HRT May Prevent Fractures in Postmenopausal Women Without Adverse Side Effects

Reprinted with permission of Rush Center For Clinical Studies

Researchers at the Rush Center for Clinical Studies at Rush-Presbyterian-St. Luke’s Medical Center in Chicago will investigate whether the hormone replacement therapy tibolone prevents spinal fractures in osteoporotic postmenopausal women.

Osteoporosis is characterized by low bone mass that leads to an increased risk of fracture.

Many patients do not realize that they are affected by osteoporosis until they experience a fracture of the spine, hip, or wrist. Osteoporosis is most common among females following menopause, but also occurs in males. Millions of people suffer from osteoporosis in the United States and by 2020 the numbers are expected to double.

Tibolone has been used extensively in Europe for several years and the medication has a good safety track record, said Dr. Joel Block, director of the Rush Center for Clinical Studies and a rheumatologist.

"Tibolone is a synthetic hormone replacement therapy that may have advantages over other HRTs," said Block. He said animal studies have shown that tibolone actually helps shrink breast cancer tumors with much the same effectiveness of Tamoxifen. "In patients who have used it in Europe, they report a significant reduction in breast tenderness and uterine bleeding and vaginal discomfort."

Rush is the only medical center in Chicago participating in the study and is seeking to enroll over 100 volunteers in this five-year study. All patients will receive calcium and vitamin supplements, bone mineral density (DEXA) scans, mammograms, x-rays, electrocardiograms, and other medical assistance and attention. In addition to this regimen, half the patients will take a daily dose of tibolone while the other half will receive a placebo.

Block said the medication’s effectiveness will be tested by the rate of vertebrae fractures the women experience. He pointed out that currently, women over age 62 with osteoporosis and who score low on bone density tests have a 50 percent chance of suffering a broken hip or fractured vertebrae.

"Of these patients, 25 percent die and 25 percent are treated in a chronic care facility such as a nursing home," he said. "So, it’s critically important that we find medications or approaches to prevent osteoporosis and we think tibolone is promising in this regard."

To enroll in the study, contact the Rush Center For Clinical Studies at 312-942-2167.