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Melatonin and Osteogenic Loading on Osteopenia (MelaOstrong)

Primary Purpose

Osteopenia

Status
Active
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Melatonin 5 mg
Osteogenic loading
Mock for Osteogenic Loading
Placebo (plant fiber) for melatonin
Sponsored by
Duquesne University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteopenia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • OsteoStrong® in Scott Towne Center
  • Duquesne University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Arm Label

Placebo/Mock

Melatonin/Mock

Placebo/Osteogenic loading

Melatonin/Osteogenic loading

Arm Description

Placebo capsules; mock osteogenic loading

Melatonin capsules; mock osteogenic loading

Placebo capsules/osteogenic loading

Melatonin capsules/osteogenic loading

Outcomes

Primary Outcome Measures

Bone mineral density
Bone mineral density (BMD) at baseline (month 0) and month 12. Bone density will be assessed by dual energy x-ray absorptiometry (DXA) scan at baseline (month 0) and at month 12. Bone density, expressed as percentage change from baseline (T-scores), will be compared within and between groups at 12 mos.

Secondary Outcome Measures

Full Information

First Posted
January 15, 2020
Last Updated
June 22, 2023
Sponsor
Duquesne University
Collaborators
OsteoStrong
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1. Study Identification

Unique Protocol Identification Number
NCT04233112
Brief Title
Melatonin and Osteogenic Loading on Osteopenia
Acronym
MelaOstrong
Official Title
Assessing the Efficacy of Melatonin and Osteogenic Loading on Bone Health in an Osteopenic Population: MelaOstrong Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 26, 2020 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duquesne University
Collaborators
OsteoStrong

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will be assessing the efficacy of melatonin and/or osteogenic loading on modulating bone health in an osteopenic population.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteopenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo/Mock
Arm Type
Placebo Comparator
Arm Description
Placebo capsules; mock osteogenic loading
Arm Title
Melatonin/Mock
Arm Type
Experimental
Arm Description
Melatonin capsules; mock osteogenic loading
Arm Title
Placebo/Osteogenic loading
Arm Type
Experimental
Arm Description
Placebo capsules/osteogenic loading
Arm Title
Melatonin/Osteogenic loading
Arm Type
Experimental
Arm Description
Melatonin capsules/osteogenic loading
Intervention Type
Drug
Intervention Name(s)
Melatonin 5 mg
Intervention Description
Capsules containing 5mg melatonin will be prepared by Delta Care RX™ Pharmacy. Participants will be asked to take them nightly for one year.
Intervention Type
Device
Intervention Name(s)
Osteogenic loading
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Mock for Osteogenic Loading
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo (plant fiber) for melatonin
Intervention Description
Capsules containing plant fiber will be prepared by Delta Care RX™ Pharmacy. Participants will be asked to take them nightly for one year.
Primary Outcome Measure Information:
Title
Bone mineral density
Description
Bone mineral density (BMD) at baseline (month 0) and month 12. Bone density will be assessed by dual energy x-ray absorptiometry (DXA) scan at baseline (month 0) and at month 12. Bone density, expressed as percentage change from baseline (T-scores), will be compared within and between groups at 12 mos.
Time Frame
O-12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paula Witt-Enderby, PhD
Organizational Affiliation
Duquesne University
Official's Role
Principal Investigator
Facility Information:
Facility Name
OsteoStrong® in Scott Towne Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15220
Country
United States
Facility Name
Duquesne University
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15282
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Melatonin and Osteogenic Loading on Osteopenia

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