Status:
COMPLETED
Melatonin Osteoporosis Prevention Study
Lead Sponsor:
Duquesne University
Conditions:
Osteoporosis
Osteopenia
Eligibility:
FEMALE
45-54 years
Phase:
PHASE1
Brief Summary
Osteoporosis is one of the most common skeletal disorders. Today in the United States, 10 million individuals have osteoporosis and 34 million more have low bone mass or osteopenia, which places them ...
Detailed Description
BACKGROUND AND SIGNIFICANCE Osteoporosis is one of the most common skeletal disorders. Today in the United States, 10 million individuals have osteoporosis and 34 million more have low bone mass or os...
Eligibility Criteria
Inclusion
- Inclusion criteria include perimenopausal women,
- willingness to participate in the 6-month study, willingness to undergo testing of bone turnover markers before and after the drug therapies and willingness to provide a self-assessment on quality of life and sleep throughout the program.
- Subjects must be willing to take their treatments right before bed and to not to consume alcohol with this medication.
Exclusion
- Exclusion criteria will include women in whom osteopenia is a result of some other known process such as hyperparathyroidism, metastatic bone disease, multiple myeloma or chronic steroid use.
- Those individuals on osteoporotic drugs, hypnotics, CYP1A2 inhibiting drugs, fluvoxamine or those with severe sleep apnea, severe COPD and those with moderate or severe hepatic impairment will also be excluded.
- Individuals who are lactose intolerant will also be excluded because the placebo and melatonin capsules will contain lactose.
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT01152580
Start Date
September 1 2008
End Date
July 1 2010
Last Update
March 13 2012
Active Locations (1)
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1
Duquesne University School of Pharmacy Center for Pharmacy Care
Pittsburgh, Pennsylvania, United States, 15282