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Bisphosphonate

Risedronate for Bone Loss After Bariatric Surgery (WE RISE U01 Trial)

Phase 3
Recruiting
Led By Kristen Beavers, MD
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subjects who have had sleeve gastrectomy
Be older than 18 years old
Must not have
Unable to position on scanner independently.
Unstable gastric reflux requiring two or more additional doses per month of anti-reflux medication
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, month 6, month 12
Awards & highlights
Pivotal Trial

Summary

This trial will test whether the bisphosphonate drug risedronate can help prevent bone and muscle loss in people who have had vertical sleeve gastrectomy surgery.

Who is the study for?
This trial is for individuals who have undergone sleeve gastrectomy and are willing to follow the study procedures. They must be able to get themselves to study visits, weigh less than 450 lbs, and not require assistance with positioning on a scanner. Participants should not be in another research study or regularly use certain medications like growth hormones, steroids, or osteoporosis drugs.
What is being tested?
The trial is testing if risedronate can prevent bone and muscle loss after bariatric surgery. Over one year, participants will take either risedronate or a placebo pill monthly while being monitored through six visits and regular check-ins by the study team.
What are the potential side effects?
Risedronate may cause side effects such as digestive issues (like heartburn), muscle or joint pain, eye inflammation, or flu-like symptoms. Since it's designed to prevent bone breakdown, any unusual bone pain should be reported.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have had a sleeve gastrectomy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I need help to position myself on a medical scanner.
Select...
I need extra heartburn medication more than twice a month.
Select...
I regularly use growth hormones, oral steroids, or osteoporosis meds.
Select...
I cannot drive myself to study visits.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, month 6, month 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, month 6, month 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Total Hip Areal Bone Mineral Density (aBMD)
Secondary study objectives
Physical Function Measurement (Fast Walk)
Physical Function Measurement (Stair Climb)
Other study objectives
Biomarkers of Bone Turnover, Metabolism, and Bone-Muscle Crosstalk

Side effects data

From 2016 Phase 4 trial • 1366 Patients • NCT01709110
12%
Back pain
7%
Arthralgia
3%
Fall
1%
Humerus fracture
1%
Hip fracture
1%
Lumbar vertebral fracture
1%
Osteoarthritis
1%
Femur fracture
100%
80%
60%
40%
20%
0%
Study treatment Arm
Risedronate
Teriparatide

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: BisphosphonateExperimental Treatment1 Intervention
Participants in this arm will receive six months of 150 mg once monthly oral risedronate
Group II: PlaceboPlacebo Group1 Intervention
Participants in this arm will receive six months of placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Risedronate
2002
Completed Phase 4
~4420

Find a Location

Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor
1,395 Previous Clinical Trials
2,460,005 Total Patients Enrolled
2 Trials studying Osteoporosis
194 Patients Enrolled for Osteoporosis
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)NIH
496 Previous Clinical Trials
1,089,312 Total Patients Enrolled
40 Trials studying Osteoporosis
67,112 Patients Enrolled for Osteoporosis
Kristen Beavers, MDPrincipal InvestigatorWake Forest University Health Sciences
1 Previous Clinical Trials
150 Total Patients Enrolled

Media Library

Risedronate (Bisphosphonate) Clinical Trial Eligibility Overview. Trial Name: NCT04922333 — Phase 3
Osteoporosis Research Study Groups: Bisphosphonate, Placebo
Osteoporosis Clinical Trial 2023: Risedronate Highlights & Side Effects. Trial Name: NCT04922333 — Phase 3
Risedronate (Bisphosphonate) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04922333 — Phase 3
Osteoporosis Patient Testimony for trial: Trial Name: NCT04922333 — Phase 3
~117 spots leftby Apr 2027
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