IOF PRESS RELEASE 13
MAY 12, 2002
Lisboa Congress Center, Portugal
Oral ibandronate therapy (intermittent doses) reduces fracture risk in postmenopausal women
Oral ibandronate, a bisphosphonate compound, was shown in a large phase III study to be effective and safe in reducing the incidence of osteoporotic bone fractures in postmenopausal women. The results of the Oral Ibandronate Fracture Study, presented at the IOF World Congress on Osteoporosis in Lisbon, were reported by Dr. Pierre Delmas, Université Claude Bernard, Lyon, France and colleagues.
"This is the first time a biphosphonate agent shows efficacy with a truly intermittent regimen", says Delmas.
Oral bisphosphonates, while of recognized efficacy in the treatment and prevention of osteoporosis, are hindered by poor gastrointestinal absorption and thus have stringent dosing requirements. Ibandronate, a nitrogen-containing bisphosphonate, is being studied as an alternative to existing compounds in its class and has been administered on a novel dosing schedule incorporating a unique drug-free interval. In the present study, 2,946 women at least five years beyond the onset of menopause and with a bone mineral density (BMD) T-score of less than 2.0 SD at the lumbar spine were randomized to treatment with placebo or active drug. Ibandronate was administered either once daily (2.5 mg) or on the new dosing schedule, in which the drug was given on alternate days for 12 doses, repeated every three months. The total dose of ibandronate administered in the two active drug arms of the trial was comparable. All patients also received daily oral supplements of calcium and vitamin D (500 mg and 400 IU, respectively). The primary endpoint of the study was a reduction in the incidence of new vertebral fractures after three years.
The risk of radiologically verified vertebral fracture was reduced by 62% and 50% in the daily ibandronate and cyclical ibandronate treatment groups, respectively, as compared with placebo. A significant reduction in the risk of nonvertebral fractures was also obtained with ibandronate among a subgroup of patients with femoral neck BMD T-scores of less than 3.0 SD. Markers of bone turnover were suppressed significantly and consistently with both bisphosphonate treatment regimens. The study drug was well tolerated in both dosage groups, and the unique dosing schedule incorporating a prolonged drug-free interval was considered to be a convenient treatment alternative to existing bisphosphonate therapies. "Ibandronate opens the door to more friendly and more convenient treatment of osteoporosis", adds Delmas.
In a separate poster presentation, the Oral Ibandronate Study Group reported that weekly dosing of oral ibandronate was preferable to daily administration of reference bisphosphonates, measured on the basis of patient preference, convenience and compliance. This multi-center, double-blind, placebo-controlled phase II/III trial enrolled 630 postmenopausal women who were treated with ibandronate (5, 10 or 20 mg) or placebo for two years. The study was designed to determine efficacy, safety and the optimum dose of once-weekly ibandronate for the prevention of osteoporosis. At the end of the two-year treatment period, the investigators determined that the most significant gains in BMD were obtained with the dose of 20 mg, although BMD was maintained with the 10-mg dose. Once-weekly ibandronate was well tolerated, and no safety concerns were reported.
Ibandronate has been available since 1996 for the treatment of hypercalcemia. It is not yet marketed in any country for the indication of osteoporosis, but phase III trials are underway for both treatment and prevention of postmenopausal osteoporosis, with plans to file for approval of this indication later this year.
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: www.osteofound.org/wco/2002
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