Released 01 October 2008

New osteoporosis drug 'shows good results' in Phase III trial

A new drug has shown to have preventive effects on osteoporosis and has uterine safety in postmenopausal women with normal to low bone mass, according to research presented at the 19th annual meeting of the North American Menopause Society (NAMS).

Scientists from Rapid Medical Research in Ohio studied 331 postmenopausal women between 45 to 60 years of age, none of whom had had a hysterectomy, and all whom had normal to low bone mass, DG News reports.

The patients were treated with arzoxifene 20 mg/day in 172 women, while 159 were given a placebo. All study participants were given daily supplements of 500mg elemental calcium. Bone mass density (BMD) was calculated every six months.

At the end of the two-year Phase III study, researchers found that arzoxifene significantly increased lumbar spine and total hip BMD.

Neither endometrial hyperplasia (thickening of the lining on the womb) nor cancer occurred in the arzoxifene group, although two subjects were affected in the placebo group.

"It's another new molecule in the whole family of SERMs [selective oestrogen receptor modules], oestrogen agonists/antagonists. Clearly, it's more potent than raloxifene. So from that point of view, call it the next generation," commented lead researcher Dr Wulf Utian.

A spokesman for the Arthritis Research Campaign said the Phase III results looked promising, and that the new drug was the latest in a long line of new treatments for osteoporosis.
ADNFCR-1096-ID-18806126-ADNFCR

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