Three years ago, Dr. Paula Witt-Enderby, professor of pharmacology, conducted a clinical study that examined whether melatonin, a natural molecule released nightly in the body and a popular over-the-counter sleep aid, could help prevent bone loss in healthy women entering menopause. The answer was yes.
Building on this study, Witt-Enderby’s work, now in collaboration with Dr. Mark Swanson, co-investigator and a naturopathic physician, has moved from prevention to treatment. With a Mylan School of Pharmacy translational research grant and a study formulation from Pure Encapsulations Inc. of Sudbury, Mass., Witt-Enderby’s team will conduct a clinical trial, starting in August, to examine whether a formulation of melatonin, strontium citrate and vitamins D3 and K2 can treat bone loss in women with thinning bones (osteopenia).
“Strontium has profound health promoting effects in most organs and tissues of the body, including bone. We hypothesize that melatonin will have an enhancing or ‘synergistic’ effect with strontium in bone that is greater than strontium alone and at a one-third lower dose,” Swanson said, explaining that the mineral strontium’s impact on bone formation is much more powerful than calcium’s. “We think it makes better bone sense when given all together at night to produce a time-dependent enhancement of bone formation or ‘chrono-synergy’ effect.
“Current drug treatments for osteoporosis are not ideal,” Witt-Enderby said. “They have only a 30 percent compliance rate, which really drops after six months. What’s needed is a convenient, safer and better-tolerated treatment. Many women are worried about having to take a powerful drug for months to years before they see results, so a more natural treatment is appealing. In the end, it’s all about safely preventing fractures and improving quality of life.”
The trial, starting in August, will be based in the Center for Pharmacy Care located in the Muldoon Building at 1000 Fifth Ave.
Members of Witt-Enderby’s team include graduate assistant Sifat Maria, and professors Drs. Holly Lasilla and Chris O’Neil.
For the double-blind, placebo-controlled study, Witt-Enderby seeks 20 female postmenopausal volunteers who have been diagnosed with osteopenia-related bone loss and who are considering treatment to increase bone density.
Participants in the yearlong trial will receive:
- Two free DXA scans to measure lumbar spine and hip bone density
- Free blood tests for bone formation cells, vitamin D3 and melatonin levels
- Free clinical health assessments, symptom and quality of life questionnaires
- Free study medications
- Free parking.
Each study participant will be asked to keep a diary and complete seven visits. For more information about participating, contact Maria.
Grants Received [February 25, 2015]
Funds totaling $552,625 were recently received by the Mylan School of Pharmacy.
Faculty & Staff Spotlight [February 25, 2015]
What have Drs. Henk ten Have and Matthew Hyland been up to?
DU in the News [February 2015]
News coverage highlighting Duquesne’s experts and initiatives.
- Grants Received [February 25, 2015]
New Crowdfunding, Urban Plunge Initiatives Boost Cross-Cultural Missions
While Spring Break provides an opportunity for students to vacation or stay home for relaxation, 65 Duquesne students and staff will take this time to embark on Cross-Cultural Mission Experiences (CCME) that will impact six different areas in the country.
- New Crowdfunding, Urban Plunge Initiatives Boost Cross-Cultural Missions