What side effects are associated with this type of intervention?

Common treatments for osteopenia include bisphosphonates, calcium and vitamin D supplementation, and investigational therapies like melatonin and osteogenic loading. Bisphosphonates can cause gastrointestinal issues, musculoskeletal pain, and rarely, osteonecrosis of the jaw. Calcium and vitamin D are generally safe but can lead to hypercalcemia if overused. Melatonin is typically well-tolerated but may cause drowsiness and hormonal changes. Osteogenic loading, a physical therapy, has minimal side effects, mainly related to the mechanical stress applied to bones.

What prior FDA approvals exist?

The FDA has approved several treatments for osteopenia that focus on bone metabolism regulation and mechanical stimulation. Bisphosphonates, such as alendronate and risedronate, are commonly used to prevent bone loss by inhibiting bone resorption. Teriparatide, an anabolic agent, stimulates bone formation and is used in severe cases. While melatonin and osteogenic loading are not specifically mentioned as FDA-approved treatments, their mechanisms—regulating bone metabolism and mechanical stress—are conceptually similar to these approved therapies.

What other types of research exist?

Promising novel alternatives for osteopenia treatment include bisphosphonate therapy, which has been shown to reduce fracture rates and maintain bone turnover markers below pretreatment values. Additionally, C-type natriuretic peptide (CNP) analogues, such as vosoritide, have shown potential in regulating endochondral ossification and improving bone growth. These therapies offer new avenues for managing osteopenia by targeting bone metabolism and formation through different mechanisms.

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Hormone Therapy

Melatonin + Osteogenic Loading for Osteopenia (MelaOstrong Trial)

Q: What is the mechanism of action of this treatment?

Melatonin regulates bone metabolism by enhancing osteoblast activity and reducing osteoclast activity, which helps improve bone mineral density (BMD) and overall bone strength. Osteogenic loading stimulates bone formation through mechanical stress, promoting the deposition of new bone material and increasing BMD. These mechanisms are crucial for osteopenia patients as they directly counteract bone loss and enhance skeletal integrity, thereby reducing the risk of progression to osteoporosis and fractures.

Phase < 1

Waitlist Available

Led By Paula Witt-Enderby, PhD

Research Sponsored by Duquesne University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Be older than 18 years old

Must not have

Women or men with osteoporosis

Women or men who are on any bone therapies (i.e. bisphosphonates, selective estrogen receptor modulators (SERMs), hormone therapy, teriparatide, and denosumab)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up o-12 months

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Melatonin may cause drowsiness, dizziness, headaches or nausea. Osteogenic loading could potentially lead to muscle soreness or joint pain due to the physical nature of the exercises.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 or older with a diagnosis of osteopenia.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have osteoporosis.

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I am currently taking medication for bone health.

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I have weak bones due to a specific health condition or long-term steroid use.

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I am a smoker.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ o-12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~o-12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and o-12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Bone mineral density

Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: Placebo/Osteogenic loadingExperimental Treatment2 Interventions

Placebo capsules/osteogenic loading

Group II: Melatonin/Osteogenic loadingExperimental Treatment2 Interventions

Melatonin capsules/osteogenic loading

Group III: Melatonin/MockExperimental Treatment2 Interventions

Melatonin capsules; mock osteogenic loading

Group IV: Placebo/MockPlacebo Group2 Interventions

Placebo capsules; mock osteogenic loading

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Melatonin 5 mg

2016

Completed Phase 4

~500

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Melatonin regulates bone metabolism by enhancing osteoblast activity and reducing osteoclast activity, which helps improve bone mineral density (BMD) and overall bone strength. Osteogenic loading stimulates bone formation through mechanical stress, promoting the deposition of new bone material and increasing BMD. These mechanisms are crucial for osteopenia patients as they directly counteract bone loss and enhance skeletal integrity, thereby reducing the risk of progression to osteoporosis and fractures.

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