Recruiting
Phase 3

Bisphosphonate

Sponsor:

Wake Forest University Health Sciences

Code:

NCT04922333

Conditions

Bone Loss

Eligibility Criteria

Sex: All

Age: 30+

Healthy Volunteers: Not accepted

Interventions

Risedronate

Placebo

Study Details

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

Study ID

NCT04922333

Start date

Mar 28, 2023

Status verified date

Dec, 2025

Completion date

Apr 30, 2028

Anticipated

Primary completion date

Apr 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 30+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Bisphosphonate

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

placebo comparator: Placebo

Participants in this arm will receive six months of placebo

Interventions

Risedronate

150mg over-encapsulated risedronate

Placebo

Capsules containing placebo tablets

Primary outcome measure

  • Change in Total Hip Areal Bone Mineral Density (aBMD) [ Time Frame: baseline through Month 6 ]
  • Change in Total Hip Areal Bone Mineral Density (aBMD) [ Time Frame: baseline through Month 12 ]

Central Contacts and Locations

Central contacts

Kristen Beavers, PhD, MPH, RD

336-758-5855beaverkm@wfu.edu

Locations

Wake Forest School of Medicine

Recruiting

Winston-Salem, North Carolina, United States, 27157

Contacts

Principal Investigator:

Kristen Beavers, PhD, MPH, RD

More Information

Sponsor

Wake Forest University Health Sciences

Last update posted

Feb 19, 2026

Last verified

Dec, 2025

Keywords

  • bariatric surgery
  • bisphosphonate
  • mitigate bone loss

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Wake Forest University Health Sciences on 2026-02-19.