Status:
COMPLETED
Melatonin-Micronutrients for Osteopenia Treatment Study
Lead Sponsor:
Duquesne University
Conditions:
Osteoporosis
Osteopenia
Eligibility:
FEMALE
Phase:
PHASE1
Brief Summary
The investigators' long-term goal is to employ novel methods to improve bone formation and bone density in women (and men) with osteopenia or osteoporosis while also decreasing signs and symptoms of d...
Eligibility Criteria
Inclusion
- postmenopausal
- must be osteopenic (T-score between -2.5 and -1)
- willingness to participate in the 12-month study
- willingness to undergo testing of bone turnover markers before and after the drug therapies
- willingness to provide a self-assessment on quality of life throughout the program
- willingness to take their treatments right before bed
- willingness to not to consume alcohol with this medication
Exclusion
- women in whom osteopenia is a result of some other known process (e.g. hyperparathyroidism, metastatic bone disease, multiple myeloma or chronic steroid use).
- women on osteoporotic drugs, hypnotics, CYP1A2 inhibiting drugs, fluvoxamine
- women with severe sleep apnea, severe COPD and those with moderate or severe hepatic or renal impairment.
Key Trial Info
Start Date :
August 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 9 2017
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT01870115
Start Date
August 1 2013
End Date
February 9 2017
Last Update
June 14 2018
Active Locations (1)
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1
Duquesne University Center for Pharmacy Care
Pittsburgh, Pennsylvania, United States, 15282