The five-year grant from the National Institutes of Health, National Institute of Nursing Research, may provide an alternative treatment for breast cancer survivors, most of whom cannot take hormone replacement therapy, the most frequently used preventive treatment.
Researchers are recruiting 273 women, ages 35 to 70, in a 100-mile radius of Omaha, Lincoln, Kearney and Scottsbluff.
In 2002, about 205,000 women in the United States will be diagnosed with breast cancer, according to the American Cancer Society. Osteoporosis is a significant problem in women after menopause, especially breast cancer survivors. More than 50 to 70 percent of women under the age of 50 who are treated with adjuvant chemotherapy experience ovarian failure and early menopause, resulting in a long period of estrogen deprivation.
"The good news is that more women are surviving breast cancer than ever before, unfortunately, they have another concern -- they may be at greater risk for osteoporosis than healthy women, and the onset of osteoporosis may occur at an earlier age," said Nancy Waltman, Ph.D., associate professor of nursing, UNMC College of Nursing Lincoln Division and principal investigator of the study.
Impact of strength and weight training programs
Researchers will study whether a progressive strength and weight training exercise program can boost the effectiveness of risedronate, calcium, and vitamin D in improving bone mineral density in these post menopausal breast cancer survivors. Researchers were encouraged with results from a recently concluded one-year pilot study.
"We want to know just how important exercise is," Dr. Waltman said. "We know the medication and supplements work, but it's not enough." The new study will evaluate how important exercise is in minimizing bone loss or reestablishing bone strength, she said.
In the new, larger study, researchers also expect to find breast cancers survivors who aren't aware they have bone loss. In the pilot study, Dr. Waltman said 80 percent of the women had bone loss, but many of them were unaware of it because they'd never been tested.
"Many of our pilot study participants didn't even realize that osteoporosis was something they should be concerned about. Less than half of the women had bone mineral density screenings before the study," Dr. Waltman said. "Our findings suggest the need for health care providers to educate breast cancer survivors not on hormone replacement therapy that they are at risk for osteoporosis and they should be screened."
Osteoporosis causes deterioration of bone tissue and leads to bone fragility and an increased susceptibility to fractures of the hip, spine and wrist. According to the National Osteoporosis Foundation, osteoporosis is a major public health threat for more than 28 million Americans. Caucasian and Asian women are at increased risk for osteoporosis.
"Osteoporotic bone becomes very thin and fragile," said Janice Twiss, Ph.D., UNMC associate professor of nursing and co-investigator of the study. "Women get fractures in their spine simply by reaching up to get something, sneezing or walking down steps. Women can live a long time, but they're disabled. Some end up in a nursing home."
Participating in the study
Researchers are recruiting women with a history of stage 0, stage I, or stage II breast cancer, who are not candidates for hormone replacement therapy. Eligible study participants will receive free evaluations, treatment and follow up during the study.
The new study will be a randomized clinical trial comparison of two treatment groups. For two years, both groups will follow the same protocol of taking risendronate, a drug shown to rebuild bone mass, and calcium with vitamin D supplements. However, one group also will participate in an upper and lower body strength weight training program to strengthen muscle and bone mass in the hip, spine and wrist.
The group receiving exercise therapy will meet with an exercise trainer to learn home-based strength-training exercises, and in the second year will progress to using weight machines at a fitness facility. Evaluation of participants' compliance with the exercise regimen is another important part of the study.
"We've recognized compliance to strength-weight training exercises and even taking medications can be a problem over time, so we've included strategies to address this," Dr. Waltman said.
The high cost of osteoporosis
The annual cost of osteoporosis is estimated at $13.8 billion -- more than the annual cost of both congestive heart failure and asthma.
"The reason osteoporosis is so costly is that 90 percent of hip fractures are caused by osteoporosis," Dr. Waltman said. "Hip fractures require hospitalization more than 95 percent of the time and impair lifestyle over 50 percent of the time. About 15 to 20 percent of patients with hip fractures require long-term care, and 12 to 20 percent of patients with hip fractures die of complications."
Prevention and treatment of osteoporosis by increasing bone mineral density and muscle strength may decrease the chronic disabilities associated with osteoporosis and improve quality and quantity of life, researchers say.
For more information
Drs. Waltman and Twiss published pilot study results of bone mineral density in postmenopausal breast cancer survivors last June in the Journal of the American Academy of Nurse Practitioners.
Other co-investigators participating in the study are: Carol Ott, Ph.D., UNMC College of Nursing Kearney Division; Gloria Gross, Ph.D., UNMC College of Nursing West Nebraska Division; Ada Lindsey, Ph.D., UNMC College of Nursing, Omaha; Timothy Moore, M.D., UNMC College of Medicine, Omaha; and Kris Berg, Ed.D, of the University of Nebraska at Omaha.
For more information, in Omaha, call Jan Twiss, Ph.D., 559-6571; Lincoln, Nancy Waltman, Ph.D., (402) 472-7354; Kearney, Carol Ott, Ph.D., (308) 865-8147 and Scottsbluff, Gloria Gross, Ph.D., (308) 632-0412.
Photo: Jan Twiss, Ph.D., co-investigator of the osteoporosis grant, watches Linda Hitt of Omaha demonstrate the proper way to do upper body strength weight training. Hitt participated in UNMC's osteoporosis pilot study last year.