Melatonin and Osteogenic Loading on Osteopenia (MelaOstrong)
Osteopenia
About this trial
This is an interventional treatment trial for Osteopenia
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.
Sites / Locations
- OsteoStrong® in Scott Towne Center
- Duquesne University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Placebo Comparator
Experimental
Experimental
Experimental
Placebo/Mock
Melatonin/Mock
Placebo/Osteogenic loading
Melatonin/Osteogenic loading
Placebo capsules; mock osteogenic loading
Melatonin capsules; mock osteogenic loading
Placebo capsules/osteogenic loading
Melatonin capsules/osteogenic loading