Clinical Trial at Duquesne University to Examine Natural Bone Treatment
In August, a Duquesne University pharmacology professor will start a clinical trial to study whether a combination of melatonin, vitamins and minerals successfully treats bone loss.
Three years ago, Dr. Paula Witt-Enderby, Duquesne professor of pharmacology, conducted a trial examining 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 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 will be based in the Center for Pharmacy Care located in the Muldoon Building at 1000 Fifth Ave. 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. Each study participant will be asked to keep a diary and complete seven visits.
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.
Members of Witt-Enderby's team include graduate assistant Sifat Maria, and Duquesne professors Drs. Holly Lasilla and Chris O'Neil. For more information about participating, contact Maria.