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Hormone Therapy
Melatonin + Osteogenic Loading for Osteopenia (MelaOstrong Trial)
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
Awards & highlights
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 belowSelect...
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:Select...
I have osteoporosis.
Select...
I am currently taking medication for bone health.
Select...
I have weak bones due to a specific health condition or long-term steroid use.
Select...
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
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
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.
Melatonin improves bone mineral density at the femoral neck in postmenopausal women with osteopenia: a randomized controlled trial.
Find a Location
Who is running the clinical trial?
Duquesne UniversityLead Sponsor
31 Previous Clinical Trials
2,444 Total Patients Enrolled
OsteoStrongUNKNOWN
Paula Witt-Enderby, PhDPrincipal InvestigatorDuquesne University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am willing to follow a weekly bone-strengthening routine and take a daily pill for a year.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.I have weak bones due to a specific health condition or long-term steroid use.I have chronic obstructive pulmonary disease (COPD).I am a smoker.I am 18 or older with a diagnosis of osteopenia.I am willing to follow a weekly bone-strengthening routine and take a daily pill for a year.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo/Mock
- Group 2: Melatonin/Mock
- Group 3: Placebo/Osteogenic loading
- Group 4: Melatonin/Osteogenic loading
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Osteopenia Patient Testimony for trial: Trial Name: NCT04233112 — Phase < 1
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