Intravenous Bisphosphonate Treatment For Postmenopausal Osteoporosis

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, MD 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 ects-ibms-2005.


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.


State-of-the-art research on bone and mineralized tissue, along with diagnostic and therapeutic aspects of metabolic bone
diseases will be presented through symposia, workshops, training courses, lectures, posters and Meet the Professor sessions.
Topics covered at the meeting include: osteoporosis assessment, treatment, genetics and physiology; clinical disorders other
than osteoporosis; stem cells and bone cells; nutrition and bone; metabolic bone disease; bone imaging and assessment; and
bone development.


ects-ibms-2005