Abstract
Summary
We have examined the effect of oral monthly ibandronate on distal radius and tibia microarchitecture with high-resolution peripheral quantitative tomography compared with placebo, in women with osteopenia, and found that ibandronate did not significantly affect trabecular bone but improved cortical density and thickness at the tibia.
Methods
We have examined the effect of ibandronate on bone microarchitecture with peripheral high-resolution quantitative computed tomography (HR-pQCT) in a randomized placebo-controlled trial among 148 women with osteopenia. Patients received either oral 150 mg monthly ibandronate or placebo over 24 months. Bone microarchitecture was assessed at baseline, 6, 12, and 24 months, using HR-pQCT at the distal radius and tibia; areal bone mineral density (aBMD) was measured with DXA at the spine, hip, and radius.
Results
At 12 months, there was no significant difference in trabecular bone volume at the radius (the primary end point) between women on ibandronate (10.8 ± 2.5%) and placebo (10.5 ± 2.9%), p = 0.25. There was no significant difference in other radius trabecular and cortical microarchitecture parameters at 12 and 24 months. In contrast, at the tibia, cortical vBMD in the ibandronate group was significantly greater than in the placebo group at 6, 12, and 24 months, with better cortical thickness at 6, 12, and 24 months. With ibandronate, aBMD was significantly increased at the hip and spine at 12 and 24 months but at the radius was significantly superior to placebo only at 24 months. Most of the adverse events related to ibandronate were expected with bisphosphonate use, and none of them were serious.
Conclusion
We conclude that 12 months of treatment with ibandronate in women with osteopenia did not affect trabecular bone microarchitecture, but improved cortical vBMD at the tibia at 12 and 24 months, and preserved cortical thickness at the tibia.
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References
Siris ES, Miller PD, Barrett-Connor E et al (2001) Identification and fracture outcomes of undiagnosed low bone mineral density in postmenopausal women: result from the National Osteoporosis Risk Assessment. JAMA 286:2815–2822
Sornay-Rendu E, Munoz F, Garnero P, Duboeuf F, Delmas PD (2005) Identification of osteopenic women at high risk of fracture: the OFELY study. J Bone Miner Res 16:1184–1192
Boutroy S, Bouxsein ML, Munoz F, Delmas PD (2006) In vivo assessment of trabecular bone microarchitecture by high resolution peripheral quantitative computed tomography. J Clin Endocrinol Metab 90:6508–6515
Majumdar S, Genant HK, Grampp S et al (1997) Correlation, of trabecular bone structure with age, bone mineral density, and osteoporotic status: in vivo studies in the distal radius using high resolution magnetic resonance imaging. J Bone Miner Res 12:111–118
Sornay-Rendu E, Cabrera-Bravo JL, Boutroy S, Munoz F, Delmas PD (2009) Severity of vertebral fractures is associated with alterations of cortical architecture in postmenopausal women. J Bone Miner Res 24:737–743
Sornay-Rendu E, Boutroy S, Munoz F, Delmas PD (2007) Alterations of cortical and trabecular architecture are associated with fractures in postmenopausal women, partially independent of decreased BMD measured by DXA: the OFELY study. J Bone Miner Res 22:425–433
Melton LJ III, Riggs BL, Keaveny TM, Achenbach SJ, Kopperdahl D, Camp JJ, Rouleau PA, Amin S, Atkinson EJ, Robb RA, Therneau TM, Khosla S (2010) Relation of vertebral deformities to bone density, structure and strength. J Bone Miner Res 25:1922–1930
Delmas PD, Seeman E (2004) Changes in bone mineral density explain little of the reduction in vertebral or nonvertebral fracture risk with antiresorptive therapy. Bone 34:599–604
Chapurlat RD, Ramsay P, Palermo L, Cummings SR (2005) Risk of fracture among women who lose bone density during treatment with alendronate. The Fracture Intervention Trial. Osteoporos Int 16:842–848
Gordon CL, Lang TF, Augat P, Genant HK (1998) Image-based assessment of spinal trabecular bone structure from high-resolution CT images. Osteoporos Int 8:317–325
Link TM, Vieth V, Langenberg R et al (2003) Structure analysis of high resolution magnetic resonance imaging of the proximal femur: in vitro correlation with biomechanical strength and BMD. Calcif Tissue Int 72:156–165
Chesnut CH 3rd, Rosen CJ (2003) Reconsidering the effects of antiresorptive therapies in reducing osteoporotic fracture. J Bone Miner Res 16:2163–2172
Riggs BL, Melton LJ 3rd (2002) Bone turnover matters: the raloxifene treatment paradox of dramatic decreases in vertebral fractures without commensurate increases in bone density. J Bone Miner Res 17:11–14
Burghardt AJ, Kazakia GJ, Sode M, de Papp AE, Link TM, Majumdar S (2010) A longitudinal HR-pQCT study of alendronate treatment in postmenopausal women with low bone density: relations among density, cortical and trabecular microarchitecture, biomechanics, and bone turnover. J Bone Miner Res 25:2558–2571
Seeman E, Delmas PD, Hanley DA, Sellmeyer D, Cheung AM, Shane E, Kearns A, Thomas T, Boyd SK, Boutroy S, Bogado C, Majumdar S, Fan M, Libanati C, Zanchetta J (2010) Microarchitectural deterioration of cortical and trabecular bone: differing effects of denosumab and alendronate. J Bone Miner Res 25:1886–1894
Seeman E, Chapurlat R, Cheung A, Felsenberg D, Laroche M, Reeve J, Thomas T, Zanchetta J, Bock O, Morris E, Tile L, D’Alo G, Darbie L, Borah B, Rizzoli R (2010) Risedronate reduces microstructural deterioration of cortical bone accompanying menopause. Osteoporos Int 21(Suppl1):S9
Fuchs RK, Shea M, Durski SL, Winters-Stone KM, Widrick J, Snow CM (2007) Individual and combined effects of exercise and alendronate on bone mass and strength in ovariectomized rats. Bone 41:290–296
Braith RW, Conner JA, Fulton MN, Lisor CF, Casey DP, Howe KS, Baz MA (2007) Comparison of alendronate vs alendronate plus mechanical loading as prophylaxis for osteoporosis in lung transplant recipients: a pilot study. J Heart Lung Transplant 26(2):132–137
Boivin GY, Chavassieux PM, Santora AC, Yates J, Meunier PJ (2000) Alendronate increases bone strength by increasing the mean degree of mineralization of bone tissue in osteoporotic women. Bone 27:687–694
Boyd SK (2008) Site-specific variation of bone micro-architecture in the distal radius and tibia. J Clin Densitom 11:424–430
Davis KA, Burghardt AJ, Link TM, Majumdar S (2007) The effects of geometric and threshold definitions on cortical bone metrics assessed by in vivo high-resolution peripheral quantitative computed tomography. Calcif Tissue Int 81:364–371
Conflicts of interest
The study has been designed collaboratively between the investigators and the sponsor (Roche). The study conduct, data collection, statistical analysis, and funding were the responsibility of the sponsor. The manuscript was drafted by R Chapurlat. All other authors participated in collecting data and critical review of drafts and approved the submitted manuscript. Authors had access to all study data. The decision to submit the manuscript was at the discretion of the authors. Roland Chapurlat has received research funding and/or honoraria from Amgen, Servier, Novartis, Roche, Merck, Lilly, Ipsen, Chugai. Thierry Thomas has received research funding and/or honoraria from Amgen, BMS, Chugai, GSK, Ipsen, Lilly, MSD, Novartis, Roche, Servier, Warner-Chilcott. Stéphanie Rouanet is an employee of Roche. Marie-Christine de Vernejoul and Michel Laroche have no conflict of interest to declare.
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Pierre D. Delmas is deceased.
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Chapurlat, R.D., Laroche, M., Thomas, T. et al. Effect of oral monthly ibandronate on bone microarchitecture in women with osteopenia—a randomized placebo-controlled trial. Osteoporos Int 24, 311–320 (2013). https://doi.org/10.1007/s00198-012-1947-4
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DOI: https://doi.org/10.1007/s00198-012-1947-4