Effects of intravenous ibandronate injection on renal function in women with postmenopausal osteoporosis at high risk for renal disease - The DIVINE study

Bone

Volumn 49, Issue 6, 2011, Pages 1317-1322

  D Miller, Paul ^a   Ragi Eis, Sergio ^b   Mautalen, Carlos ^c   Ramirez, Francisco ^d   Jonkanski, Iris ^e  

^a Health Sciences Center and Colorado Center for Bone Research   (United States)

^b CEDOES Centro de Diagnostico e Pesquisa   (Brazil)

^c Centro de Osteopatias Medicas   (Argentina)

^d ROCHE PRODUCTS LTD   (United Kingdom)

^e F HOFFMANN LA ROCHE LTD   (Switzerland)

Author keywords

DIVINE; Ibandronate; Intravenous bisphosphonates; Postmenopausal osteoporosis; Renal disease; Renal function

Indexed keywords

ALENDRONIC ACID; CALCIUM; IBANDRONIC ACID; VITAMIN D;

ABDOMINAL PAIN; ADULT; AGED; ARTHRALGIA; ARTICLE; BACKACHE; CONTROLLED STUDY; COUGHING; CREATININE BLOOD LEVEL; DIARRHEA; DIZZINESS; DRUG EFFICACY; DRUG INDUCED HEADACHE; DRUG SAFETY; DYSPEPSIA; FEMALE; GASTRITIS; GLOMERULUS FILTRATION RATE; HIGH RISK POPULATION; HUMAN; HYPERTENSION; INFLUENZA; KIDNEY FUNCTION; MAJOR CLINICAL STUDY; MULTICENTER STUDY; MUSCULOSKELETAL PAIN; MYALGIA; POSTMENOPAUSE OSTEOPOROSIS; RANDOMIZED CONTROLLED TRIAL; TREATMENT DURATION; TREATMENT OUTCOME;

AGED; BONE DENSITY CONSERVATION AGENTS; DIPHOSPHONATES; ENDPOINT DETERMINATION; FEMALE; GLOMERULAR FILTRATION RATE; HUMANS; INJECTIONS, INTRAVENOUS; KIDNEY DISEASES; KIDNEY FUNCTION TESTS; OSTEOPOROSIS, POSTMENOPAUSAL; RISK FACTORS;

EID: 81355127352     PISSN: 87563282     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.bone.2011.09.035     Document Type: Article

References (21)

1. Recker R.R., Lewiecki E.M., Miller P.D., Reiffel J. Safety of bisphosphonates in the treatment of osteoporosis. Am J Med 2009, 122:S22-S32.
2. Lewiecki E.M., Miller P.D. Renal safety of intravenous bisphosphonates in the treatment of osteoporosis. Expert Opin Drug Saf 2007, 6:663-672.
3. Bobba R.S., Beattie K., Parkinson B., Kumbhare D., Adachi J.D. Tolerability of different dosing regimens of bisphosphonates for the treatment of osteoporosis and malignant bone disease. Drug Saf 2006, 29:1133-1152.
4. Miller P.D. The kidney and bisphosphonates. Bone 2011, 49(1):77-81.
5. Lin J.H., Russell G., Gertz B. Pharmacokinetics of alendronate: an overview. Int J Clin Pract Suppl 1999, 101:18-26.
6. US Food and Drug Administration. Adverse Event Reporting Systems (AERS): Healthcare Professionals. The Drug Safety Newsletter. In: Vol 2; No 2.; 2009.
7. Bounameaux H.M., Schifferli J., Montani J.P., Jung A., Chatelanat F. Renal failure associated with intravenous diphosphonates. Lancet 1983, 1:471.
8. Recker R., Stakkestad J.A., Chesnut C.H., Christiansen C., Skag A., Hoiseth A., et al. Insufficiently dosed intravenous ibandronate injections are associated with suboptimal antifracture efficacy in postmenopausal osteoporosis. Bone 2004, 34:890-899.
9. Adami S., Felsenberg D., Christiansen C., Robinson J., Lorenc R.S., Mahoney P., et al. Efficacy and safety of ibandronate given by intravenous injection once every 3 months. Bone 2004, 34:881-889.
10. Eisman J.A., Civitelli R., Adami S., Czerwinski E., Recknor C., Prince R., et al. Efficacy and tolerability of intravenous ibandronate injections in postmenopausal osteoporosis: 2-year results from the DIVA study. J Rheumatol 2008, 35:488-497.
11. Miller P.D., Ward P., Pfister T., Leigh C., Body J.J. Renal tolerability of intermittent intravenous ibandronate treatment for patients with postmenopausal osteoporosis: a review. Clin Exp Rheumatol 2008, 26:1125-1133.
12. Eisman J.A., Garcia-Hernandez P.A., Ortiz-Luna G., Ste-Marie L.G., Hughes C., Mairon N., et al. Intermittent intravenous ibandronate injections are an effective treatment option in postmenopausal osteoporosis: 2-year results from Diva [abstract P316SA]. Osteoporos Int 2006, 17:S212.
13. Thiebaud D., Burckhardt P., Kriegbaum H., Huss H., Mulder H., Juttmann J.R., et al. Three monthly intravenous injections of ibandronate in the treatment of postmenopausal osteoporosis. Am J Med 1997, 103:298-307.
14. Stevens L.A., Levey A.S. Frequently asked questions about GFR estimates 2007, National Kidney Foundation, New York, NY.
15. Levey A.S., Coresh J., Balk E., Kausz A.T., Levin A., Steffes M.W., et al. National Kidney Foundation practice guidelines for chronic kidney disease: evaluation, classification, and stratification. Ann Intern Med 2003, 139:137-147.
16. Cockcroft D.W., Gault M.H. Prediction of creatinine clearance from serum creatinine. Nephron 1976, 16:31-41.
17. Levey A.S., Bosch J.P., Lewis J.B., Greene T., Rogers N., Roth D. A more accurate method to estimate glomerular filtration rate from serum creatinine: a new prediction equation. Modification of Diet in Renal Disease Study Group. Ann Intern Med 1999, 130:461-470.
18. Eisman J.A., Rizzoli R., Roman-Ivorra J., Lipschitz S., Verbruggen N., Gaines K.A., et al. Upper gastrointestinal and overall tolerability of alendronate once weekly in patients with osteoporosis: results of a randomized, double-blind, placebo-controlled study. Curr Med Res Opin 2004, 20:699-705.
19. Czerwinski E., Strugala C., Burdeska A., Stakkestad J.A. Continued favourable renal tolerability with ibandronate intravenous injections in women with postmenopausal osteoporosis: The DIVA study LTE. Ann Rheum Dis 2008, 67(Suppl II):404.
20. Miller P.D., Lewiecki E.M., Kohles J.D. A pooled analysis demonstrates IV ibandronate injection is associated with a favorable renal safety profile. J Clin Densitom 2007, 10:S218.
21. Genentech Boniva (ibandronate sodium) US prescribing information 2010, Genentech USA, Inc., South San Francisco.