Bisphosphonate Use to Mitigate Bone Loss Secondary to Bariatric Surgery

NCT04922333 | Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: IRB00074763U01AR080969
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research study is to see whether receiving a bisphosphonate medication called risedronate can reduce bone and muscle loss following bariatric surgery. Participation will involve up to 6 study visits and last about 1 year. Risedronate is a medication that prevents bone breakdown and has been approved by the US Food and Drug Administration (FDA) for the prevention and treatment of osteoporosis in older men and women. However, risedronate has not been approved for the prevention of bone and muscle loss following vertical sleeve gastrectomy. Participation in this study will involve completing two visits before beginning the intervention. Participants who qualify will be scheduled to begin the intervention program which will involve taking 6 monthly doses of a risedronate or placebo pill. Participants will then receive monthly contacts by study staff during this time to remind participants to take the intervention pill and ask about any adverse events. After the completion of intervention period, participants will complete up to 4 follow up study visits at 6 months (2 visits) and at 12 months (2 visits).

Conditions

Bone Loss

Keywords

bariatric surgery; bisphosphonate; mitigate bone loss

Outcome Measures

Primary Outcomes (2)

• Change in Total Hip Areal Bone Mineral Density (aBMD)

  Acquired through DXA scans.

  baseline through Month 6

• Change in Total Hip Areal Bone Mineral Density (aBMD)

  Acquired through DXA scans.

  baseline through Month 12

Secondary Outcomes (14)

• Dual Energy X-Ray Absorptiometry (DXA)-acquired Femoral Neck Measurements

  Baseline, Month 6, Month 12

• DXA-acquired Lumbar Spine Measurements

  Baseline, Month 6, Month 12

• DXA-acquired Distal Radius Areal BMD Measurements

  Baseline, Month 6, Month 12

• DXA-acquired Appendicular Lean Mass Measurements

  Baseline, Month 6, Month 12

• Quantitative Computed Tomography (QCT) Acquired Compartmental Volumetric BMD (hip) Measurement

  Baseline, Month 6, Month 12

Other Outcomes (12)

• Biomarkers of Bone Turnover, Metabolism, and Bone-Muscle Crosstalk

  Baseline, Month 6, Month 12

• High Resolution peripheral Quantitative Computed Tomography (HRpQCT)-Acquired Distal Tibia Failure Load

  Baseline, Month 6, Month 12

• HRpQCT-Acquired Distal Tibia Bones Stiffness

  Baseline, Month 6, Month 12

Study Arms (2)

Bisphosphonate

EXPERIMENTAL

Participants in this arm will receive six months of 150 mg once monthly oral risedronate

Drug: Risedronate

Placebo

PLACEBO COMPARATOR

Participants in this arm will receive six months of placebo

Drug: Placebo

Interventions

Risedronate DRUG

150mg over-encapsulated risedronate

Also known as: Actonel, Atelvia

Bisphosphonate

Placebo DRUG

Capsules containing placebo tablets

Placebo

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects who have had sleeve gastrectomy
• Willing to provide informed consent
• Agree to all study procedures and assessments.

You may not qualify if:

• Weight greater than 450 lbs
• Regular use of growth hormones, oral steroids, or prescription osteoporosis medications;
• Known allergies to bisphosphonates
• Unstable gastric reflux requiring two or more additional doses per month of anti-reflux medication.
• Current participation in other research study
• Unable to provide own transportation to study visits
• Unable to position on scanner independently.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator

Study Sites (1)

Wake Forest School of Medicine

Winston-Salem, North Carolina, 27157, United States

RECRUITING

MeSH Terms

Conditions

Bone Diseases, Metabolic

Interventions

Risedronic Acid

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Kristen Beavers, PhD, MPH, RD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

• Jamy Ard, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kristen Beavers, PhD, MPH, RD

CONTACT

336-758-5855; beaverkm@wfu.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Both participants and study staff will be blinded to treatment allocation.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2021
• First Posted: June 10, 2021
• Study Start: March 28, 2023
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): April 30, 2028
• Last Updated: February 19, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)