Melatonin + Osteogenic Loading for Osteopenia

(MelaOstrong Trial)

Recruiting at 1 trial location

Overseen By Paula Witt-Enderby, PhD

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Duquesne University

Must not be taking: Bone therapies

Disqualifiers: Osteoporosis, Hyperparathyroidism, COPD, others

Compensation: Varies

Number of Visits: 12

Duration: 12 months

40 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires that you are not on any bone therapies like bisphosphonates, SERMs, hormone therapy, teriparatide, or denosumab. If you are taking these, you would need to stop before participating.

What data supports the effectiveness of the drug Melatonin for treating osteopenia?

Research shows that melatonin can improve bone mineral density in postmenopausal women with osteopenia, suggesting it may help strengthen bones. Additionally, melatonin has been found to promote new bone formation and suppress bone loss, making it a promising option for bone health. ^{1 2 3 4 5}

How does the treatment of Melatonin + Osteogenic Loading for osteopenia differ from other treatments?

This treatment is unique because it combines melatonin, which not only helps regulate sleep but also promotes bone formation and reduces bone loss, with osteogenic loading, a physical therapy that strengthens bones through weight-bearing exercises. Unlike conventional treatments that mainly focus on preventing bone loss, this approach aims to both preserve and enhance bone density. ^{1 2 3 4 5}

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive melatonin and/or osteogenic loading interventions

12 months

DXA scans at baseline and month 12

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Melatonin
• Osteogenic Loading

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

Melatonin is already approved in European Union, United States for the following indications:

Approved in European Union as Circadin for:

• Insomnia in adults aged 55 and over
• Sleep disorders in children with autism spectrum disorder

Approved in European Union as Slenyto for:

• Insomnia in children and adolescents aged 2-18 with autism spectrum disorder

Approved in United States as Melatonin for:

• Sleep disorders in children with autism spectrum disorder
• Insomnia in adults

Who Is Running the Clinical Trial?

Duquesne University

Lead Sponsor

Trials

33

Recruited

2,500+

OsteoStrong

Collaborator

Trials

1

Recruited

40+

References

1. England pubmed.ncbi.nlm.nih.gov

Effects on bone by the light/dark cycle and chronic treatment with melatonin and/or hormone replacement therapy in intact female mice. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Melatonin: Another avenue for treating osteoporosis? [2019]

3. England pubmed.ncbi.nlm.nih.gov

Regulation of bone mass through pineal-derived melatonin-MT2 receptor pathway. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Novel bromomelatonin derivatives as potentially effective drugs to treat bone diseases. [2013]

5. England pubmed.ncbi.nlm.nih.gov

Melatonin improves bone mineral density at the femoral neck in postmenopausal women with osteopenia: a randomized controlled trial. [2022]