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Hormone Replacement Therapy/Alendronate Combination Safe, Effective for Prevention and Treatment of Osteoporosis in Older Women

PITTSBURGH, PA -- May 21, 2003 -- Elderly women with osteoporosis can significantly and safely improve their bone mass with a combination therapy of hormone replacement and the bisphosphonate alendronate (Fosamax). The findings are published in the May 21 issue of the Journal of the American Medical Association by University of Pittsburgh researchers.

"Our study found that a combination therapy of hormone replacement and alendronate was well tolerated by elderly women with low bone mass. After three years of treatment, these women showed significantly greater increases in bone mass than we saw in similar women taking only one of the therapies," said lead author Susan Greenspan, M.D., professor of medicine at the University of Pittsburgh School of Medicine and director of the Osteoporosis Prevention and Treatment Center at the University of Pittsburgh Medical Center. "Combination therapy is a safe, viable option for postmenopausal women who have been unable to improve their bone density with an individual therapy, or in women with osteoporosis severe enough to require a greater increase in bone density."

Earlier research has suggested similar results with younger women, but up to now little data were available on the effectiveness and safety of combination therapy in older, post-menopausal women. The study was conducted with 373 women aged 65 to 90 years. At baseline, participants as a group had bone mass thin enough to be classified as osteopenia, a precursor of osteoporosis. Thirty-four percent of the women had osteoporosis.

Participants were evenly randomized to receive hormone replacement therapy (HRT) (conjugated estrogen with or without medozyprogesterone) plus alendronate, HRT alone, alendronate alone, or placebo. All received calcium and vitamin D supplements.

After three years, dual-energy X-ray absorptiometry (DXA) scans showed that participants taking combination therapy had greater improvements in bone mineral density (BMD) at the hip and spine than did those participants taking HRT or alendronate alone, or placebo.

For instance, the mean increase in BMD at the hip was 5.9 percent with combination therapy, 4.2 percent with alendronate, 3.0 percent with HRT and 0.0 percent with placebo. At the lumbar spine the mean increases in BMD were 10.4 percent with combination therapy, 7.7 percent with alendronate, 7.1 percent with HRT and 1.1 with placebo.

Also, in comparing HRT with alendronate, researchers found that participants taking alendronate alone had greater improvements in BMD at the hip.

While the study was not designed to examine fractures as an outcome, a higher bone density is usually associated with fewer fractures.

"We applied a logistic model to our data and determined that combination therapy would provide an additional 10 percent reduction in fracture over HRT alone and an additional 8 percent over alendronate alone," said Dr. Greenspan.

"These results can help elderly women decide whether the potential risk inherent in HRT use is worth taking to reduce the risk of fracture."


SOURCE: University of Pittsburgh Medical Center

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