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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, month 6, month 12
Awards & highlights

WE RISE U01 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.Check my eligibility
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.See study design
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.

WE RISE U01 Trial Eligibility Criteria

Inclusion Criteria

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

WE RISE U01 Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Total Hip Areal Bone Mineral Density (aBMD)
Secondary outcome measures
DXA-acquired Appendicular Lean Mass Measurements
DXA-acquired Distal Radius Areal BMD Measurements
DXA-acquired Lumbar Spine Measurements
+11 more
Other outcome measures
Biomarkers of Bone Turnover, Metabolism, and Bone-Muscle Crosstalk
HRpQCT-Acquired Distal Radius Bone Stiffness
HRpQCT-Acquired Distal Radius Failure Load
+9 more

Side effects data

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

WE RISE U01 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
1,242 Previous Clinical Trials
1,004,286 Total Patients Enrolled
2 Trials studying Osteoporosis
194 Patients Enrolled for Osteoporosis
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)NIH
484 Previous Clinical Trials
1,086,645 Total Patients Enrolled
37 Trials studying Osteoporosis
40,420 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the common side effects associated with Risedronate?

"Risedronate has been studied in multiple Phase 3 clinical trials, meaning that there is some evidence of efficacy and extensive data supporting its safety. Consequently, our team at Power has rated Risedronate as a 3 on our safety scale."

Answered by AI

Is Risedronate a common medication tested in similar medical studies?

"Currently, 3 studies are underway that focus on Risedronate. 1 of these trials is in its final stage. The majority of the research being conducted is based out of Winston-Salem, North carolina; however, there are 4 locations running these sorts of tests."

Answered by AI

Are patients being enrolled in this clinical trial at this time?

"Unfortunately, this particular trial is not currently searching for any new participants. Although, it's worth noting that the last update to this study was on September 28th, 2022. There are presently 65 clinical trials actively recruiting patients with osteopenia and 3 trials specifically for Risedronate that are admitting new patients right now."

Answered by AI

How many people are being given the opportunity to participate in this clinical trial?

"At the moment, this particular study is not recruiting patients. Although, it was first posted on November 1st 2022 and last updated less than a month ago on September 28th. There are currently 65 trials actively searching for participants with osteopenia and 3 trials for Risedronate that are still looking for recruits."

Answered by AI

What are the FDA-approved indications for Risedronate?

"Osteoporosis is most commonly treated using Risedronate; however, this medication can also ameliorate symptoms associated with postmenopause, malignant neoplasms, and problems with bones."

Answered by AI

Who else is applying?

What state do they live in?
California
What site did they apply to?
Wake Forest School of Medicine
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
1

Why did patients apply to this trial?

Trying Fosamax for 15+ years, which is the max you can take it. Looking for something to continue with.
PatientReceived no prior treatments

What questions have other patients asked about this trial?

Will there be testing with dried prunes?
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Bisphosphonate Use to Mitigate Bone Loss Secondary to Bariatric Surgery
2023. "Bisphosphonate Use to Mitigate Bone Loss Secondary to Bariatric Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04922333.
All > Osteoporosis High Point > Osteoporosis
~133 spots leftby Apr 2027
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