Intravenous ibandronate injections in postmenopausal women with osteoporosis: One-year results from the dosing intravenous administration study

Arthritis and Rheumatism

Volumn 54, Issue 6, 2006, Pages 1838-1846

  Delmas, Pierre D ^a,o   Adami, Silvano ^b   Strugala, Cezary ^c   Stakkestad, Jacob A ^d   Reginster, Jean Yves ^e   Felsenberg, Dieter ^f   Christiansen, Claus ^g   Civitelli, Roberto ^h   Drezner, Marc K ⁱ   Recker, Robert R ^j   Bolognese, Michael ^k   Hughes, Claire ^l   Masanauskaite, Daiva ^l   Ward, Penelope ^l   Sambrook, Philip ^m   Reid, David M ⁿ  

^a UNIVERSITÉ LYON 1   (France)

^b UNIVERSITY OF VERONA   (Italy)

^c NZOZ GCP Dobra Praktyka Lekarska ^*  (Poland)

^d CECOR AS   (Norway)

^e UNIVERSITY OF LIÈGE   (Belgium)

^f CHARITÉ UNIVERSITÄTSMEDIZIN BERLIN   (Germany)

^g CENTER FOR CLINICAL AND BASIC RESEARCH   (Denmark)

^h WASHINGTON UNIVERSITY SCHOOL OF MEDICINE   (United States)

ⁱ UNIVERSITY OF WISCONSIN MADISON   (United States)

^j CREIGHTON UNIVERSITY   (United States)

^k Bethesda Health Research   (United States)

^l F HOFFMANN LA ROCHE LTD   (Switzerland)

^m UNIVERSITY OF SYDNEY   (Australia)

ⁿ UNIVERSITY OF ABERDEEN   (United Kingdom)

^o EDOUARD HERRIOT HOSPITAL   (France)

more..

Author keywords

[No Author keywords available]

Indexed keywords

BISPHOSPHONIC ACID DERIVATIVE; CALCIUM; CARBOXY TERMINAL TELOPEPTIDE; COLLAGEN TYPE 1; IBANDRONIC ACID; VITAMIN D;

ADULT; AGED; ARTHRALGIA; ARTICLE; BONE DENSITY; CALCIUM INTAKE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG INTERMITTENT THERAPY; DRUG TOLERABILITY; DYSPEPSIA; FEMALE; FLU LIKE SYNDROME; FRACTURE; GASTROINTESTINAL SYMPTOM; HUMAN; KIDNEY DISEASE; KIDNEY FUNCTION; LUMBAR SPINE; MAJOR CLINICAL STUDY; OSTEOPOROSIS; PHASE 3 CLINICAL TRIAL; POSTMENOPAUSE; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; UPPER ABDOMINAL PAIN; VITAMIN INTAKE;

ADMINISTRATION, ORAL; AGED; AGED, 80 AND OVER; BONE DENSITY; BONE DENSITY CONSERVATION AGENTS; CALCIUM; COLLAGEN TYPE I; DIPHOSPHONATES; DOUBLE-BLIND METHOD; FEMALE; HUMANS; INJECTIONS, INTRAVENOUS; MIDDLE AGED; OSTEOPOROSIS, POSTMENOPAUSAL; PEPTIDES; VITAMIN D;

EID: 33745034449     PISSN: 00043591     EISSN: None     Source Type: Journal    
DOI: 10.1002/art.21918     Document Type: Article

References (27)

1. Chesnut CH III, Skag A, Christiansen C, Recker R, Stakkestad JA, Hoiseth A, et al. Effects of oral ibandronate administered daily or intermittently on fracture risk in postmenopausal osteoporosis. J Bone Miner Res 2004;19:1241-9.
2. Delmas PD, Recker RR, Chesnut CH 3rd, Skag A, Stakkestad JA, Emkey R, et al. Daily and intermittent oral ibandronate normalize bone turnover and provide significant reduction in vertebral fracture risk: results from the BONE study. Osteoporos Int 2004;15:792-8.
3. Reginster J, Minne HW, Sorensen OH, Hooper M, Roux C, Brandi ML, et al, and the Vertebral Efficacy with Risedronate Therapy (VERT) Study Group. Randomized trial of the effects of risedronate on vertebral fractures in women with established postmenopausal osteoporosis. Osteoporos Int 2000;11:83-91.
4. Black DM, Cummings SR, Karpf DB, Cauley JA, Thompson DE, Nevitt MC, et al, and the Fracture Intervention Trial Research Group. Randomised trial of effect of alendronate on risk of fracture in women with existing vertebral fractures. Lancet 1996; 348:1535-41.
5. Harris ST, Watts NB, Genant HK, McKeever CD, Hangartner T, Keller M, et al, and the Vertebral Efficacy With Risedronate Therapy (VERT) Study Group. Effects of risedronate treatment on vertebral and nonvertebral fractures in women with postmenopausal osteoporosis: a randomized controlled trial. JAMA 1999; 282:1344-52.
6. McClung MR, Geusens P, Miller PD, Zippel H, Bensen WG, Roux C, et al, and the Hip Intervention Program Study Group. Effect of risedronate on the risk of hip fracture in elderly women. N Engl J Med 2001;344:333-40.
7. Bone HG, Hosking D, Devogelaer JP, Tucci JR, Emkey RD, Tonino RP, et al. Ten years' experience with alendronate for osteoporosis in postmenopausal women. N Engl J Med 2004;350: 1189-99.
8. Sambrook PN, Rodriguez JP, Wasnich RD, Luckey MM, Kaur A, Meng L, et al. Alendronate in the prevention of osteoporosis: 7-year follow-up. Osteoporos Int 2004;15:483-8.
9. Ste-Marie LG, Sod E, Johnson T, Chines A. Five years of treatment with risedronate and its effects on bone safety in women with postmenopausal osteoporosis. Calcif Tissue Int 2004:75: 469-76.
10. Muhlbauer RC, Bauss F, Schenk R, Janner M, Bosies E, Strein K, et al. BM 21.0955, a potent new bisphosphonate to inhibit bone resorption. J Bone Miner Res 1991;6:1003-10.
11. Bauss F, Russell RG. Ibandronate in osteoporosis: preclinical data and rationale for intermittent dosing. Osteoporos Int 2004;15: 423-33.
12. Felsenberg D, Miller P, Armbrecht G, Wilson K, Schimmer RC, Papapoulos SE. Oral ibandronate significantly reduces the risk of vertebral fractures of greater severity after 1, 2, and 3 years in postmenopausal women with osteoporosis. Bone 2005;37:651-4.
13. Miller PD, McClung MR, Macovei L, Stakkestad JA, 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;20:1315-22.
14. Thiebaud D, Burckhardt P, Kriegbaum H, Huss H, Mulder H, Juttmann JR, et al. Three-monthly intravenous injections of ibandronate in the treatment of postmenopausal osteoporosis. Am J Med 1997;103:298-307.
15. Adami S, Felsenberg D, Christiansen C, Robinson J, Lorenc RS, Mahoney P, et al. Efficacy and safety of ibandronate given by intravenous injection once every 3 months. Bone 2004;34:881-9.
16. Ringe JD, Dorst A, Faber H, Ibach K, Sorenson F. Intermittent intravenous ibandronate injections reduce vertebral fracture risk in corticosteroid-induced osteoporosis: results from a long-term comparative study. Osteoporos Int 2003;14:801-7.
17. Cockcroft DW, Gault MH. Prediction of creatinine clearance from serum creatinine. Nephron 1976;16:31-41.
18. International Conference on Harmonization Expert Working Group. Statistical principles for clinical trials: ICH harmonized tripartite guideline. Statist Med 1999;18:1905-42.
19. Ravn P, Clemmesen B, Riis BJ, Christiansen C. 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 1996;19:527-33.
20. Riis BJ, Ise J, von Stein T, Bagger Y, Christiansen C. Ibandronate: a comparison of oral daily dosing versus intermittent dosing in postmenopausal osteoporosis. J Bone Miner Res 2001;16:1871-8.
21. Recker R, Stakkestad JA, Chesnut CH 3rd, Christiansen C, Skag A, Hoiseth A, et al. Insufficiently dosed intravenous ibandronate injections are associated with suboptimal antifracture efficacy in postmenopausal osteoporosis. Bone 2004;34:890-9.
22. Bounameaux HM, Schifferli J, Montani J-P, Jung A, Chatelanat F. Renal failure associated with intravenous diphosphonates [letter]. Lancet 1983;1:471.
23. Rosen LS, Gordon D, Kaminski M, Howell A, Belch A, Mackey J, et al. Zoledronic acid versus pamidronate in the treatment of skeletal metastases in patients with breast cancer or osteolytic lesions of multiple myeloma: a phase III, double-blind, comparative trial. Cancer J 2001;7:377-87.
24. Markowitz GS, Fine PL, Stack JI, Kunis CL, Radhakrishnan J, Palecki W, et al. Toxic acute tubular necrosis following treatment with zoledronate (Zometa). Kidney Int 2003;64:281-9.
25. Chang JT, Green L, Beitz J. Renal failure with the use of zoledronic acid. N Engl J Med 2003;349:1676-9.
26. Pecherstorfer M, Ludwig H, Schlosser K, Buck S, Huss HJ, Body JJ. Administration of the bisphosphonate ibandronate (BM 21.0955) by intravenous bolus injection. J Bone Miner Res 1996; 11:587-93.
27. Neugebauer G, Kohler W, Akinkunmi L, Pinner J, Kletzl H, Banken L. Influence of peak ibandronic acid concentrations after 6 mg iv administration with shortened infusion time (15 and 30 minutes) on renal safety in man. Proc Am Soc Clin Oncol 2001;20:122a.