zoledronate (Zometa, Reclast)

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Indications

* yearly IV zoledronate generally approved by Medicare only if contraindications to oral bisphosphates (dysphagia, esophageal stricture, GERD requiring daily PPI)[20]

Contraindications

* see notes

Benefit/risk

Dosage

* dental examination prior to administration

* correct vitamin D deficiency prior to administration for osteoporosis

* risk for subsequent osteoporotic fracture during the following 3 years is low if Z score > -2.5, no recent fracture & no more than 1 risk factor[17]

Dosage adjustment in renal failure

eGFR Dosage
> 60 mL/min 4.0 mg
55-60 mL/min 3.5 mg
40-49 mL/min 3.3 mg
35-39 mL/min 3.0 mg

Pharmacokinetics

  • eliminated in the urine

Adverse effects

*dental consultation

Mechanism of action

Notes

More general terms

Additional terms

References

  1. Prescriber's Letter 8(9):53 2001
  2. Journal Watch 22(7):53, 2002 Reid et al, N Engl J Med 346:653, 2002
  3. 3.0 3.1 FDA Safteywatch http://www.fda.gov/medwatch/SAFETY/2005/safety05.htm#Zometa
  4. FDA Safteywatch http://www.fda.gov/medwatch/SAFETY/2005/safety05.htm#zometa2
  5. 5.0 5.1 5.2 Reid IR et al, Comparison of a single infusion of zoledronic acid with risedronate for Paget's disease. N Engl J Med 2005 Sep 1; 353:898-908 PMID: https://www.ncbi.nlm.nih.gov/pubmed/16135834
  6. Prescriber's Letter 14(6): 2007 New Developments With Bisphosphonate Therapy Detail-Document#: http://prescribersletter.com/(5bhgn1a4ni4cyp2tvybwfh55)/pl/ArticleDD.aspx?li=1&st=1&cs=&s=PRL&pt=3&fpt=25&dd=230613&pb=PRL (subscription needed) http://www.prescribersletter.com
  7. Prescriber's Letter 14(9): 2007 Once-yearly Osteoporosis Treatment and Other Bisphosphonate Developments PATIENT HANDOUT: Bisphosphonates and Jaw Bone Damage INFORMATION FOR DENTISTS: American Dental Association recommendations for patients taking oral bisphosphonates RECLAST FOR OSTEOPOROSIS Detail-Document#: http://prescribersletter.com/(5bhgn1a4ni4cyp2tvybwfh55)/pl/ArticleDD.aspx?li=1&st=1&cs=&s=PRL&pt=3&fpt=25&dd=230902&pb=PRL (subscription needed) http://www.prescribersletter.com
  8. 8.0 8.1 Black DM, Delmas PD, Eastell R, Reid IR, Boonen S, Cauley JA, Cosman F, Lakatos P, Leung PC, Man Z, Mautalen C, Mesenbrink P, Hu H, Caminis J, Tong K, Rosario-Jansen T, Krasnow J, Hue TF, Sellmeyer D, Eriksen EF, Cummings SR; HORIZON Pivotal Fracture Trial. Once-yearly zoledronic acid for treatment of postmenopausal osteoporosis. N Engl J Med. 2007 May 3;356(18):1809-22. PMID: https://www.ncbi.nlm.nih.gov/pubmed/17476007
  9. 9.0 9.1 Lyles KW et al, Zoledronic acid and clinical fractures and mortality after hip fracture. N Engl J Med 2007 357:[ePub] http://dx.doi.org/10.1056/NEJMoa74941 PMID: https://www.ncbi.nlm.nih.gov/pubmed/17878149
  10. Prescriber's Letter 14(11): 2007 Zoledronic Acid (Reclast) After an Initial Hip Fracture Detail-Document#: http://prescribersletter.com/(5bhgn1a4ni4cyp2tvybwfh55)/pl/ArticleDD.aspx?li=1&st=1&cs=&s=PRL&pt=3&fpt=25&dd=231114&pb=PRL (subscription needed) http://www.prescribersletter.com
  11. 11.0 11.1 Reid DM et al, Zoledronic acid and risedronate in the prevention and treatment of glucocorticoid-induced osteoporosis (HORIZON): a multicentre, double-blind, double-dummy, randomised controlled trial Lancet 2009 373:1253-1263, 11 April 2009 PMID: https://www.ncbi.nlm.nih.gov/pubmed/19362675
  12. 12.0 12.1 FDA Drug Safety Newsletter - Volume 2, Number 2, 2009 http://www.fda.gov/Drugs/DrugSafety/DrugSafetyNewsletter/ucm167843.htm
  13. 13.0 13.1 McClung M et al. Zoledronic acid for the prevention of bone loss in postmenopausal women with low bone mass: A randomized controlled trial. Obstet Gynecol 2009 Nov; 114:999. PMID: https://www.ncbi.nlm.nih.gov/pubmed/20168099
  14. 14.0 14.1 FDA MedWatch 09/01/11 Reclast (zoledronic acid): Drug Safety Communication - New Contraindication and Updated Warning on Kidney Impairment http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm270464.htm
  15. 15.0 15.1 15.2 Whitaker M et al Bisphosphonates for Osteoporosis - Where Do We Go from Here? N Engl J Med 2012 May 9, <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/22571168 <Internet> http://www.nejm.org/doi/full/10.1056/NEJMp1202619
    Black DM et al Continuing Bisphosphonate Treatment for Osteoporosis - For Whom and for How Long? N Engl J Med 2012 May 9, <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/22571169 <Internet> http://www.nejm.org/doi/full/10.1056/NEJMp1202623
  16. 16.0 16.1 Deprecated Reference
  17. 17.0 17.1 Cosman F et al. Reassessment of fracture risk in women after 3 years of treatment with zoledronic acid: When is it reasonable to discontinue treatment? J Clin Endocrinol Metab 2014 Dec; 99:4546 PMID: https://www.ncbi.nlm.nih.gov/pubmed/25215556
  18. 18.0 18.1 Greenspan SL et al Efficacy and Safety of Single-Dose Zoledronic Acid for Osteoporosis in Frail Elderly WomenA Randomized Clinical Trial. JAMA Intern Med. Published online April 13, 2015 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/25867538 <Internet> http://archinte.jamanetwork.com/article.aspx?articleid=2247163
    Lindsay R Osteoporosis Treatment and Fracture Outcomes. JAMA Intern Med. Published online April 13, 2015 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/25866943 <Internet> http://archinte.jamanetwork.com/article.aspx?articleid=2247159
  19. 19.0 19.1 Reid IR Efficacy, effectiveness and side effects of medications used to prevent fractures. J Intern Med. 2015 Jun;277(6):690-706 PMID: https://www.ncbi.nlm.nih.gov/pubmed/25495429
  20. 20.0 20.1 20.2 20.3 Geriatric Review Syllabus, 9th edition (GRS9) Medinal-Walpole A, Pacala JT, Porter JF (eds) American Geriatrics Society, 2016
  21. Maricic M. Intravenous zoledronic acid: what are the indications for male osteoporosis? Curr Osteoporos Rep. 2010 Mar;8(1):4-9. PMID: https://www.ncbi.nlm.nih.gov/pubmed/20425084
  22. Maricic M. The role of zoledronic acid in the management of osteoporosis. Clin Rheumatol. 2010 Oct;29(10):1079-84. Review. PMID: https://www.ncbi.nlm.nih.gov/pubmed/20544246
  23. 23.0 23.1 23.2 Reid IR, Horne AM, Mihov B et al Fracture Prevention with Zoledronate in Older Women with Osteopenia. N Engl J Med 2018;379:2407-2416. Oct 1, 2018 Not indexed in PubMed. Published Online. https://www.nejm.org/doi/full/10.1056/NEJMoa1808082
    Rosen CJ A Not-So-New Treatment for Old Bones. N Engl J Med. Oct 1, 2018 PMID: https://www.ncbi.nlm.nih.gov/pubmed/30273092 DOI: Free full text https://www.nejm.org/doi/full/10.1056/NEJMe1812434
  24. Kaur U, Chakrabarti SS, Gambhir IS. Zoledronate Induced Hypocalcemia and Hypophosphatemia in Osteoporosis: A Cause of Concern. Curr Drug Saf. 2016;11(3):267-9. PMID: https://www.ncbi.nlm.nih.gov/pubmed/27113952
  25. 25.0 25.1 Geriatric Review Syllabus, 10th edition (GRS10) Harper GM, Lyons WL, Potter JF (eds) American Geriatrics Society, 2019
  26. 26.0 26.1 Medical Knowledge Self Assessment Program (MKSAP) 19 American College of Physicians, Philadelphia 2022
  27. An JN, Kim JK, Lee HS, Kim SG, Kim HJ, Song YR. Serum cystatin C to creatinine ratio is associated with sarcopenia in non-dialysis-dependent chronic kidney disease. Kidney Res Clin Pract. 2022 Sep;41(5):580-590. PMID: https://www.ncbi.nlm.nih.gov/pubmed/35791742 PMCID: PMC9576455 Free PMC article.

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