Assessing the Efficacy of Melatonin and Osteogenic Loading on Bone Health in an Osteopenic Population: MelaOstrong Study
Trial Snapshot
- Phase
- Early Phase 1
- Status
- Active, not recruiting
- Sponsor
- Duquesne University
- Enrollment
- 40
- Locations
- 2
- Primary Endpoint
- Bone mineral density
Study Overview
Brief Summary
This study will be assessing the efficacy of melatonin and/or osteogenic loading on modulating bone health in an osteopenic population.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Placebo/Mock
Placebo capsules; mock osteogenic loading
Intervention: Mock for Osteogenic Loading (Device)
Placebo/Mock
Placebo capsules; mock osteogenic loading
Intervention: Placebo (plant fiber) for melatonin (Drug)
Melatonin/Mock
Melatonin capsules; mock osteogenic loading
Intervention: Melatonin 5 mg (Drug)
Melatonin/Mock
Melatonin capsules; mock osteogenic loading
Intervention: Mock for Osteogenic Loading (Device)
Placebo/Osteogenic loading
Placebo capsules/osteogenic loading
Intervention: Osteogenic loading (Device)
Placebo/Osteogenic loading
Placebo capsules/osteogenic loading
Intervention: Placebo (plant fiber) for melatonin (Drug)
Melatonin/Osteogenic loading
Melatonin capsules/osteogenic loading
Intervention: Melatonin 5 mg (Drug)
Melatonin/Osteogenic loading
Melatonin capsules/osteogenic loading
Intervention: Osteogenic loading (Device)
Outcomes
Primary Outcomes
Bone mineral density
Time Frame: O-12 months
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.
Secondary Outcomes
No secondary outcomes reported