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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: Recruiting Phase 3 study of Bone Loss, sponsored by Wake Forest University Health Sciences.
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. According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
Acquired through DXA scans.
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 |
What NCT04922333 shows while recruiting
NCT04922333 is an interventional study that assigns participants to a tested intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, below the 242-participant average among 16 other Bone Loss trials with a reported enrollment target (17% lower).
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 a single indexed study location in 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.
Where NCT04922333's enrollment target sits among peer trials
200 4th of 16 higher than 13 of 16 other Bone Loss trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Bone Loss trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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