Melatonin Osteoporosis Prevention Study

Completed · Phase 1

Conditions studied: Osteoporosis, Osteopenia

In brief

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 at an increased risk of some day developing osteoporosis. Of the people affected by this problem, 68% are women.The current thinking on the development of osteoporosis is that the changes in bone turnover that occur with aging play a major factor. Many modalities of treatment are used to prevent the bone loss and increased fracture risk associated with osteoporosis and osteopenia. Melatonin supplementation may be another treatment modality that lowers risk of hip fracture in perimenopausal women. Melatonin can remodel bone in animal models and in culture. Melatonin works through melatonin receptors to form osteoblasts from human mesenchymal stem cells and has been shown to inhibit osteoclast activity in rodents. Melatonin levels have been correlated with modulating bone markers; low nocturnal levels of melatonin correlate with in an increase in bone marker metabolism and osteoporosis. It is been shown that women who have worked night-shifts for greater than 20 years have increased risk for wrist and hip fractures. Night-shift workers have lower nocturnal melatonin levels than people who do not work the night-shift. The addition of exogenous melatonin suppresses bone marker metabolism. In human stem cells taken from bone marrow, melatonin increases the activity of bone-forming cells called osteoblasts. It is hypothesized that melatonin will improve bone health, menopausal quality of life and sleep compared to placebo in perimenopausal women. In particular, the investigators expect perimenopausal women taking melatonin to show an improvement in overall bone health as revealed by a reduction in bone marker turnover since bone resorption increases more so than bone absorption in this population compared to those women taking placebo. We also expect that perimenopausal women taking melatonin to have better control over their menopausal symptoms, better quality of life and less sleep disturbances when compared to their placebo controls since melatonin is known to modulate estrogen levels in the body and regulate sleep. The data from these studies may provide novel and alternative uses for melatonin; in particular its use for the prevention and/or treatment of osteoporosis.

Key facts

Study ID

NCT01152580

Run by

Duquesne University

People needed

19

Starts

2008-09-01

Expected to finish

2010-07-01

Last updated by the study team

2012-03-13

Who can join

Age: 45 and older, up to 54. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Duquesne University School of Pharmacy Center for Pharmacy Care — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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