OsteopeniaEarly Phase 1MelaOstrongNCT04233112
Melatonin and Osteogenic Loading on Osteopenia
A Early Phase 1 study testing Melatonin 5 mg, Osteogenic loading and Mock for Osteogenic Loading in people with Osteopenia, run by Duquesne University at 2 sites in United States.
Trial summary
This study will be assessing the efficacy of melatonin and/or osteogenic loading on modulating bone health in an osteopenic population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteopenia
- What is being tested?
- Melatonin 5 mg, Osteogenic loading and Mock for Osteogenic Loading
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 2 sitesUnited States
- Study dates
- 2 Jul 2020to 8 Aug 2024
- Phase
- Early Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Inclusion criteria: To be included in the study, the 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. The participant must be willing to undergo an osteogenic loading protocol once per week and/or take a pill (placebo or melatonin) for one year. The participant must also 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). The study participants must also be willing to get a DXA scan at months 0 and 12 at one of the three Weinstein Imaging locations.
Exclusion criteria: Women or men with osteoporosis; women or men with osteopenia due to hyperparathyroidism, multiple myeloma, metastatic bone disease, chronic steroid use including corticosteroids; women or men who are on any bone therapies (i.e. bisphosphonates, selective estrogen receptor modulators (SERMs), hormone therapy, teriparatide, and denosumab); men and women with chronic obstructive pulmonary disease (COPD); women or men who smoke; pregnant women; and men or women with muscular dystrophy, unmedicated hypertension, or unrepaired hernia, restrictions to movement and exercise, and parathyroid dysfunctions.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
OsteoStrong® in Scott Towne Center
Pittsburgh, Pennsylvania, 15220
Duquesne University
Pittsburgh, Pennsylvania, 15282
About this study
Official title: Assessing the Efficacy of Melatonin and Osteogenic Loading on Bone Health in an Osteopenic Population: MelaOstrong Study
This study will be assessing the efficacy of melatonin and/or osteogenic loading on modulating bone health in an osteopenic population.
- Conditions
- Osteopenia
- Being tested
- Melatonin 5 mg, Osteogenic loading, Mock for Osteogenic Loading, Placebo (plant fiber) for melatonin
- Medical subject headings
- Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Melatonin 5 mgDrug
Capsules containing 5mg melatonin will be prepared by Delta Care RX™ Pharmacy. Participants will be asked to take them nightly for one year.
Osteogenic loadingDevice
Osteogenic loading device therapy includes the emulation of impact forces through kinetic chains of natural impact absorption with fixtures that have the ability to capture bone compression data. Participants will be asked to perform osteogenic loading once per week.
Mock for Osteogenic LoadingDevice
Mock osteogenic loading will occur using the osteogenic loading device therapy includes the emulation of impact forces through kinetic chains of natural impact absorption with fixtures that have the ability to capture bone compression data. Participants will be asked to perform mock osteogenic loading once per week.
Placebo (plant fiber) for melatoninDrug
Capsules containing plant fiber will be prepared by Delta Care RX™ Pharmacy. Participants will be asked to take them nightly for one year.
| Study group | Role | What they receive |
|---|---|---|
| Placebo/Mock | Placebo comparator | Placebo capsules; mock osteogenic loading Receives: Device: Mock for Osteogenic Loading; Drug: Placebo (plant fiber) for melatonin |
| Melatonin/Mock | Experimental | Melatonin capsules; mock osteogenic loading Receives: Drug: Melatonin 5 mg; Device: Mock for Osteogenic Loading |
| Placebo/Osteogenic loading | Experimental | Placebo capsules/osteogenic loading Receives: Device: Osteogenic loading; Drug: Placebo (plant fiber) for melatonin |
| Melatonin/Osteogenic loading | Experimental | Melatonin capsules/osteogenic loading Receives: Drug: Melatonin 5 mg; Device: Osteogenic loading |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone Mineral Density Femoral Neck
Bone mineral density was assessed by dual-energy X-ray absorptiometry (DXA). The T-score compares the participant's BMD with a healthy young-adult reference population. A T-score of 0 represents the young-adult reference mean; each 1.0-unit difference represents 1 standard deviation above or below that mean. Higher or less negative T-scores indicate greater BMD or better bone health. Clinical categories are: greater than -1.0 = normal, -1.0 to -2.5 = osteopenia, and less than or equal to -2.5 = osteoporosis. Change was calculated as 12-month T-score minus baseline T-score. A mean femoral neck T-score of -1.7 indicates BMD below the healthy young-adult reference mean and falls within the osteopenic range. The SD of 0.4 indicates that participants' femoral neck T-scores varied around the group mean by approximately 0.4 T-score units.
Measured: 0-12 months
Bone Mineral Density Total Hip
Bone mineral density was assessed by dual-energy X-ray absorptiometry (DXA). The T-score compares the participant's BMD with a healthy young-adult reference population. A T-score of 0 represents the young-adult reference mean; each 1.0-unit difference represents 1 standard deviation above or below that mean. Higher or less negative T-scores indicate greater BMD or better bone health. Clinical categories are: greater than -1.0 = normal, -1.0 to -2.5 = osteopenia, and less than or equal to -2.5 = osteoporosis. Change was calculated as 12-month T-score minus baseline T-score. A mean left hip T-score of -1.2 indicates BMD below the healthy young-adult reference mean and falls within the osteopenic range. The SD of 0.6 indicates that participants' left hip T-scores varied around the group mean by approximately 0.6 T-score units.
Measured: O-12 months
Bone Mineral Density Lumbar Spine
Bone mineral density was assessed by dual-energy X-ray absorptiometry (DXA). The T-score compares the participant's BMD with a healthy young-adult reference population. A T-score of 0 represents the young-adult reference mean; each 1.0-unit difference represents 1 standard deviation above or below that mean. Higher or less negative T-scores indicate greater BMD or better bone health. Clinical categories are: greater than -1.0 = normal, -1.0 to -2.5 = osteopenia, and less than or equal to -2.5 = osteoporosis. Change was calculated as 12-month T-score minus baseline T-score. A mean lumbar spine T-score of -1.4 indicates BMD below the healthy young-adult reference mean and falls within the osteopenic range. The SD of 0.6 indicates that participants' lumbar spine T-scores varied around the group mean by approximately 0.6 T-score units.
Measured: O-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start2 Jul 2020
- Primary completion8 Aug 2024
- Study completion8 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OsteopeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duquesne University
- Sponsor type
- University, hospital or other
- Collaborators
- OsteoStrong
- Responsible party
- Sponsor
- Investigators
- Paula Witt-Enderby, PhD, Principal investigator, Duquesne University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04233112
- Sponsor's protocol ID
- 2019/08/15
- Acronym
- MelaOstrong
- Status last verified
- Apr 2026
- First submitted
- 15 Jan 2020
- Last updated
- 22 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Jahan A, Myoung Y, Malik A, Gionfriddo MR, Witt-Enderby PA. Pilot Study Assessing the Efficacy of Melatonin and Osteogenic Loading on Bone Health in a Postmenopausal Population with Osteopenia: MelaOstrong Randomized Controlled Trial. J Pineal Res. 2025 Nov;77(6):e70088. doi: 10.1111/jpi.70088.
PubMed 41059603