Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04922333 · ClinicalTrials.gov registry record · Phase 3
Bisphosphonate Use to Mitigate Bone Loss Secondary to Bariatric Surgery
A Phase 3 study of Bone Loss, sponsored by Wake Forest University Health Sciences.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 200
- Enrollment target
- 1
- Study location
NCT04922333 is a Phase 3 study of Bone Loss that is actively recruiting participants, run by Wake Forest University Health Sciences. The registered enrollment target is 200 participants, below the 242-participant average among 16 other Bone Loss trials with a reported enrollment target (17% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04922333, a Phase 3 study of Bone Loss, is actively recruiting participants, sponsored by Wake Forest University Health Sciences.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 200 participants
- Enrollment target
- 1
- Study location
Study 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 Studied
Interventions
- DRUG Placebo
- DRUG Risedronate
Study Locations (1)
North Carolina
- Wake Forest School of Medicine - Winston-Salem
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2023-03-28 |
| Est. Completion | 2028-04-30 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04922333
The ClinicalTrials.gov registry entry for NCT04922333 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 242-participant average among 16 other Bone Loss trials with a reported enrollment target (17% lower). The listed sponsor is Wake Forest University Health Sciences, which has 1,140 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Bone Loss appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04922333 reports 1 study location spanning 1 distinct geographic area - top geographies include North Carolina.
Frequently Asked Questions
What is clinical trial NCT04922333 about?
NCT04922333 is a clinical study titled "Bisphosphonate Use to Mitigate Bone Loss Secondary to Bariatric Surgery". 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 a...
What is the current status of trial NCT04922333?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 200 participants. The study started on 2023-03-28. Estimated completion is 2028-04-30.
What conditions does trial NCT04922333 study?
This clinical trial studies the following conditions: Bone Loss.
What interventions are being tested in trial NCT04922333?
The interventions under investigation include: Placebo (DRUG), Risedronate (DRUG).
Who is sponsoring clinical trial NCT04922333?
This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04922333 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Bone Loss
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Bone, Exercise, Alendronate, and Caloric Restriction
RECRUITING · Phase 4
-
Skeletal Effects of Type 1 Diabetes on Low-Trauma Fracture Risk
RECRUITING
-
Bone in CKD Alkali Response (BICARb Pilot Trial)
RECRUITING · Phase 2
-
Ridge Augmentation Using Allograft Particles Hydrated With or Without Recombinant Human Platelet-Derived Growth Factor
RECRUITING · NA
-
Lutein, Zeaxathin, and Fish Oil Supplementation
RECRUITING · NA
-
LF111 or Drospirenone Chew vs Non-hormonal Contraceptive Methods on Bone Mineral Density in Adolescent and Adult Women
RECRUITING · Phase 4
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.