NCT04233112

Melatonin and Osteogenic Loading on Osteopenia

Assessing the Efficacy of Melatonin and Osteogenic Loading on Bone Health in an Osteopenic Population: MelaOstrong Study

• Status: Active Not Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Duquesne University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Osteopenia

Interventions

Type	Name	Description
DRUG	Melatonin 5 mg	Capsules containing 5mg melatonin will be prepared by Delta Care RX™ Pharmacy. Participants will be asked to take them nightly for one year.
DEVICE	Osteogenic loading	Osteogenic loading device therapy includes the emulation of impact forces through kinetic chains of natural impact absorption with fixtures that have the ability to capture bone compression data. Participants will be asked to perform osteogenic loading once per week.
DEVICE	Mock for Osteogenic Loading	Mock osteogenic loading will occur using the osteogenic loading device therapy includes the emulation of impact forces through kinetic chains of natural impact absorption with fixtures that have the ability to capture bone compression data. Participants will be asked to perform mock osteogenic loading once per week.
DRUG	Placebo (plant fiber) for melatonin	Capsules containing plant fiber will be prepared by Delta Care RX™ Pharmacy. Participants will be asked to take them nightly for one year.

Timeline

• Start date: 2020-05-26
• Primary completion: 2024-12-31
• Completion: 2025-09-01
• First posted: 2020-01-18
• Last updated: 2025-08-22

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study