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New Mexico Clinical Research & Osteoporosis Center (E.M.L.), Albuquerque, New Mexico 87106; University of California, Berkeley (T.M.K.), Berkeley, California 94720; O. N. Diagnostics (T.M.K., D.L.K.), Berkeley, California 94704; University of California, San Francisco (H.K.G.), San Francisco, California 94143; Synarc, Inc. (H.K.G., T.F.), San Francisco, California 94105; Synarc, Inc., 22087 Hamburg, Germany, and Institute of Medical Physics, University of Erlangen (K.E.), 91054 Erlangen, Germany; Altoona Arthritis and Osteoporosis Center (A.K.), Duncansville, Pennsylvania 16635; and GlaxoSmithKline (R.Y.D., L.A.F.), King of Prussia, Pennsylvania 19406
Address all correspondence & requests for reprints to: E. Michael Lewiecki, M.D., F.A.C.P., F.A.C.E., Osteoporosis Director, New Mexico Clinical Research & Osteoporosis Center, 300 Oak Street NE, Albuquerque, New Mexico 87106. E-mail: lewiecki{at}aol.com.
Context: Bone strength and fracture resistance are determined by bone mineral density (BMD) and structural, mechanical, and geometric properties of bone.
Design, Setting, and Objectives: This randomized, double-blind, placebo-controlled outpatient study evaluated effects of once-monthly oral ibandronate on hip and lumbar spine BMD and calculated strength using quantitative computed tomography (QCT) with finite element analysis (FEA) and dual-energy x-ray absorptiometry (DXA) with hip structural analysis (HSA).
Participants: Participants were women aged 55–80 yr with BMD T-scores –2.0 or less to –5.0 or greater (n = 93).
Intervention: Oral ibandronate 150 mg/month (n = 47) or placebo (n = 46) was administered for 12 months.
Outcome Measures: The primary end point was total hip QCT BMD change from baseline; secondary end points included other QCT BMD sites, FEA, DXA, areal BMD, and HSA. All analyses were exploratory, with post hoc P values.
Results: Ibandronate increased integral total hip QCT BMD and DXA areal BMD more than placebo at 12 months (treatment differences: 2.2%, P = 0.005; 2.0%, P = 0.003). FEA-derived hip strength to density ratio and femoral, peripheral, and trabecular strength increased with ibandronate vs. placebo (treatment differences: 4.1%, P < 0.001; 5.9%, P < 0.001; 2.5%, P = 0.011; 3.5%, P = 0.003, respectively). Ibandronate improved vertebral, peripheral, and trabecular strength and anteroposterior bending stiffness vs. placebo [7.1% (P < 0.001), 7.8% (P < 0.001), 5.6% (P = 0.023), and 6.3% (P < 0.001), respectively]. HSA-estimated femoral narrow neck cross-sectional area and moment of inertia and outer diameter increased with ibandronate vs. placebo (respectively 3.6%, P = 0.003; 4.0%, P = 0.052; 2.2%, P = 0.049).
Conclusions: Once-monthly oral Ibandronate for 12 months improved hip and spine BMD measured by QCT and DXA and strength estimated by FEA of QCT scans.
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