UNMC partnering with Theranova, LLC to study bone health in women

August 13, 2019

Image with caption: The lead investigators on the Spry Belt study are Nancy Waltman, Ph.D. (left) and Laura Bilek, Ph.D.

The lead investigators on the Spry Belt study are Nancy Waltman, Ph.D. (left) and Laura Bilek, Ph.D.

The University Of Nebraska Medical Center College of Allied Health Professions is collaborating with Theranova, LLC, an experienced medical device development company, to conduct a federally funded research study to evaluate effectiveness of the Spry Belt in preventing bone loss in post-menopausal women. 
 
The Spry Belt is worn like a belt for 30 minutes a day, five days a week, and delivers energy that may help prevent bone loss.
 
Laura Bilek, Ph.D., a professor and physical therapist in the UNMC College of Allied Health Professions is the principal investigator. Nancy Waltman, Ph.D., a professor and advanced practice registered nurse in the UNMC College of Nursing, is a co-investigator on the project.
 
Ten million Americans have severe bone loss or osteoporosis, and 34 million have low bone mass, known as osteopenia. Eighty percent of patients with osteopenia and osteoporosis are women. Without treatment, women with low bone mass will likely continue to lose bone, develop osteoporosis and have a greater risk of fractures.
 
"One in every two women will suffer an osteoporotic fracture during her lifetime," said Dr. Bilek, adding that "despite the high prevalence of low bone mass, few treatment options exist."
 
Current clinical practice guidelines include increasing calcium and vitamin D intake and discussing the importance of high impact exercise, Dr. Waltman said.
 
While this combination can be effective at maintaining bone health, daily compliance with high impact exercise is low in aging populations, she said.
 
Participants will be randomly assigned to wear an active Spry Belt or a placebo Spry Belt. After 12 months, outcomes measured will include lumbar bone strength and hip and spine bone mineral density.  Women also will be asked to take study supplied calcium and vitamin D supplements.  All study procedures and supplies are provided at no cost to enrolled subjects.
 
"Fractures are devastating to older adults. A non-invasive treatment for women at risk would be a dramatic contribution to health care decreasing the number of fractures as well as the associated disability experienced by older adults," Dr. Bilek said.
 
Women 50 or older living in the area are currently being recruited for the study.  Study information can be found at:  https://www.unmc.edu/alliedhealth/research/projects/sprybelt/index.html or by contacting Kara M. Smith at beltstudy@unmc.edu or 402-559-6584.
 
All study personnel have disclosed all potential financial conflicts of interest as required and are in full compliance with the UNMC Conflict of Interest Policy.
 
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