Efficacy and safety of monthly ibandronate in men with low bone density

Bone

Volumn 46, Issue 4, 2010, Pages 970-976

  Orwoll, Eric S ^a   Binkley, Neil C ^b   Lewiecki, E Michael ^c   Gruntmanis, Ugis ^d   Fries, Michael A ^e   Dasic, Gorana ^e  

^a OREGON HEALTH AND SCIENCE UNIVERSITY   (United States)

^b UNIVERSITY OF WISCONSIN MADISON   (United States)

^c NEW MEXICO CLINICAL RESEARCH AND OSTEOPOROSIS CENTER   (United States)

^d UNIVERSITY OF TEXAS SOUTHWESTERN MEDICAL CENTER   (United States)

^e GLAXOSMITHKLINE   (United States)

Author keywords

Bone density; Ibandronate; Men; Osteoporosis; Treatment

Indexed keywords

ALKALINE PHOSPHATASE BONE ISOENZYME; CALCIUM CARBONATE; CARBOXY TERMINAL TELOPEPTIDE; IBANDRONIC ACID; PLACEBO; TESTOSTERONE; VITAMIN D;

ADULT; AGED; ARTHRALGIA; ARTICLE; BACKACHE; BONE DENSITY; BONE TURNOVER; CLINICAL TRIAL; CONSTIPATION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG INDICATION; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; DUAL ENERGY X RAY ABSORPTIOMETRY; FEMUR NECK; FEVER; FLU LIKE SYNDROME; FRACTURE; HEADACHE; HUMAN; HYPOGONADISM; LIMB PAIN; LUMBAR SPINE; MAJOR CLINICAL STUDY; MALE; NAUSEA; OSSIFICATION; OSTEOLYSIS; OSTEOPOROSIS; PATIENT COMPLIANCE; RANDOMIZED CONTROLLED TRIAL; RHINOPHARYNGITIS; SCORING SYSTEM; TREATMENT DURATION; TREATMENT OUTCOME; UPPER RESPIRATORY TRACT INFECTION; VERTEBRA FRACTURE;

ABSORPTIOMETRY, PHOTON; AGED; ALKALINE PHOSPHATASE; BIOLOGICAL MARKERS; BONE DENSITY; BONE DENSITY CONSERVATION AGENTS; COLLAGEN TYPE I; DIPHOSPHONATES; DOUBLE-BLIND METHOD; DRUG ADMINISTRATION SCHEDULE; HUMANS; INTENTION TO TREAT ANALYSIS; MALE; MIDDLE AGED; OSTEOPOROSIS; PEPTIDES; TREATMENT OUTCOME;

EID: 77950545056     PISSN: 87563282     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.bone.2009.12.034     Document Type: Article

References (32)

1. Khosla S., Amin S., Orwoll E. Osteoporosis in men. Endocr. Rev. 2008, 29:441-464.
2. National Osteoporosis Foundation. Fast Facts on Osteoporosis. Available at: Accessed September 8, 2009. http://www.nof.org/osteoporosis/diseasefacts.htm#top.
3. Eastell R., Boyle I.T., Compston J., Cooper C., Fogelman I., Francis R.M., et al. Management of male osteoporosis: report of the UK Consensus Group. QJM 1998, 91:71-92.
4. Center J.R., Nguyen T.V., Schneider D., Sambrook P.N., Eisman J.A. Mortality after all major types of osteoporotic fracture in men and women: an observational study. Lancet 1999, 353:878-882.
5. Johnell O., Haglund B. Co-morbidity and mortality in hip fracture patients: a population-based study. J. Bone. Miner. Res. 1999, 14:1109.
6. Schuit S.C., van der Klift M., Weel A.E., de Laet C.E., Burger H., Seeman E., et al. Fracture incidence and association with bone mineral density in elderly men and women: the Rotterdam Study. Bone 2004, 34:195-202.
7. Cummings S.R., Cawthon P.M., Ensrud K.E., Cauley J.A., Fink H.A., Orwoll E.S. BMD and risk of hip and nonvertebral fractures in older men: a prospective study and comparison with older women. J. Bone Miner. Res. 2006, 21:1550-1556.
8. Briot K., Cortet B., Tremollieres F., Sutter B., Thomas T., Roux C., et al. Male osteoporosis: diagnosis and fracture risk evaluation. Joint Bone Spine 2009, 76:122-129.
9. Cawthon P.M., Ewing S.K., McCulloch C.E., Ensrud K.E., Cauley J.A., Cummings S.R., et al. Loss of hip bone mineral density in older men: the Osteoporotic Fractures in Men (MrOS) Study. J. Bone Miner. Res. 2009, 24:1728-1735.
10. Black D.M., Delmas P.D., Eastell R., Reid I.R., Boonen S., Cauley J.A., et al. Once-yearly zoledronic acid for treatment of postmenopausal osteoporosis. N. Engl. J. Med. 2007, 356:1809-1822.
11. 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. 2005, 21:391-401.
12. Cummings S.R., Black D.M., Thompson D.E., Applegate W.B., Barrett-Connor E., Musliner T.A., et al. Effect of alendronate on risk of fracture in women with low bone density but without vertebral fractures: results from the Fracture Intervention Trial. JAMA 1998, 280:2077-2082.
13. Reginster J., Minne H.W., Sorensen O.H., Hooper M., Roux C., Brandi M.L., et al. Randomized trial of the effects of risedronate on vertebral fractures in women with established postmenopausal osteoporosis. Vertebral Efficacy with Risedronate Therapy (VERT) Study Group. Osteoporos. Int. 2000, 11:83-91.
14. Reclast Prescribing Information. Novartis Pharma Stein AG; Stein, Switzerland. Available at: Accessed September 8, 2009. http://www.pharma.us.novartis.com/product/pi/pdf/reclast.pdf.
15. Actonel (risedronate sodium tablets) US Prescribing Information. Procter and Gamble Pharmaceuticals; Cincinnati, OH. Available at: Accessed September 8, 2009. https://www.actonel.com/global/prescribing_information.pdf.
16. Fosamax (alendronate sodium) US Prescribing Information. Merck and Co., Inc.; Whitehouse Station, NJ. Available at: Accessed September 8, 2009. http://www.merck.com/product/usa/pi_circulars/f/fosamax/fosamax_pi.pdf.
17. 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. 2006, 65:654-661.
18. Barrett J., Worth E., Bauss F., Epstein S. Ibandronate: a clinical pharmacological and pharmacokinetic update. J. Clin. Pharmacol. 2004, 44:951-965.
19. Boniva (ibandronate sodium) US Prescribing Information. Roche Laboratories Inc.; Nutley, NJ. Available at: Accessed September 8, 2009. http://www.rocheusa.com/products/Boniva/PI.pdf.
20. Snyder P.J., Peachey H., Berlin J.A., Hannoush P., Haddad G., Dlewati A., et al. Effects of testosterone replacement in hypogonadal men. J. Clin. Endocrinol. Metab. 2000, 85:2670-2677.
21. 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. 2005, 20:1315-1322.
22. Miller P.D., Epstein S., Sedarati F., Reginster J.Y. Once-monthly oral ibandronate compared with weekly oral alendronate in postmenopausal osteoporosis: results from the head-to-head MOTION study. Curr. Med. Res. Opin. 2008, 24:207-213.
23. McClung M.R., Bolognese M.A., Sedarati F., Recker R.R., Miller P.D. Efficacy and safety of monthly oral ibandronate in the prevention of postmenopausal bone loss. Bone 2009, 44:418-422.
24. Dawson-Hughes B., Harris S.S., Krall E.A., Dallal G.E. Effect of calcium and vitamin D supplementation on bone density in men and women 65 years of age or older. N. Engl. J. Med. 1997, 337:670-676.
25. Orwoll E., Ettinger M., Weiss S., Miller P., Kendler D., Graham J., et al. Alendronate for the treatment of osteoporosis in men. N. Engl. J. Med. 2000, 343:604-610.
26. Ringe J.D., Faber H., Dorst A. Alendronate treatment of established primary osteoporosis in men: results of a 2-year prospective study. J. Clin. Endocrinol. Metab. 2001, 86:5252-5255.
27. Lamy O., Sandini L., Pache I., Fatio S., Burnand J., Burckhardt P. Intravenous ibandronate in men with osteoporosis: an open pilot study over 2 years. J. Endocrinol. Invest. 2003, 26:728-732.
28. Stepan J.J., Burckhardt P., Hana V. The effects of three-month intravenous ibandronate on bone mineral density and bone remodeling in Klinefelter's syndrome: the influence of vitamin D deficiency and hormonal status. Bone 2003, 33:589-596.
29. Boonen S., Orwoll E.S., Wenderoth D., Stoner K.J., Eusebio R., Delmas P.D. Once-weekly risedronate in men with osteoporosis: results of a 2-year, placebo-controlled, double-blind, multicenter study. J. Bone Miner. Res. 2009, 24:719-725.
30. Ringe J.D., Dorst A., Faber H., Ibach K. Alendronate treatment of established primary osteoporosis in men: 3-year results of a prospective, comparative, two-arm study. Rheumatol. Int. 2004, 24:110-113.
31. Ringe J.D., Farahmand P., Faber H., Dorst A. Sustained efficacy of risedronate in men with primary and secondary osteoporosis: results of a 2-year study. Rheumatol. Int. 2009, 29:311-315.
32. Miller P., Orwoll E., Vandormael K., MacIntyre B., Smith M., Vandormael K., et al. Treatment with alendronate 70-mg once weekly for 12 months increases bone mineral density and decreases biochemical markers of bone turnover in men with osteoporosis. 2nd International Conference on Osteoporosis in Men. Genoa, Italy: Springer-Verlag London Ltd 2003, P4.