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OpenTrials
Active, Not Recruiting

NCT Number: NCT04233112

Melatonin and Osteogenic Loading on Osteopenia

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Duquesne University, Pittsburgh, Pennsylvania, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

To be included in the study, the participant must be a male or female with osteopenia (T-score between -1.0 and -2.5) who is at least 18 years of age. The participant must be willing to undergo an osteogenic loading protocol once per week and/or take a pill (placebo or melatonin) for one year. The participant must also be willing to come to the study location to receive their monthly capsules and to provide urine, have their blood pressure taken and complete questionnaires on 3 occasions (baseline/month 0, month 3 and month 12). The study participants must also be willing to get a DXA scan at months 0 and 12 at one of the three Weinstein Imaging locations.

Exclusion criteria

Women or men with osteoporosis; women or men with osteopenia due to hyperparathyroidism, multiple myeloma, metastatic bone disease, chronic steroid use including corticosteroids; women or men who are on any bone therapies (i.e. bisphosphonates, selective estrogen receptor modulators (SERMs), hormone therapy, teriparatide, and denosumab); men and women with chronic obstructive pulmonary disease (COPD); women or men who smoke; pregnant women; and men or women with muscular dystrophy, unmedicated hypertension, or unrepaired hernia, restrictions to movement and exercise, and parathyroid dysfunctions.

Treatment and study plan

Melatonin 5 mg

Drug

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

Osteogenic loading

Device

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.

Mock for Osteogenic Loading

Device

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.

Placebo (plant fiber) for melatonin

Drug

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

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Duquesne University

Other

Collaborators

  • OsteoStrong

Registry information

Official study title

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

Acronym: MelaOstrong

Important dates

Study start
2020
Primary completion
2024
Study completion
2025
First posted
Jan 18, 2020
Registry last updated
Aug 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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