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ACTIVE NOT RECRUITING
NCT04233112
EARLY_PHASE1

Melatonin and Osteogenic Loading on Osteopenia

Sponsor: Duquesne University

View on ClinicalTrials.gov

Summary

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

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2020-05-26

Completion Date

2025-09-01

Last Updated

2025-08-22

Healthy Volunteers

No

Conditions

Interventions

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.

Locations (2)

OsteoStrong® in Scott Towne Center

Pittsburgh, Pennsylvania, United States

Duquesne University

Pittsburgh, Pennsylvania, United States