← Back to Search

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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up o-12 months
Awards & highlights

MelaOstrong Trial Summary

This trial will test if melatonin and/or osteogenic loading can improve bone health in people with osteopenia.

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.Check my eligibility
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.See study design
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.

MelaOstrong Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 or older with a diagnosis of osteopenia.

MelaOstrong Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Bone mineral density

MelaOstrong 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
~250

Find a Location

Who is running the clinical trial?

Duquesne UniversityLead Sponsor
30 Previous Clinical Trials
2,388 Total Patients Enrolled
OsteoStrongUNKNOWN
Paula Witt-Enderby, PhDPrincipal InvestigatorDuquesne University

Media Library

Melatonin (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04233112 — Phase < 1
Osteopenia Research Study Groups: Placebo/Mock, Melatonin/Mock, Placebo/Osteogenic loading, Melatonin/Osteogenic loading
Osteopenia Clinical Trial 2023: Melatonin Highlights & Side Effects. Trial Name: NCT04233112 — Phase < 1
Melatonin (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04233112 — Phase < 1
Osteopenia Patient Testimony for trial: Trial Name: NCT04233112 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are currently involved in this research?

"Affirmative. Clinicaltrials.gov reveals that this trial, initially posted on May 26th 2020 and last revised on March 21st 2022, is currently looking for volunteers. The protocol requires 40 individuals to sign up at two separate medical establishments."

Answered by AI

Is enrollment open for this particular research initiative?

"The latest information posted on clinicaltrials.gov affirms that this medical experiment commenced recruitment on May 26th 2020, and is still seeking participants as of March 21st 2022."

Answered by AI

Could you please provide a synopsis of other Osteogenic loading experiments which have been conducted?

"Currently, 24 clinical trials are in progress examining the effects and potential of Osteogenic loading. Of those active studies, 4 have reached Phase 3. Most of these experiments take place within Houston, Texas though there are 25 total sites running such tests."

Answered by AI

Is this an unprecedented clinical investigation?

"Presently, 24 active trials for Osteogenic loading are occurring across 12 cities and 9 nations. The initial trial of this type was funded by Eli Lilly and Company in 2007, with 20 research subjects involved. Since then, 125 clinical tests have been concluded."

Answered by AI

Who else is applying?

What state do they live in?
Maryland
What site did they apply to?
OsteoStrong® in Scott Towne Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
1

Why did patients apply to this trial?

To see if anything you do can help with my condition.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Melatonin and Osteogenic Loading on Osteopenia
2020. "Melatonin and Osteogenic Loading on Osteopenia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04233112.
All > Osteopenia > Melatonin
~6 spots leftby Dec 2024
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top