Melatonin and Osteogenic Loading on Osteopenia

Osteopenia Clinical Trial

— MelaOstrong  

Official title:

Assessing the Efficacy of Melatonin and Osteogenic Loading on Bone Health in an Osteopenic Population: MelaOstrong Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04233112
• Other study ID #: 2019/08/15
• Status: Active, not recruiting
• Phase: Early Phase 1
• Start date: May 26, 2020
• Est. completion date: December 31, 2024

Study information

• Verified date: June 2023
• Source: Duquesne University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bone Diseases, Metabolic
• Osteopenia

Intervention

Drug:
• Melatonin 5 mg
Capsules containing 5mg melatonin will be prepared by Delta Care RX™ Pharmacy. Participants will be asked to take them nightly for one year.

Device:
• Osteogenic loading
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 Loading
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.

Drug:
• Placebo (plant fiber) for melatonin
Capsules containing plant fiber will be prepared by Delta Care RX™ Pharmacy. Participants will be asked to take them nightly for one year.

Locations

Country	Name	City	State
United States	Duquesne University	Pittsburgh	Pennsylvania
United States	OsteoStrong® in Scott Towne Center	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Duquesne University	OsteoStrong

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	O-12 months