Monthly oral ibandronate therapy in postmenopausal osteoporosis: 1-Year results from the MOBILE study

Journal of Bone and Mineral Research

Volumn 20, Issue 8, 2005, Pages 1315-1322

  Miller, Paul D ^a   McClung, Michael R ^b   Macovei, Liviu ^c   Stakkestad, Jacob A ^d   Luckey, Marjorie ^e   Bonvoisin, Bernard ^f   Reginster, Jean Yves ^g   Recker, Robert R ^h   Hughes, Claire ^f   Lewiecki, E Michael ⁱ   Felsenberg, Dieter ^j   Delmas, Pierre D ^k   Kendler, David L ^l   Bolognese, Michael A ^m   Mairon, Nicole ^f   Cooper, Cyrus ⁿ  

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

^b OREGON OSTEOPOROSIS CENTER   (United States)

^c SANA Medical Center   (Romania)

^d CECOR   (Norway)

^e Saint Barnabas Ambulatory Care Ctr   (United States)

^f F HOFFMANN LA ROCHE LTD   (Switzerland)

^g UNIVERSITY OF LIÈGE   (Belgium)

^h CREIGHTON UNIVERSITY   (United States)

ⁱ NEW MEXICO CLINICAL RESEARCH AND OSTEOPOROSIS CENTER   (United States)

^j CHARITÉ UNIVERSITÄTSMEDIZIN BERLIN   (Germany)

^k UNIVERSITÉ LYON 1   (France)

^l UNIVERSITY OF BRITISH COLUMBIA   (Canada)

^m Bethesda Health Research Center   (United States)

ⁿ UNIVERSITY OF SOUTHAMPTON   (United Kingdom)

more..

Author keywords

Bisphosphonate; Ibandronate; Monthly; Noninferiority; Osteoporosis

Indexed keywords

BIOCHEMICAL MARKER; BISPHOSPHONIC ACID DERIVATIVE; CARBOXY TERMINAL TELOPEPTIDE; IBANDRONIC ACID;

ADULT; AGED; ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; FEMALE; FEVER; FLU LIKE SYNDROME; GASTROINTESTINAL SYMPTOM; HUMAN; MAJOR CLINICAL STUDY; MYALGIA; NAUSEA; PATIENT COMPLIANCE; PHASE 3 CLINICAL TRIAL; POSTMENOPAUSE OSTEOPOROSIS; RANDOMIZED CONTROLLED TRIAL; RISK REDUCTION; SIDE EFFECT; VERTEBRA FRACTURE; WEIGHT GAIN;

EID: 22744433117     PISSN: 08840431     EISSN: None     Source Type: Journal    
DOI: 10.1359/JBMR.050313     Document Type: Article

References (40)

1. International Osteoporosis Foundation 2001 Osteoporosis in the European Community: A Call To Action. International Osteoporosis Foundation, Berne, Switzerland.
2. st century. Am J Med 103:20S-26S.
3. Ray NF, Chan JK, Thamer M, Melton LJ III 1997 Medical expenditures for the treatment of osteoporotic fractures in the United States in 1995; report from the National Osteoporosis Foundation. J Bone Miner Res 12:24-35.
4. Melton LJ, Chrischilles EA, Cooper C, Lane AW, Riggs BL 1992 Perspective. How many women have osteoporosis? J Bone Miner Res 7:1005-1010.
5. Chrischilles EA, Butler CD, Davis CS, Wallace RB 1991 A model of lifetime osteoporosis impact. Arch Intern Med 151:2026-2032.
6. Greendale GA, Barrett-Connor E, Ingles S, Haile R 1995 Late physical and functional effects of osteoporotic fracture in women. The Rancho Bernardo Study. J Am Geriatr Soc 43:955-961.
7. Cooper C, Atkinson EJ, Jacobsen SJ, O'Fallon WM, Melton LJ 1993 Population-based study of survival after osteoporotic fractures. Am J Epidemiol 137:1001-1005.
8. Browner WS, Pressman AR, Nevitt MC, Cunimings SR 1996 Mortality following fractures in older women. The study of osteoporotic fractures. Arch Intern Med 156:1521-1525.
9. Osteoporosis Prevention Diagnosis and Therapy 2000 NIH Consensus Statement. March 27-29, 2000.
10. Chesnut CH III, Skag A, Christiansen C, Recker R, Stakkestad JA, Hoiseth A, Felsenberg D, Huss H, Gilbride J, Schimmer RC, Delmas PD, Oral Ibandronate Osteoporosis Vertebral Fracture Trial in North America and Europe (BONE) 2004 Effects of oral ibandronate administered daily or intermittently on fracture risk in postmenopausal osteoporosis. J Bone Miner Res 19:1241-1249.
11. Reginster J, Minne HW, Sorensen OH, Hooper M, Roux C, Brandi ML, Lund B, Ethgen D, Pack S, Roumagnac I, Eastell R 2000 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 11:83-91.
12. Black DM, Cummings SR, Karpf DB, Cauley JA, Thompson DE, Nevitt MC, Bauer DC, Genant HK, Haskdl WL, Marcus R, Ott SM, Torner JC, Quandt SA, Reiss TF, Ensrud KE 1996 Randomised trial of effect of alendronate on risk of fracture in women with existing vertebral fractures. Fracture Intervention Trial Research Group. Lancet 348:1535-1541.
13. Harris ST, Watts NB, Genant HK, McKeever CD, Hangartner T, Keller M, Chesnut CH III, Brown J, Eriksen EF, Hoseyni MS, Axelrod DW, Miller PD 1999 Effects of risedronate treatment on vertebral and nonvertebral fractures in women with postmenopausal osteoporosis: A randomized controlled trial. Vertebral Efficacy with Risedronate Therapy (VERT) Study Group. JAMA 282:1344-1352.
14. McClung MR, Geusens P, Miller PD, Zippel FJ, Bensen WG, Roux C, Adami S, Fogelman I, Diamond T, Eastell R, Meunier PJ, Reginster JY; Hip Intervention Program Study Group 2001 Effect of risedronate on the risk of hip fracture in elderly women. Hip Intervention Program Study Group. N Engl J Med 344:333-340.
15. Sambrook PN, Rodriguez JP, Wasnich RD, Luckey MM, Kaur A, Meng L, Lombardi A 2004 Alendronate in the prevention of osteoporosis: 7-year follow-up. Osteoporos Int 15:483-488.
16. Bone HG, Hosking D, Devogelaer JP, Tucci JR, Emkey RD, Tonino RP, Rodriguez-Portales JA, Downs RW, Gupta J, Santora AC, Liberman UA 2004 Ten years' experience with alendronate for osteoporosis in postmenopausal women. N Engl J Med 350:1189-1199.
17. Sorensen OH, Crawford GM, Mulder H, Hosking DJ, Gennari C, Mellstrom D, Pack S, Wenderoth D, Cooper C, Reginster JY 2003 Long-term efficacy of risedronate: A 5-year placebo-controlled clinical experience. Bone 32:120-126.
18. Cramer JA, Amonkar MM, Hebborn A, Suppapanya N Alendronate Phase III Osteoporosis Treatment Study Group 2004 Does dosing regimen impact persistence with bisphosphonate therapy among postmenopausal osteoporotic women? J Bone Miner Res 19:S1;S448.
19. Recker RR, Gallagher R, Amonkar M, Smith JC, MacCosbe PE 2004 Medication persistence is better with weekly bisphosphonates, but it remains suboptimal. J Bone Miner Res 19:S1;S172.
20. Papaioannou A, Ioannidis G, Adachi JD, Sebaldt RJ, Ferko N, Puglia M, Brown J, Tenenhouse A, Olszynski WP, Boulos P, Hanley DA, Josse R, Murray TM, Petrie A, Goldsmith CH 2003 Adherence to bisphosphonate hormone replacement therapy in a tertiary care setting of patients in the CANDOO database. Osteoporos Int 14:808-813.
21. Caro JJ, Ishak KJ, Huybrechts KF, Raggio G, Naujoks C 2004 The impact of compliance with osteoporosis therapy on fracture rates in actual practice. Osteoporos Int 15:1003-1008.
22. Yood RA, Emani S, Reed JI, Lewis BE, Charpentier M, Lydick E 2003 Compliance with pharmacologic therapy for osteoporosis. Osteoporos Int 14:965-968.
23. Clowes JA, Peel NFA, Eastell R 2004 The impact of monitoring adherence and persistence with antiresorptive treatment for postmenopausal osteoporosis: A randomized controlled trial. J Clin Endocrinol Metab 89:1117-1123.
24. McCombs JS, Thiebaud P, McLaughlin-Miley C, Shi J 2004 Compliance with drug therapies for the treatment and prevention of osteoporosis. Maturitas 48:271-287.
25. Venturini F, Nichol MB, Sung JC, Bailey KL, Cody M, McCombs JS 1999 Compliance with sulphonylureas in a health maintenance organization: A pharmacy record-based study. Ann Pharmacother 33:281-288.
26. Claxton AJ, Cramer J, Pierce C 2001 A systematic review of the associations between dose regimens and medication compliance. Clin Ther 8:1296-1310.
27. Paes AH, Bakker A, Soe-Agnie CJ 1997 Impact of dosing frequency on patient compliance. Diabetes Care 20:1512-1517.
28. Mühlbauer RC, Bauss F, Schenk R, Janner M, Bosies E, Strein K, Fleisch H 1991 BM 21.0955, a potent new bisphosphonate to inhibit bone resorption. J Bone Miner Res 6:1003-1011.
29. Bauss F, Russell RGG 2004 Ibandronate in osteoporosis: Preclinical data and rationale for intermittent dosing. Osteoporos Int 15:423-433.
30. Reginster J-Y, Wiese C, Wilson K, Schimmer RC 2003 Oral monthly ibandronate decreases bone turnover in postmenopausal women with low bone mass: Results from the Monthly Oral Pilot Study (MOPS). Osteoporos Int 14(Suppl 7):S5.
31. Wasnich RD, Miller PD 2000 Antifracture efficacy of antiresorptive agents are related to changes in bone density. J Clin Endocrinol Metab 85:231-236.
32. Hochberg MC, Greenspan S, Wasnich RD, Miller P, Thompson DE, Ross PD 2002 Changes in bone density and turnover explain the reductions in incidence of nonvertebral fractures that occur during treatment with antiresorptive agents. J Clin Endocrinol Metab 87:1586-1592.
33. ICH Harmonized Tripartite Guideline 1999 Statistical principles for clinical trials. Stat Med 18:1905-1942.
34. Brown JP, Kendler DL, McClung MR, Emkey RD, Adachi JD, Bolognese MA, Li Z, Balske A, Lindsay R 2002 The efficacy and tolerability of risedronate once a week for the treatment of postmenopausal osteoporosis. Calcif Tissue Int 71:103-111.
35. Riis BJ, Ise J, Von Stein T, Bagger Y, Christiansen C 2001 Ibandronate: A comparison of oral daily dosing versus intermittent dosing in postmenopausal osteoporosis. J Bone Miner Res 16:1871-1878.
36. Ravn P, Clemmesen B, Riis BJ, Christiansen C 1996 The effect on bone mass and bone markers of different doses of ibandronate: A new bisphosphonate for prevention and treatment of postmenopausal osteoporosis: A 1 year, randomised, double-blind, placebo controlled dose finding study. Bone 19:527-533.
37. Merck & Co., Inc. 2004 Alendronate prescribing information. Available online at http://www.fosamax.com. Accessed December 2004.
38. Procter & Gamble Pharmaceuticals 2003 Risedronate prescribing information. Available online at http://www.actonel.com. Accessed December 2004.
39. Schnitzer T, Bone HG, Crepaldi G, Adami S, McClung M, Kiel D, Felsenberg D, Recker RR, Tonino RP, Roux C, Pinchera A, Foldes AJ, Greenspan SL, Levine MA, Emkey R, Santora AC II, Kaur A, Thompson DE, Yates J, Orloff JJ 2000 Therapeutic equivalence of alendronate 70 mg once-weekly and alendronate 10 mg daily in the treatment of osteoporosis. Alendronate Once-Weekly Study Group. Aging (Milano) 12:1-12.
40. Rizzoli R, Greenspan SL, Bone G III, Schnitzer TJ, Watts NB, Adami S, Foldes AJ, Roux C, Levine MA, Uebelhart B, Santora AC II, Kaur A, Peverly CA, Orloff JJ, Alendronate Once-Weekly Study Group 2002 Two-year results of once weekly administration of alendronate 70 mg for the treatment of postmenopausal osteoporosis. J Bone Miner Res 17:1988-1996.