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The Pharmaceutical Journal
Vol 269 No 7227 p802
7 December 2002

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New drug raises bone density more than alendronate

A bone formation agent, teriparatide (Forteo), has been found to increase bone mineral density in the lumbar spine by five times more than the bisphosphonate alendronate (Fosamax), new data show.

Teriparatide, which is being developed by Eli Lilly, is a recombinant human parathyroid hormone of rDNA origin. It stimulates formation of new bone by increasing the number and action of osteoblasts, rather than slowing or stopping bone loss by inhibiting osteoclast-mediated bone resorption.

In the Forteo alendronate comparison trial (FACT), 206 postmenopausal women with osteoporosis-related fractures were randomly assigned to receive either a subcutaneous injection of teriparatide 20µg plus placebo orally or alendronate 10mg plus a placebo injection, daily.

After six months of treatment, a 14.6 per cent increase in bone mineral density was seen with teriparatide compared with a 2.9 per cent increase with alendronate. Teriparatide also increased a marker of bone formation by 217 per cent and a marker of bone resorption by 59 per cent, whereas alendronate decreased a marker of bone formation by 67 per cent and a marker of bone resorption by 72 per cent. The researchers comment that the increase in bone mineral density with teriparatide may be the result of the substantial increase in bone formation.

Data were presented at the World Health Organization's third international symposium on clinical and economic aspects of osteoporosis and osteoarthritis held in Barcelona last month.

A spokesman for Merck Sharp & Dohme, manufacturer of alendronate, told The Journal that alendronate has been consistently shown to reduce the risk of vertebral and hip fractures by about 50 per cent and is available as a once weekly tablet rather than a daily injection.

Teriparatide approval Teriparatide injection received approval by the United States Food and Drug Administration last week for both the treatment of osteoporosis in postmenopausal women and for increasing bone mass in men with primary or hypogonadal osteoporosis who are at high risk of fractures. The drug is expected to receive a licence in the United Kingdom for both indications during 2003.

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