Melatonin + Osteogenic Loading for Osteopenia

(MelaOstrong Trial)

Recruiting at 1 trial location

Overseen By Paula Witt-Enderby, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Waitlist Available

Sponsor: Duquesne University

Trial Summary

What is the purpose of this trial?

This trial is testing if melatonin and/or special exercises can improve bone health in people with low bone density. Melatonin may help bone cells grow, and the exercises make bones stronger. Melatonin has been shown to improve bone mineral density and promote bone formation in various studies.

Research Team

Paula Witt-Enderby, PhD

Principal Investigator

Duquesne University

Eligibility Criteria

This trial is for men and women at least 18 years old with osteopenia, a condition where bone density is lower than normal but not low enough to be classified as osteoporosis. Participants must agree to weekly osteogenic loading exercises, take a daily pill (melatonin or placebo), have scans at specified locations, and attend study visits for blood pressure checks and questionnaires.

Inclusion Criteria

I am willing to follow a weekly bone-strengthening routine and take a daily pill for a year.

Study participants must also be willing to get a DXA scan at months 0 and 12 at one of the three Weinstein Imaging locations

Participant must 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)

Exclusion Criteria

I have osteoporosis.

I am currently taking medication for bone health.

I have muscular dystrophy, high blood pressure without medication, an unrepaired hernia, movement restrictions, or parathyroid issues.

Treatment Details

Interventions

• Melatonin (Hormone Therapy)
• Osteogenic Loading (Procedure)

Trial Overview The study tests if melatonin supplements and/or osteogenic loading exercises can improve bone health in people with osteopenia. Participants will either do the exercise, take melatonin, both, or receive mock treatments (placebo) over one year.

Participant Groups

Group I: Placebo/Osteogenic loading Experimental Treatment 2 Interventions

Placebo capsules/osteogenic loading

Group II: Melatonin/Osteogenic loading Experimental Treatment 2 Interventions

Melatonin capsules/osteogenic loading

Group III: Melatonin/Mock Experimental Treatment 2 Interventions

Melatonin capsules; mock osteogenic loading

Group IV: Placebo/Mock Placebo Group 2 Interventions

Placebo capsules; mock osteogenic loading

Who Is Running the Clinical Trial?

Duquesne University

Lead Sponsor

Trials

33

Recruited

2,500+

OsteoStrong

Collaborator

Trials

1

Recruited

40+