Melatonin and Osteogenic Loading on Osteopenia

NCT ID: NCT04233112

Last Updated: 2025-08-22

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-26
• Study Completion Date: 2025-09-01

Brief Summary

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

Conditions

Osteopenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo/Mock

Placebo capsules; mock osteogenic loading

Group Type: PLACEBO_COMPARATOR

Mock for Osteogenic Loading

Intervention Type: DEVICE

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 melatonin

Intervention Type: DRUG

Capsules containing plant fiber will be prepared by Delta Care RX™ Pharmacy. Participants will be asked to take them nightly for one year.

Melatonin/Mock

Melatonin capsules; mock osteogenic loading

Group Type: EXPERIMENTAL

Melatonin 5 mg

Intervention Type: DRUG

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

Mock for Osteogenic Loading

Intervention Type: DEVICE

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/Osteogenic loading

Placebo capsules/osteogenic loading

Group Type: EXPERIMENTAL

Osteogenic loading

Intervention Type: DEVICE

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.

Placebo (plant fiber) for melatonin

Intervention Type: DRUG

Capsules containing plant fiber will be prepared by Delta Care RX™ Pharmacy. Participants will be asked to take them nightly for one year.

Melatonin/Osteogenic loading

Melatonin capsules/osteogenic loading

Group Type: EXPERIMENTAL

Melatonin 5 mg

Intervention Type: DRUG

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

Osteogenic loading

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: DEVICE

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.

Intervention Type: DEVICE

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

OsteoStrong

UNKNOWN

Sponsor Role: collaborator

Duquesne University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paula Witt-Enderby, PhD

Role: PRINCIPAL_INVESTIGATOR

Duquesne University

Locations

OsteoStrong® in Scott Towne Center

Pittsburgh, Pennsylvania, United States

Duquesne University

Pittsburgh, Pennsylvania, United States

Countries

United States

Other Identifiers

2019/08/15

Identifier Type: -

Identifier Source: org_study_id