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| |  A Year of Oral Ibandronate Improves Bone Quality in Women With Postmenopausal Osteoporosis: Presented at ASBMR By Louise Gagnon MONTREAL -- September 13, 2008 -- The use of oral ibandronate over 1 year led to increases in bone mineral density (BMD) in postmenopausal women with osteoporosis, according to research presented here at the American Society for Bone and Mineral Research (ASBMR) 30th Annual Meeting. "We looked at ibandronate versus placebo in [examining] noninvasive parameters of bone quality [for this population]," said Alan Kivitz, MD, Altoona Center for Clinical Research, Duncansville, Pennsylvania, speaking in an interview during a poster session here on September 13. Improving bone quality in this population would likely minimise the risk of hip fracture in the future, added Dr. Kivitz. Dr. Kivitz and his fellow researchers initially enrolled 97 postmenopausal women in a 1-year, randomised, double-blind study of oral ibandronate (150 mg monthly) versus placebo. In the intent-to-treat population of 93 women, 47 subjects received ibandronate and 46 received placebo. The primary study endpoint was the mean percent change in integral total hip quantitative computed tomography (QCT) BMD from baseline to 12 months. Ibandronate users achieved a treatment difference of 2.2% in integral BMD of the total hip between baseline and 12 months (P = .005). There were greater gains in integral and volumetric BMD in the total hip over 12 months. Bone quality was measured through the use of QCT as well as through finite element analysis (FEA), employed in engineering to examine the integrity of design structures such as bridges, noted Dr. Kivitz. FEA modelling supported that ibandronate maintained femoral strength through an impact on both peripheral and trabecular strength, whereas placebo patients experienced diminished femoral and trabecular strength. Results demonstrated the following differences between patients who received ibandronate and those who received placebo: total hip (integral, 1.5% vs -1.0%, respectively; trabecular; 2.6% vs -2.9%, respectively); trochanter (integral, 2.5% vs -1.0%, respectively); and femoral neck (integral, 0.8% vs -1.4%, respectively). "There was a significant enhancement of measures in bone quality [in patients who received ibandronate] compared to patients who got placebo," said Dr. Kivitz, adding that the measurements demonstrate increases in structural integrity above and beyond bone density. All subjects were aged 55 to 80 with BMD T-scores <=-2 and >=-5. Women were not included in the study if they had experienced any vertebral fractures, underwent hip implants, had any gastrointestinal lesions, or had cancer. Funding for this study was supported by F. Hoffman-LaRoche Ltd. and GlaxoSmithKline. [Presentation title: QCT and FEA Assessment of Proximal Femur Bone Quality and Strength in Women With Postmenopausal Osteoporosis Receiving Once-Monthly Oral Ibandronate for 12 Months. Abstract sa509]
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