results FDA Drug

• 1 other identifier: IRB00048310
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Bariatric Surgery Candidate; Bone Loss; Weight Loss

Keywords

Bone Health

Outcome Measures

Primary Outcomes (1)

• Number of Enrolled Participants That Completed All 24 Week Procedures

  24 weeks

Secondary Outcomes (6)

• Fat Pounds

  24 weeks

• Lean Pounds

  24 weeks

• Total Change in Femoral Neck Hip Density

  Baseline and 24 weeks

• Total Change in Lumbar Spine Density

  Baseline and 24 weeks

• Duel-energy X-ray Absorptiometry (DXA)-Acquired Measure for Ultradistal Radius (or UD Radius) Density

  24 weeks

Study Arms (2)

Risedronate

ACTIVE COMPARATOR

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

Drug: Risedronate Sodium 150 MG

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Risedronate Sodium 150 MG 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.

Also known as: Code A

Risedronate

Placebo 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.

Also known as: Code B

Placebo

Eligibility Criteria

• Age: 40 Years - 79 Years
• Gender Eligibility Details: Male and female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects planning a sleeve gastrectomy procedure
• yrs of age
• Willingness to provide informed consent
• Agreement to all study procedures and assessments

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• Wake Forest University: collaborator

Study Sites (1)

Wake Forest University

Winston-Salem, North Carolina, 27106, United States

Location

Related Publications (1)

• 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.

  PMID: 33103032 DERIVED

MeSH Terms

Conditions

Bone Diseases, Metabolic; Weight Loss

Interventions

Risedronic Acid

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Kristen Beavers
• Organization: Wake Forest School of Medicine

beaverkm@wfu.edu

336-758-5855

Study Officials

• Kristen M Beavers, PhD

  Wake Forest University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Both participant and research associate charged with administering medication or placebo capsules will be blinded.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: January 11, 2018
• First Posted: January 26, 2018
• Study Start: June 15, 2018
• Primary Completion: July 22, 2020
• Study Completion: July 22, 2020
• Last Updated: February 9, 2021
• Results First Posted: January 22, 2021

Record last verified: 2020-12

Locations

US (1)