Melatonin and Osteogenic Loading on Osteopenia

Early Phase 1

Active, not recruiting

• Conditions: Osteopenia
• Interventions: Drug: Melatonin 5 mg; Device: Mock for Osteogenic Loading; Device: Osteogenic loading; Drug: Placebo (plant fiber) for melatonin

• Registration Number: NCT04233112
• Lead Sponsor: Duquesne University

Brief Summary

This study will be assessing the efficacy of melatonin and/or osteogenic loading on modulating bone health in an osteopenic population.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-01-15
• Study First Submitted QC: 2020-01-15
• Study First Posted: 2020-01-18
• Study Start: 2020-05-26
• Primary Completion: 2024-12-31
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-04
• Last Update Posted: 2025-02-06
• Study Completion: 2025-05-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Melatonin/Mock	Melatonin 5 mg	Melatonin capsules; mock osteogenic loading
Placebo/Osteogenic loading	Placebo (plant fiber) for melatonin	Placebo capsules/osteogenic loading
Placebo/Mock	Mock for Osteogenic Loading	Placebo capsules; mock osteogenic loading
Placebo/Mock	Placebo (plant fiber) for melatonin	Placebo capsules; mock osteogenic loading
Melatonin/Osteogenic loading	Melatonin 5 mg	Melatonin capsules/osteogenic loading
Melatonin/Mock	Mock for Osteogenic Loading	Melatonin capsules; mock osteogenic loading
Placebo/Osteogenic loading	Osteogenic loading	Placebo capsules/osteogenic loading
Melatonin/Osteogenic loading	Osteogenic loading	Melatonin capsules/osteogenic loading

Primary Outcome Measures

Name	Time	Method
Bone mineral density	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.

Trial Locations

Locations (2)

Duquesne University; 🇺🇸 Pittsburgh, Pennsylvania, United States

OsteoStrong® in Scott Towne Center; 🇺🇸 Pittsburgh, Pennsylvania, United States