Melatonin and Osteogenic Loading on Osteopenia

EARLY_PHASE1Active, not recruitingINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

May 26, 2020

Primary Completion Date

December 31, 2024

Study Completion Date

September 1, 2025

Conditions
Osteopenia
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.

Trial Locations (2)

15220

OsteoStrong® in Scott Towne Center, Pittsburgh

15282

Duquesne University, Pittsburgh

All Listed Sponsors
collaborator

OsteoStrong

UNKNOWN

lead

Duquesne University

OTHER