Clinical Trials/NCT04233112

NCT04233112

Active, not recruiting

Early Phase 1

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

Duquesne University2 sites in 1 country40 target enrollmentMay 26, 2020

ConditionsOsteopenia

InterventionsMock for Osteogenic Loading Placebo (plant fiber) for melatonin Melatonin 5 mg Osteogenic loading

Overview

Phase: Early Phase 1
Intervention: Mock for Osteogenic Loading
Conditions: Osteopenia
Sponsor: Duquesne University
Enrollment: 40
Locations: 2
Primary Endpoint: Bone mineral density
Status: Active, not recruiting
Last Updated: 8 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

May 26, 2020

End Date

September 1, 2025

Last Updated

8 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Duquesne University

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arms & Interventions

Placebo/Mock

Placebo capsules; mock osteogenic loading

Intervention: Mock for Osteogenic Loading

Placebo/Mock

Placebo capsules; mock osteogenic loading

Intervention: Placebo (plant fiber) for melatonin

Melatonin/Mock

Melatonin capsules; mock osteogenic loading

Intervention: Melatonin 5 mg

Melatonin/Mock

Melatonin capsules; mock osteogenic loading

Intervention: Mock for Osteogenic Loading

Placebo/Osteogenic loading

Placebo capsules/osteogenic loading

Intervention: Osteogenic loading

Placebo/Osteogenic loading

Placebo capsules/osteogenic loading

Intervention: Placebo (plant fiber) for melatonin

Melatonin/Osteogenic loading

Melatonin capsules/osteogenic loading

Intervention: Melatonin 5 mg

Melatonin/Osteogenic loading

Melatonin capsules/osteogenic loading

Intervention: Osteogenic loading

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.