Melatonin + Osteogenic Loading for Osteopenia

(MelaOstrong Trial)

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effects of melatonin and a special exercise called osteogenic loading on bone health in individuals with osteopenia, a condition where bones are weaker than normal but not as severe as osteoporosis. The trial includes four groups: one with a placebo, one with melatonin (a hormone supplement), one with osteogenic loading, and one with both melatonin and osteogenic loading. This study suits adults diagnosed with osteopenia who are willing to take capsules and perform weekly osteogenic loading exercises. Participants must also visit the study location for check-ups and provide samples throughout the year. As an Early Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants a chance to contribute to groundbreaking research on bone health.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that melatonin is generally safe for use, with no serious side effects reported. However, some studies mention minor side effects such as dizziness or drowsiness.

Osteogenic loading, an exercise to strengthen bones, is also considered safe. Most research has found no negative effects from this exercise.

Combining melatonin with osteogenic loading has been studied for improving bone health. While specific safety information on using them together is limited, both are individually safe. Consulting a healthcare provider before starting any new treatment is always advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard treatments for osteopenia, which often include medications like bisphosphonates or hormone-related therapies, the combination of melatonin and osteogenic loading offers a fresh approach. Melatonin is not only a sleep aid but also has properties that may promote bone health by enhancing bone formation and reducing resorption. Osteogenic loading, on the other hand, is a physical intervention that applies mechanical stress to bones, potentially leading to increased bone density. Researchers are excited about this combination because it targets bone health through a dual approach: biochemical support with melatonin and mechanical stimulation with osteogenic loading, which could provide a more holistic and potentially more effective way to manage osteopenia.

What evidence suggests that this trial's treatments could be effective for osteopenia?

This trial will evaluate the effects of melatonin and osteogenic loading, both separately and in combination, on bone health. Studies have shown that melatonin can improve bone health. In postmenopausal women with low bone density, taking melatonin for a year increased bone strength by 3.5%. Research also suggests that melatonin supports bone renewal by aiding the process of bone turnover.

Exercises designed to strengthen bones, known as osteogenic loading, have also shown promise. Some studies found these exercises can improve bone strength, especially in the lower back, although results vary. This trial will test whether combining melatonin with these exercises might enhance their effects, offering a potential new way to support bone health in those with low bone density. ^{1 2 3 4 6}

Who Is on the Research Team?

Paula Witt-Enderby, PhD

Principal Investigator

Duquesne University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12127785/

Melatonin: A Potential Therapy for Osteoporosis With Insights ...

In postmenopausal women with osteopenia, a combination of melatonin (5 mg), strontium citrate, vitamin D3, and vitamin K2 improved BMD, bone ...

2.

onlinelibrary.wiley.com

onlinelibrary.wiley.com/doi/10.1111/jpi.70088

Pilot Study Assessing the Efficacy of Melatonin and ...

Our findings align with the MelaOst trial, postmenopausal osteopenic women taking melatonin (3 mg) for 1 year demonstrated 3.5% increases in ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC5310667/

a translational study assessing melatonin, strontium ( ...

Melatonin is a chronotherapeutic hormone and nutritional supplement that has demonstrated efficacy to renormalize bone marker turnover in perimenopausal women [ ...

4.

clinicaltrials.gov

clinicaltrials.gov/study/NCT01152580

NCT01152580 | Melatonin Osteoporosis Prevention Study

We also expect that perimenopausal women taking melatonin to have better control over their menopausal symptoms, better quality of life and less sleep ...

5.

onlinelibrary.wiley.com

onlinelibrary.wiley.com/doi/abs/10.1111/jpi.70088

Pilot Study Assessing the Efficacy of Melatonin and ...

Over 12mos, compared to baseline, participants in the OL/Melatonin group had statistically significant increases in lumbar spine T-scores (mean ...

6.

sciencedirect.com

sciencedirect.com/science/article/pii/S2589537023002602

The short-term and long-term adverse effects of melatonin ...

Melatonin was not associated with serious adverse events, yet the number of patients experiencing non-serious adverse events was increased (Relative risk 1.56, ...