IOF World Congress on Osteoporosis

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MAY 14, 2002

Lisboa Congress Center, Portugal

Late-Breaking News

Intranasal estrogen shown to be effective against bone loss but with less undesirable effects on reproductive tissues

In a late-breaking news session at the IOF World Congress on Osteoporosis, Danish and French investigators reviewed promising findings obtained in a large clinical study evaluating the efficacy of a novel new estrogen replacement therapy in the prevention of postmenopausal osteoporosis.

Dr. Claus Christiansen of the Center for Clinical and Basic Research in Ballerup, Denmark and colleagues described the administration of the hormone 17beta-estradiol (E2) by the nasal route as a "new concept of pulsed estrogen therapy." The product reduces climacteric symptoms of menopause and reduces bone loss while avoiding undesirable estrogen stimulation of reproductive tissues. Three hundred eighty six early postmenopausal women (average age 52.7 years, average duration of menopause 2.2 years) with osteopenia, as manifested by mean spinal T-scores of -1.1, were enrolled in the randomized, double-blind, placebo-controlled study.

Trial participants were assigned to treatment with daily intranasal 17beta-estradiol (E2) (150 mcg/day or 300 mcg/day) or a placebo nasal spray, combined cyclically with micronized progesterone (200 mg/day). All treatments were administered for two years as a single spray in each nostril, taken in the evening. Efficacy was determined by dual X-ray absorptiometry (DXA) measurements of bone mineral density (BMD) in the spine, hip and forearm at baseline and every six months, and by periodic determination of urinary type I collagen C telopeptide (CTX) and serum osteocalcin levels.

The results confirmed that bone mineral density in intranasal estrogen-treated women increased significantly at the end of the study period as compared to placebo-treated controls, with a dose effect for the estrogen therapy. Spine bone mineral density increased by 2.20% and 3.97%, respectively, in the 150- and 300-mcg/day S-21400 groups, while femoral neck bone mineral density increased by 0.07% and 1.15%, respectively. Bone mineral density of the spine and femoral neck decreased over the same time period among placebo-treated women (-3.5% and -4.02%, respectively). Urinary CTX decreased by 40.0% and 46.1% with high- and low-dose S-21400 therapy, respectively, while serum osteocalcin levels dropped by 21.8% and 27.2%, respectively. Study participants reported the intranasal estrogen product to be well tolerated.

Dr. Christiansen added, "17beta-estradiol effectively prevents postmenopausal bone loss with a great gain in bone mineral density with the 300 mcg/day dose without a decrease of tolerance as compared with 150 mcg/day dose."

The International Osteoporosis Foundation (IOF) is a worldwide organization dedicated to the fight against osteoporosis around the world. It brings together scientists, physicians, patient societies and corporate partners. Working hand in hand with its 139 member societies in 71 countries and other healthcare-related organizations around the world, IOF encourages awareness and prevention, early detection and improved treatment of osteoporosis.

The IOF World Congress on Osteoporosis is being held May 10-14, 2002 in Lisbon, Portugal. Some 5,000 participants are expected for the congress, expected to be the largest gathering ever of osteoporosis specialists from around the world. Abstracts from the congress are published in a supplementary volume of the journal Osteoporosis International. For more information visit the congress website:

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