Efficacy and safety of monthly oral ibandronate in the prevention of postmenopausal bone loss

Bone

Volumn 44, Issue 3, 2009, Pages 418-422

  McClung, Michael R ^a   Bolognese, Michael A ^b   Sedarati, Farhad ^c   Recker, Robert R ^d   Miller, Paul D ^e  

^a OREGON OSTEOPOROSIS CENTER   (United States)

^b Bethesda Health Research   (United States)

^c HOFFMANN LA ROCHE INC   (United States)

^d CREIGHTON UNIVERSITY SCHOOL OF MEDICINE   (United States)

^e University of Colorado Health Sciences Center   (United States)

Author keywords

Bisphosphonates; Bone mineral density; Ibandronate; Low bone mass; Osteoporosis; Postmenopausal women

Indexed keywords

CALCIUM; IBANDRONIC ACID; VITAMIN D;

ADULT; ARTHRALGIA; ARTICLE; BONE MASS; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; DRUG WITHDRAWAL; DYSPEPSIA; FEMALE; FEMUR NECK; FLU LIKE SYNDROME; FRACTURE; GASTROESOPHAGEAL REFLUX; HUMAN; MAJOR CLINICAL STUDY; MYALGIA; NAUSEA; OSTEOLYSIS; OSTEOPOROSIS; POSTMENOPAUSE; RANDOMIZED CONTROLLED TRIAL;

ADMINISTRATION, ORAL; BONE DENSITY; BONE DENSITY CONSERVATION AGENTS; DIPHOSPHONATES; DOUBLE-BLIND METHOD; DRUG ADMINISTRATION SCHEDULE; FEMALE; HUMANS; MIDDLE AGED; OSTEOPOROSIS, POSTMENOPAUSAL; PLACEBOS; TREATMENT OUTCOME;

EID: 59649112092     PISSN: 87563282     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.bone.2008.09.011     Document Type: Article

References (30)

1. World Health Organization. Assessment of fracture risk and its application to screening for postmenopausal osteoporosis. Report of a WHO Study Group. Geneva: World Health Organization. 1994. World Health Organ Tech Rep Ser 843.
2. Melton III L.J., Atkinson E.J., O'Fallon W.M., Wahner H.W., and Riggs B.L. Long-term fracture prediction by bone mineral assessed at different skeletal sites. J. Bone Miner. Res. 8 (1993) 1227-1233
3. Kanis J.A., Johnell O., Oden A., Dawson A., De Laet C., and Jonsson B. Ten year probabilities of osteoporotic fractures according to BMD and diagnostic thresholds. Osteoporos. Int. 12 (2001) 989-995
4. National Osteoporosis Foundation. America's Bone Health: the state of osteoporosis and low bone mass in our nation (2002), National Osteoporosis Foundation, Washington DC
5. Siris E.S., Miller P.D., Barrett-Connor E., Faulkner K.G., Wehren L.E., Abbott T.A., et al. Identification and fracture outcomes of undiagnosed low bone mineral density in postmenopausal women: results from the National Osteoporosis Risk Assessment. JAMA 286 (2001) 2815-2822
6. Sornay-Rendu E., Munoz F., Garnero P., Duboeuf F., and Delmas P.D. Identification of osteopenic women at high risk of fracture: the OFELY study. J. Bone Miner. Res. 20 (2005) 1813-1819
7. Pasco J.A., Seeman E., Henry M.J., Merriman E.N., Nicholson G.C., and Kotowicz M.A. The population burden of fractures originates in women with osteopenia, not osteoporosis. Osteoporos. Int. 17 (2006) 1404-1409
8. McClung M.R., Wasnich R.D., Hosking D.J., Christiansen C., Ravn P., Wu M., et al. Prevention of postmenopausal bone loss: six-year results from the Early Postmenopausal Intervention Cohort Study. J. Clin. Endocrinol. Metab. 89 (2004) 4879-4885
9. Luckey M.M., Gilchrist N., Bone H.G., Davie M.W., de Villiers T.J., Wu M., et al. Therapeutic equivalence of alendronate 35 milligrams once weekly and 5 milligrams daily in the prevention of postmenopausal osteoporosis. Obstet. Gynecol. 101 (2003) 711-721
10. Valimaki M.J., Farrerons-Minguella J., Halse J., Kroger H., Maroni M., Mulder H., et al. Effects of risedronate 5 mg/d on bone mineral density and bone turnover markers in late-postmenopausal women with osteopenia: a multinational, 24-month, randomized, double-blind, placebo-controlled, parallel-group, phase III trial. Clin. Ther. 29 (2007) 1937-1949
11. Fogelman I., Ribot C., Smith R., Ethgen D., Sod E., and Reginster J.Y. Risedronate reverses bone loss in postmenopausal women with low bone mass: results from a multinational, double-blind, placebo-controlled trial. BMD-MN Study Group. J. Clin. Endocrinol. Metab. 85 (2000) 1895-1900
12. McClung M.R., Wasnich R.D., Recker R., Cauley J.A., Chesnut III C.H., Ensrud K.E., et al. Oral daily ibandronate prevents bone loss in early postmenopausal women without osteoporosis. J. Bone Miner. Res. 19 (2004) 11-18
13. Miller P.D., McClung M.R., Macovei L., Stakkestad J.A., Luckey M., Bonvoisin B., et al. Monthly oral ibandronate therapy in postmenopausal osteoporosis: 1-year results from the MOBILE study. J. Bone Miner. Res. 20 (2005) 1315-1322
14. Reginster J.Y., Adami S., Lakatos P., Greenwald M., Stepan J.J., Silverman S.L., et al. Efficacy and tolerability of once-monthly oral ibandronate in postmenopausal osteoporosis: 2 year results from the MOBILE study. Ann. Rheum. Dis. 65 (2006) 654-661
15. Chesnut C.H., Ettinger M.P., Miller P.D., Baylink D.J., Emkey R., Harris S.T., et al. Ibandronate produces significant, similar antifracture efficacy in North American and European women: new clinical findings from BONE. Curr. Med. Res. Opin. 21 (2005) 391-401
16. Lenora J., Ivaska K.K., Obrant K.J., and Gerdhem P. Prediction of bone loss using biochemical markers of bone turnover. Osteoporos. Int. 18 (2007) 1297-1305
17. Garnero P., Munoz F., Sornay-Rendu E., and Delmas P.D. Associations of vitamin D status with bone mineral density, bone turnover, bone loss and fracture risk in healthy postmenopausal women. The OFELY study. Bone 40 (2007) 716-722
18. Cummings S.R., Black D.M., Nevitt M.C., Browner W., Cauley J., Ensrud K., et al. Bone density at various sites for prediction of hip fractures. The Study of Osteoporotic Fractures Research Group. Lancet 341 (1993) 72-75
19. Kanis J.A., Borgstrom F., De Laet C., Johansson H., Johnell O., Jonsson B., et al. Assessment of fracture risk. Osteoporos. Int. 16 (2005) 581-589
20. Dufresne T.E., Chmielewski P.A., Manhart M.D., Johnson T.D., and Borah B. Risedronate preserves bone architecture in early postmenopausal women in 1 year as measured by three-dimensional microcomputed tomography. Calcif. Tissue Int. 73 (2003) 423-432
21. McClung M.R. Osteopenia: to treat or not to treat?. Ann. Intern. Med. 142 (2005) 796-797
22. Watts N.B. What is osteopenia, and what should be done about it?. Cleve. Clin. J. Med. 73 (2006) 29-32
23. Khosla S., and Melton III L.J. Clinical practice. Osteopenia. N. Engl. J. Med. 356 (2007) 2293-2300
24. Schousboe J.T., Nyman J.A., Kane R.L., and Ensrud K.E. Cost-effectiveness of alendronate therapy for osteopenic postmenopausal women. Ann. Intern. Med. 142 (2005) 734-741
25. Meadows E.S., Klein R., Rousculp M.D., Smolen L., Ohsfeldt R.L., and Johnston J.A. Cost-effectiveness of preventative therapies for postmenopausal women with osteopenia. BMC Women's Health 7 (2007) 6
26. Chen Y.T., Miller P.D., Barrett-Connor E., Weiss T.W., Sajjan S.G., and Siris E.S. An approach for identifying postmenopausal women age 50-64 years at increased short-term risk for osteoporotic fracture. Osteoporos. Int. 18 (2007) 1287-1296
27. Simon J.A. Does osteopenia warrant treatment?. Menopause 12 (2005) 639-648
28. Siris E.S., Chen Y.T., Abbott T.A., Barrett-Connor E., Miller P.D., Wehren L.E., et al. Bone mineral density thresholds for pharmacological intervention to prevent fractures. Arch. Intern. Med. 164 (2004) 1108-1112
29. National Osteoporosis Foundation. Physician's guide to prevention and treatment of osteoporosis. 2008. Available at: http://www.nof.org/physguide/Physicians_Guide.pdf. Accessed March 4, 2008.
30. World Health Organization. FRAX™ WHO Fracture Risk Assessment Tool 2008. Available at: http://www.shef.ac.uk/FRAX. Accessed March 11, 2007.