Melatonin and Osteogenic Loading on Osteopenia (MelaOstrong)

Duquesne University

Status and phase: Active, not recruiting; Early Phase 1

Conditions: Osteopenia

Treatments: Device: Osteogenic loading; Drug: Placebo (plant fiber) for melatonin; Device: Mock for Osteogenic Loading; Drug: Melatonin 5 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT04233112

2019/08/15

Details and patient eligibility

About

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

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

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40 participants in 4 patient groups, including a placebo group

Placebo/Mock

Placebo Comparator group

Description:

Placebo capsules; mock osteogenic loading

Treatment:

Device: Mock for Osteogenic Loading

Drug: Placebo (plant fiber) for melatonin

Melatonin/Mock

Experimental group

Description:

Melatonin capsules; mock osteogenic loading

Treatment:

Device: Mock for Osteogenic Loading

Drug: Melatonin 5 mg

Placebo/Osteogenic loading

Experimental group

Description:

Placebo capsules/osteogenic loading

Treatment:

Drug: Placebo (plant fiber) for melatonin

Device: Osteogenic loading

Melatonin/Osteogenic loading

Experimental group

Description:

Melatonin capsules/osteogenic loading

Treatment:

Drug: Melatonin 5 mg

Device: Osteogenic loading