Low doses of the medication lasofoxifene can reduce the risk of vertebral and non-vertebral fractures, breast cancer, coronary heart disease, and stroke in postmenopausal women with osteoporosis, says a new study published in a recent issue of the New England Journal of Medicine.
Lasofoxifene is a non-steroidal selective estrogen receptor modulator (SERM) that has been shown to decrease bone loss and bone weakening and reduce cholesterol levels, all common problems in postmenopausal women. Its impact on other health issues for this population, however, was not well understood.
"This is the first SERM that reduces the risk of all of these conditions at once," asserts Dr. Steven Cummings, of the San Francisco Coordinating Center at the California Pacific Medical Center Research Institute, who was the lead author of the study.
"Not only did it reduce vertebral fractures, which was not unexpected, it also reduced the risk of non-vertebral fracturesinjuries to the arms, legs, ribs, hipsthat are the most common injuries to people with osteoporosis and the main causes of disability," Cummings says.
The researchers followed more than 8,500 women, ages 59 to 80, over the course of five years. Two-thirds of the women were given a daily dose of lasofoxifeneeither 0.25mg or 0.5mgand the other third was given a placebo.
The women were given what are called lateral spine radiographs at 12, 24, 36, and 60 months to measure bone density and identify possible fractures. The women also underwent annual mammograms and clinical breast exams to detect breast cancer.
At the end of the five years, patients who took lasofoxifene experienced fewer vertebral fractures than the placebo groupa 58 percent reduction in the patients taking 0.5mg a day and 31 percent in the lower dose groupand fewer non-vertebral fractures, at 24 percent and 10 percent, respectively. Those taking lasofoxifene also experienced increases in bone density compared with the placebo group.
Patients taking lasofoxifene experienced a reduction in their risk of what's called estrogen receptor positive breast cancer81 percent and 48 percent, respectivelyand a reduction in low-density lipoprotein, or LDL , the so-called bad cholesterol, of around 16 percent.
The researchers say, though, that the results weren't all positive. Patients taking lasofoxifene were at higher risk of experiencing a blood clot.
"We know that other SERMs, such as raloxifene, also increase a person's risk of blood clots, so this finding was not a surprise to us," Cummings says. "Even so, we have never found a treatment that has the array of beneficial effects as lasofoxifene with fewer serious side effects. With other treatments, such as Tamoxifen and estrogen, we have seen an increased risk for women of endometrial cancer, but in lasofoxifene we did not see that at all."
While the study results are promising, the drug is unlikely to be available to women in the U.S. any time soon. The FDA recently rejected pharmaceutical company Pfizer's request for approval, meaning that while it is approved and available in Europe, it's not available here in the U.S.
Cummings and several of the other researchers involved in this study received consulting grants from Pfizer, the manufacturer of lasofoxifene. To reduce questions about conflict of interest or bias, an independent scientific advisory committee, of investigators not employed by Pfizer, oversaw the study design and analysis and wrote the paper and approved it for publication.