Intravenous bisphosphonate administration is at least as effective as oral dosing, and may be an important option for patients in reducing fracture risk related to postmenopausal osteoporosis.
June 26, 2005 (Press Release) --
EMBARGOED FOR RELEASE UNTIL 14.30 (CEST) ON 27 JUNE
Geneva, Switzerland—Bisphosphonates, such as ibandronate, have been shown to be effective in reducing the risk of fracture related to postmenopausal osteoporosis when taken orally on a daily basis. However, oral bisphosphonates may not be suitable for all patients (e.g., patients with pre-existing gastrointestinal disorders). Intravenous administration of the medication is at least as effective as oral dosing, and may be an important option for patients who are unable to take the oral regimen. Silvano Adami, M.D. reported these findings today at the Second Joint Meeting of the European Calcified Tissue Society and the International Bone and Mineral Society.
Dr. Adami and his team, which are participating in the two-year Dosing Intravenous Administration (DIVA) study, investigated the efficacy and safety of intravenous ibandronate with an extended period of time between doses, and compared it to the efficacy and safety of the established daily oral ibandronate regimen. The DIVA study involves 1,393 postmenopausal women, aged 55-80, with osteoporosis. All were given daily calcium and vitamin D (both of which form part of the treatment regimen for osteoporosis) and then were divided into three groups.
Group 1 was given 2 mg ibandronate injections every two months. Group 2 was given 3 mg ibandronate injections every three months. Group 3 was given 2.5 mg daily oral ibandronate (the approved regimen). The primary measurement of efficacy was the increase in lumbar spine bone mineral density (BMD).
Results from the DIVA study after one year indicate that the increases in lumbar spine BMD were 5.1 percent, 4.8 percent, and 3.8 percent respectively for Groups 1, 2, and 3. Compared to the daily oral regimen, all intravenous regimens showed greater increases in total hip, femoral neck and hip trochanter BMD. In all groups, the researchers also observed similar reductions in the biochemical markers of bone resorption, which is the bone loss due to the action of osteoclasts (cells that break down bone). The overall incidence of side effects was similar across all groups.
“Ibandronate injections are at least as effective and similarly well tolerated as the oral ibandronate regimen in postmenopausal women with osteoporosis,” says Dr. Adami. “Injectable ibandronate may well be of significant utility in patients for whom oral bisphosphonates are contraindicated or unsuitable,” he adds.
For more information about Dr. Adami’s study, please visit www.ects-ibms-2005.org.
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The European Calcified Tissue Society (ECTS) is the major organization in Europe for researchers and clinicians working in the field of calcified tissues. The International Bone and Mineral Society (IBMS) is the international society working to promote the generation and dissemination of knowledge about bone and mineral metabolism.
The ECTS-IBMS Second Joint Meeting, held in Geneva, Switzerland, 25-29 June 2005, brings together some 3,000 researchers, clinicians, physicians and other allied health professionals, will offer participants the opportunity to enhance their knowledge of bone biology, bone diseases and their correlation to mineral metabolism.
###
Geneva, Switzerland—Bisphosphonates, such as ibandronate, have been shown to be effective in reducing the risk of fracture related to postmenopausal osteoporosis when taken orally on a daily basis. However, oral bisphosphonates may not be suitable for all patients (e.g., patients with pre-existing gastrointestinal disorders). Intravenous administration of the medication is at least as effective as oral dosing, and may be an important option for patients who are unable to take the oral regimen. Silvano Adami, M.D. reported these findings today at the Second Joint Meeting of the European Calcified Tissue Society and the International Bone and Mineral Society.
Dr. Adami and his team, which are participating in the two-year Dosing Intravenous Administration (DIVA) study, investigated the efficacy and safety of intravenous ibandronate with an extended period of time between doses, and compared it to the efficacy and safety of the established daily oral ibandronate regimen. The DIVA study involves 1,393 postmenopausal women, aged 55-80, with osteoporosis. All were given daily calcium and vitamin D (both of which form part of the treatment regimen for osteoporosis) and then were divided into three groups.
Group 1 was given 2 mg ibandronate injections every two months. Group 2 was given 3 mg ibandronate injections every three months. Group 3 was given 2.5 mg daily oral ibandronate (the approved regimen). The primary measurement of efficacy was the increase in lumbar spine bone mineral density (BMD).
Results from the DIVA study after one year indicate that the increases in lumbar spine BMD were 5.1 percent, 4.8 percent, and 3.8 percent respectively for Groups 1, 2, and 3. Compared to the daily oral regimen, all intravenous regimens showed greater increases in total hip, femoral neck and hip trochanter BMD. In all groups, the researchers also observed similar reductions in the biochemical markers of bone resorption, which is the bone loss due to the action of osteoclasts (cells that break down bone). The overall incidence of side effects was similar across all groups.
“Ibandronate injections are at least as effective and similarly well tolerated as the oral ibandronate regimen in postmenopausal women with osteoporosis,” says Dr. Adami. “Injectable ibandronate may well be of significant utility in patients for whom oral bisphosphonates are contraindicated or unsuitable,” he adds.
For more information about Dr. Adami’s study, please visit www.ects-ibms-2005.org.
###
The European Calcified Tissue Society (ECTS) is the major organization in Europe for researchers and clinicians working in the field of calcified tissues. The International Bone and Mineral Society (IBMS) is the international society working to promote the generation and dissemination of knowledge about bone and mineral metabolism.
The ECTS-IBMS Second Joint Meeting, held in Geneva, Switzerland, 25-29 June 2005, brings together some 3,000 researchers, clinicians, physicians and other allied health professionals, will offer participants the opportunity to enhance their knowledge of bone biology, bone diseases and their correlation to mineral metabolism.
###
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