NCT04233112

Brief Summary

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P50-P75 for early_phase_1

Timeline
Completed

Started May 2020

Longer than P75 for early_phase_1

Geographic Reach
1 country

2 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 15, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 18, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

May 26, 2020

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

August 22, 2025

Status Verified

August 1, 2025

Enrollment Period

4.6 years

First QC Date

January 15, 2020

Last Update Submit

August 18, 2025

Conditions

Osteopenia

Outcome Measures

Primary Outcomes (1)

  • Bone mineral density

    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.

    O-12 months

Study Arms (4)

Placebo/Mock

PLACEBO COMPARATOR

Placebo capsules; mock osteogenic loading

Device: Mock for Osteogenic LoadingDrug: Placebo (plant fiber) for melatonin

Melatonin/Mock

EXPERIMENTAL

Melatonin capsules; mock osteogenic loading

Drug: Melatonin 5 mgDevice: Mock for Osteogenic Loading

Placebo/Osteogenic loading

EXPERIMENTAL

Placebo capsules/osteogenic loading

Device: Osteogenic loadingDrug: Placebo (plant fiber) for melatonin

Melatonin/Osteogenic loading

EXPERIMENTAL

Melatonin capsules/osteogenic loading

Drug: Melatonin 5 mgDevice: Osteogenic loading

Interventions

Melatonin 5 mgDRUG

Capsules containing 5mg melatonin will be prepared by Delta Care RX™ Pharmacy. Participants will be asked to take them nightly for one year.

Melatonin/MockMelatonin/Osteogenic loading
Osteogenic loadingDEVICE

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.

Melatonin/Osteogenic loadingPlacebo/Osteogenic loading
Mock for Osteogenic LoadingDEVICE

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.

Melatonin/MockPlacebo/Mock
Placebo (plant fiber) for melatoninDRUG

Capsules containing plant fiber will be prepared by Delta Care RX™ Pharmacy. Participants will be asked to take them nightly for one year.

Placebo/MockPlacebo/Osteogenic loading

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

OsteoStrong® in Scott Towne Center

Pittsburgh, Pennsylvania, 15220, United States

Location

Duquesne University

Pittsburgh, Pennsylvania, 15282, United States

Location

MeSH Terms

Conditions

Bone Diseases, Metabolic

Interventions

MelatoninDietary Fiber

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

TryptaminesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsHormonesHormones, Hormone Substitutes, and Hormone AntagonistsDietary CarbohydratesCarbohydratesFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Paula Witt-Enderby, PhD

    Duquesne University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 15, 2020

First Posted

January 18, 2020

Study Start

May 26, 2020

Primary Completion

December 31, 2024

Study Completion

September 1, 2025

Last Updated

August 22, 2025

Record last verified: 2025-08

Locations

US(2)