Osteopenia
Conditions
Brief summary
This study will be assessing the efficacy of melatonin and/or osteogenic loading on modulating bone health in an osteopenic population.
Interventions
DRUGMelatonin 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.
DEVICEOsteogenic 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.
DEVICEMock 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.
DRUGPlacebo (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.
Sponsors
Duquesne University
OsteoStrong
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bone Mineral Density Femoral Neck | 0-12 months | Bone mineral density was assessed by dual-energy X-ray absorptiometry (DXA). The T-score compares the participant's BMD with a healthy young-adult reference population. A T-score of 0 represents the young-adult reference mean; each 1.0-unit difference represents 1 standard deviation above or below that mean. Higher or less negative T-scores indicate greater BMD or better bone health. Clinical categories are: greater than -1.0 = normal, -1.0 to -2.5 = osteopenia, and less than or equal to -2.5 = osteoporosis. Change was calculated as 12-month T-score minus baseline T-score. A mean femoral neck T-score of -1.7 indicates BMD below the healthy young-adult reference mean and falls within the osteopenic range. The SD of 0.4 indicates that participants' femoral neck T-scores varied around the group mean by approximately 0.4 T-score units. |
| Bone Mineral Density Total Hip | O-12 months | Bone mineral density was assessed by dual-energy X-ray absorptiometry (DXA). The T-score compares the participant's BMD with a healthy young-adult reference population. A T-score of 0 represents the young-adult reference mean; each 1.0-unit difference represents 1 standard deviation above or below that mean. Higher or less negative T-scores indicate greater BMD or better bone health. Clinical categories are: greater than -1.0 = normal, -1.0 to -2.5 = osteopenia, and less than or equal to -2.5 = osteoporosis. Change was calculated as 12-month T-score minus baseline T-score. A mean left hip T-score of -1.2 indicates BMD below the healthy young-adult reference mean and falls within the osteopenic range. The SD of 0.6 indicates that participants' left hip T-scores varied around the group mean by approximately 0.6 T-score units. |
| Bone Mineral Density Lumbar Spine | O-12 months | Bone mineral density was assessed by dual-energy X-ray absorptiometry (DXA). The T-score compares the participant's BMD with a healthy young-adult reference population. A T-score of 0 represents the young-adult reference mean; each 1.0-unit difference represents 1 standard deviation above or below that mean. Higher or less negative T-scores indicate greater BMD or better bone health. Clinical categories are: greater than -1.0 = normal, -1.0 to -2.5 = osteopenia, and less than or equal to -2.5 = osteoporosis. Change was calculated as 12-month T-score minus baseline T-score. A mean lumbar spine T-score of -1.4 indicates BMD below the healthy young-adult reference mean and falls within the osteopenic range. The SD of 0.6 indicates that participants' lumbar spine T-scores varied around the group mean by approximately 0.6 T-score units. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORPaula Witt-Enderby, PhD
Duquesne University
Participant flow
Pre-assignment details
Participants were excluded and not randomized if osteoporosis was detected based on our DXA screening.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 18 Participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 5 | 0 / 4 | 0 / 6 | 0 / 4 |
| other Total, other adverse events | 0 / 5 | 0 / 4 | 0 / 6 | 0 / 4 |
| serious Total, serious adverse events | 0 / 5 | 0 / 4 | 0 / 6 | 0 / 4 |
Outcome results
None listed