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FDA approves first IV osteoporosis therapy.(Gynecology)
Last month, the Food and Drug Administration approved an injectable formulation of ibandronate, the first intravenous treatment for osteoporosis to become available and the first bisphosphonate administered once every 3 months.
The approved dose is 3 mg, administered intravenously over 15-30 seconds, by a health care professional, once every 3 months. Ibandronate is the third such formulation approved by the FDA; the first, a daily 2.5-mg formulation approved in 2003, was never marketed because of the availability of more convenient weekly bisphosphonate formulations that were already available at that time. A monthly oral formulation of ibandronate (150 mg) was approved and marketed almost a year ago. Like the monthly formulation, the IV formulation will be marketed under the trade name Boniva, by Hoffmann-La Roche. It will be available "early this year," according to a press release announcing the approval. At press time, the company had not provided information on its cost.
Bypassing the esophagus and stomach--eliminating the need to sit upright without drinking or eating for 30-60 minutes after taking an oral bisphosphonate that is required to reduce the risk of esophagitis and gastritis--is perhaps the most obvious advantage of the IV formulation, said Dr. Robert Recker, director of the Creighton University Osteoporosis Research Center, Omaha, Neb.
Injectable ibandronate can also be used for patients who cannot swallow well, and having the patient come to the office once every 3 months for an injection assures compliance and may be more convenient for patients, added Dr. Recker, who is also professor of medicine and chief of the division of endocrinology at the University. He is a consultant to Roche, and to manufacturers of other osteoporosis therapies, and has conducted clinical trials funded by all these companies.
Dr. Recker was among the investigators in the DIVA (the Dosing Intravenous Administration) study, a randomized, double-blind multinational "noninferiority" study of 1,358 women with postmenopausal osteoporosis. The study compared 2.5 mg of ibandronate daily with the injectable formulation once every ...
- IV ibandronate offers effective nonoral option.(Gynecology)
- Magazine article from: OB GYN News Splete, Heidi August 15, 2005 700+ words
WASHINGTON -- Postmenopausal women with osteoporosis who can't tolerate oral ibandronate may welcome an intravenous option, Michael Bolognese, M.D., reported at an international symposium sponsored by the National Osteoporosis Foundation. One-year results from the Dosing Intravenous Administration
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BOSTON -- Intermittent intravenous ibandronate is at least as effective as daily oral ibandronate for increasing bone mineral density and may be preferable to oral dosing in patients with esophageal disease or compliance problems. There are no fracture data for the intravenous dosing schedule, but
- IV ibandronate rivals oral drug on BMD improvement.(Metabolic Disorders)(body...
- Magazine article from: Family Practice News Sullivan, Michele G. August 1, 2006 700+ words
BOSTON -- Intermittent intravenous ibandronate is at least as effective as daily oral ibandronate for increasing bone mineral density and may be preferable to oral dosing in patients with esophageal disease or compliance problems. There are no fracture data for the intravenous dosing schedule, but
- Intravenous ibandronate injections given every three months: a new treatment...
- Magazine article from: Annals of the Rheumatic Diseases Stakkestad, JA Benevolenskaya, LI Stepan, JJ Skag, A Nordby, A Oefjord, E Burdeska, A Jonkanski, I Mahoney, P October 1, 2003 700+ words
...were randomly allocated to receive IV ibandronate 0.5 mg, 1 mg or 2 mg, or placebo...year's treatment with intermittent IV ibandronate injections produced a dose dependent...were well tolerated. Conclusion: IV ibandronate injections, given every three months...
- Periodic ibandronate injections improve BMD at 2 years.(Endocrinology)
- Magazine article from: Internal Medicine News Wachter, Kerri December 1, 2006 700+ words
...Administration (DIVA) study show that IV ibandronate injections every 2 or 3 months were...femoral neck, and trochanter. "IV ibandronate injections improve BMD at the spine...women were randomized to receive 2-mg IV ibandronate injections every 2 months (454 women...
- Periodic ibandronate injections improve bone density at 2 years.
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...trochanter, and femoral neck. "IV ibandronate injections improve BMD at the spine...were randomized to receive 2-mg IV ibandronate injections every 2 months (454 women), 3 mg IV ibandronate every 3 months (472 women), or...
- Monthly ibandronate superior to daily dosing.(Clinical Rounds)
- Magazine article from: OB GYN News Wendling, Patrice July 1, 2006 700+ words
...years, with osteoporosis to four treatment groups: 2-mg IV ibandronate injection every 2 months plus daily oral placebo; 2.5...ibandronate plus placebo IV injection every 2 months; 3-mg IV ibandronate every 3 months plus daily oral placebo; and 2.5-mg...
- BMD gains superior on monthly bisphosphonate.(Bone mineral density)
- Magazine article from: Family Practice News Wendling, Patrice July 1, 2006 700+ words
...years, with osteoporosis to four treatment groups: 2-mg IV ibandronate injection every 2 months plus daily oral placebo; 2.5...ibandronate plus placebo IV injection every 2 months; 3-mg IV ibandronate every 3 months plus daily oral placebo; and 2.5-mg...
- Study finds higher-dose ibandronate regimen effective and safe.
- Newspaper article from: Biotech Week July 21, 2004 700+ words
...2004;34(5):881-889). "In a recent fracture prevention study," the researchers explained, "1 mg and 0.5 mg iv ibandronate injections, given once every 3 months, were shown to dose-dependently increase lumbar spine and hip bone mineral density...
- Ibandronate injections must be adequately dosed to provide good therapy.
- Newspaper article from: Drug Week July 23, 2004 700+ words
...placebo-controlled, randomized Phase III study [to explore] the antifracture efficacy and safety of 1 and 0.5 mg iv ibandronate injections, given once every 3 months, in 2,862 women (55-76 years) with postmenopausal osteoporosis [one to four...
Source: HighBeam Research, FDA approves first IV osteoporosis therapy.(Gynecology)