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NCT04233112 · ClinicalTrials.gov registry record · Early Phase 1
Melatonin and Osteogenic Loading on Osteopenia
A Early Phase 1 study of Osteopenia, sponsored by Duquesne University.
- Active
- Registry status
- Early Phase 1
- Development phase
- 40
- Enrollment target
- 2
- Study locations
NCT04233112: Active Early Phase 1 study of Osteopenia, sponsored by Duquesne University.
NCT04233112 is a Early Phase 1 study of Osteopenia that is active but no longer recruiting, run by Duquesne University. The registered enrollment target is 40 participants, below the 107-participant average among 9 other Osteopenia trials with a reported enrollment target (63% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04233112, a Early Phase 1 study of Osteopenia, is active but no longer recruiting, sponsored by Duquesne University.
- ACTIVE NOT RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 40 participants
- Enrollment target
- 2
- Study locations
Study Summary
This study will be assessing the efficacy of melatonin and/or osteogenic loading on modulating bone health in an osteopenic population.
Primary Outcome
Bone mineral density (BMD) at baseline (month 0) and month 12. Bone density will be assessed by dual energy x-ray absorptiometry (DXA) scan at baseline (month 0) and at month 12. Bone density, expressed as percentage change from baseline (T-scores), will be compared within and between groups at 12 mos.
Conditions Studied
Interventions
- DRUG Melatonin 5 mg
- DEVICE Osteogenic loading
- DEVICE Mock for Osteogenic Loading
- DRUG Placebo (plant fiber) for melatonin
Study Locations (2)
Pennsylvania
- OsteoStrong® in Scott Towne Center - Pittsburgh
- Duquesne University - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2020-05-26 |
| Est. Completion | 2025-09-01 |
| Phase | Early Phase 1 |
What the registry record for NCT04233112 still lists
NCT04233112 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 107-participant average among 9 other Osteopenia trials with a reported enrollment target (63% lower).
The record links to 1 condition, with Osteopenia appearing as the primary indexed condition, and to 4 interventions - of which Melatonin 5 mg is the first listed.
NCT04233112 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT04233112 about?
NCT04233112 is a clinical study titled "Melatonin and Osteogenic Loading on Osteopenia". This study will be assessing the efficacy of melatonin and/or osteogenic loading on modulating bone health in an osteopenic population.
What is the current status of trial NCT04233112?
This trial is currently active not recruiting. It is a Early Phase 1 study. The enrollment target is 40 participants. The study started on 2020-05-26. Estimated completion is 2025-09-01.
What conditions does trial NCT04233112 study?
This clinical trial studies the following conditions: Osteopenia.
What interventions are being tested in trial NCT04233112?
The interventions under investigation include: Melatonin 5 mg (DRUG), Osteogenic loading (DEVICE), Mock for Osteogenic Loading (DEVICE), Placebo (plant fiber) for melatonin (DRUG).
Who is sponsoring clinical trial NCT04233112?
This trial is sponsored by Duquesne University, which has 21 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04233112 being conducted?
This trial has 2 study locations across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Osteopenia
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 NCT04233112's enrollment target sits among peer trials
40 6th of 9 higher than 4 of 9 other Osteopenia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Osteopenia 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.
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