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The hormone melatonin has been touted to benefit everything
from jet lag to insomnia to depression. A one-year, $20,000 School of Pharmacy Translational Research Program grant is allowing a team of Duquesne professors and a Magee-Womens Hospital physician to explore whether melatonin can prevent bone loss in perimenopausal women, who are at-risk for osteoporosis.
A person’s bones constantly break down and reform bone to adjust to one’s lifestyle. Problems arise for women when they start going through menopause because their bones break down more than they form due to the loss of estrogen, according to
Dr. Paula Witt-Enderby, professor of pharmacology in the Mylan School and principal investigator of the research project.
“Estrogen in the body is protective against bone loss. When a woman’s estrogen levels decrease, this leads to brittle bones,” said Witt-Enderby. “Some women go on hormone replacement therapy (HRT) to supplement their loss in estrogen and
progesterone. They usually go on this therapy to feel better, but this therapy also protects their bones. Some women may have an increased risk of breast cancer if they go on HRT, so they are afraid to go on HRT.”
Witt-Enderby and her team are trying to develop another therapy to protect from bone loss, in particular, testing to see if melatonin can prevent bone loss right before menopause. “Our lab has shown positive effects of melatonin on making more of the cells that form bone. In our clinical trial, we are measuring the participants’ bone density and bone activity to test whether melatonin is helpful,” explained Witt-Enderby. “This research is really cutting-edge. We are probably only one of a few labs in the country looking at melatonin for preventing osteoporosis. In addition, we are also assessing whether the women feel better on this therapy because they may be able to sleep better. So, we are surveying them on their sleep patterns and overall well-being.”
This research marks the first time that human clinical trials have been conducted in the Mylan School’s Division of Pharmaceutical Sciences. Witt-Enderby pointed out the importance of screening individuals for this clinical trial, each of who are perimenopausal, to ensure that there are no variables that may influence the results. The participants are first screened via questions in a phone interview. Eligible participants then visit the Pharmacy School’s Wellness Center, where they have their blood pressure and their bone density measured. They also complete questionnaires about their sleep habits and their general well-being, and have their blood work screened. They are then given diaries to record their daily activities over a six-month period.
“With respect to our clinical trial, we want to know if a dose of melatonin that causes shifts in one’s sleep/wake cycle is effective at preventing bone deterioration,” said Witt-Enderby. “The women who participate in this study will be doing something very important for all women, that is, they will have been part of a study that may discover a safe alternative therapy for women to prevent their bone loss. Their participation is critical because osteoporosis is one of the most common skeletal disorders.”
Today in the United States, approximately 10 million individuals have osteoporosis and 34 million more have low bone mass or osteopenia, which places them at an increased risk of developing osteoporosis, said Witt-Enderby. Of the people affected
by this, 68 percent are women. Osteoporosis is characterized by low bone mass and microarchitectural disruption, such that fewer, thinner bony spicules—needle-like structures—are present, leading to less structural support. These hallmark features of
osteoporosis lead to increased skeletal fragility and fracture risk.
“Study candidates will also gain a better understanding about their relative state of their bone mass, whether they participate in the study or not,” noted Witt-Enderby. “They will receive their bone density scores and information on how to improve their bone health to prevent their bones from becoming fragile.”
If the results from the research are promising, Witt-Enderby and her team plan to submit for larger National Institutes of Health grants to run bigger clinical trials at Duquesne in the Wellness Center. Members of Witt-Enderby’s team include: Dr. Christine O’Neil, professor of pharmacy practice and director of the Academic Research Center for Pharmacy Care; Dr. Hilde Berdine, assistant professor of pharmacy practice; Dr. Holly Lassila, assistant professor of pharmacy practice; and Dr. Judith Balk, a physician at Magee-Womens Hospital.
Participants are still needed for this study—compensation is included. Interested women who are 45 and older and are experiencing irregular periods can call 412.396.5874.
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