Generic Name: Zoledronic Acid
Class: Bone Resorption Inhibitors
VA Class: HS900
Chemical Name: [1-Hydroxy-2-(1H-imidazol-1-yl)ethylidene]bis-phosphonic acid monohydrate
Molecular Formula: C5H10N2O7P2•H2O
CAS Number: 165800-06-6
Special Alerts:
[Posted 09/01/2011] ISSUE: FDA notified healthcare professionals and patients of an update to the drug label for zoledronic acid (Reclast) regarding the risk of kidney failure. Cases of acute renal failure requiring dialysis or having a fatal outcome following Reclast use have been reported to FDA. The revised label states that Reclast is contraindicated in patients with creatinine clearance less than 35 mL/min or in patients with evidence of acute renal impairment. The label also recommends that healthcare professionals screen patients prior to administering Reclast in order to identify at-risk patients.
The Reclast Medication Guide for patients is being updated to contain information about the risk of severe kidney problems. In addition, the manufacturer of Reclast will issue a Dear Healthcare Provider letter to inform healthcare professionals about this risk.
BACKGROUND: Risk factors for developing renal failure include underlying moderate to severe renal impairment, use of kidney-damaging (nephrotoxic) or diuretic medications at the same time as Reclast, or severe dehydration occurring before or after Reclast is given. The risk of developing renal failure in patients with underlying renal impairment also increases with age.
These labeling changes are being made to the Reclast label only, although zoledronic acid, also sold as Zometa, is approved for treatment of cancer-related indications. Renal toxicity is already addressed in the Warnings and Precautions section of the Zometa label. Dose reductions for Zometa are provided for patients with renal impairment.
RECOMMENDATIONS: Reclast is contraindicated in patients with creatinine clearance less than 35 mL/min, or in patients with evidence of acute renal impairment. Healthcare professionals should screen patients prior to administering Reclast in order to identify at-risk patients. Healthcare professionals should also monitor renal function in patients who are receiving Reclast. For more information visit the FDA website at: and .
[Posted 10/13/2010] ISSUE: FDA is updating the public regarding information previously communicated describing the risk of atypical fractures of the thigh, known as subtrochanteric and diaphyseal femur fractures, in patients who take bisphosphonates for osteoporosis. This information will be added to the Warnings and Precautions section of the labels approved to treat osteoporosis, including alendronate (Fosamax), alendronate with cholecalciferol (Fosamax Plus D), risedronate (Actonel and Atelvia), risedronate with calcium carbonate (Actonel with Calcium), ibandronate (Boniva), tiludronate (Skelid), and zoledronic acid (Reclast) and their generic products. A Medication Guide will also be required to be given to patients when they pick up their bisphosphonate prescription.
BACKGROUND: Atypical subtrochanteric femur fractures are fractures in the bone just below the hip joint. Diaphyseal femur fractures occur in the long part of the thigh bone. These fractures are very uncommon and appear to account for less than 1% of all hip and femur fractures overall. Although it is not clear if bisphosphonates are the cause, these unusual femur fractures have been predominantly reported in patients taking bisphosphonates.
RECOMMENDATIONS: Patients should continue to take their medication unless told to stop by their healthcare professional. FDA recommends that healthcare professionals should discontinue potent antiresorptive medications (including bisphosphonates) in patients who have evidence of a femoral shaft fracture. For more information visit the FDA website at: and .
[Posted 03/11/2010] FDA notified healthcare professionals and patients that at this point, the data that FDA has reviewed have not shown a clear connection between bisphosphonate use and a risk of atypical subtrochanteric femur fractures. FDA is working with outside experts, including members of the recently convened American Society of Bone and Mineral Research Subtrochanteric Femoral Fracture Task Force, to gather more information and evaluate the issue further.
FDA recommends that healthcare professionals follow the recommendations in the drug label when prescribing oral bisphosphonates.
Patients should continue taking oral bisphosphonates unless told by their healthcare professional to stop. Patients should talk to their healthcare professional if they develop new hip or thigh pain or have any concerns with their medications. For more information visit the FDA website at: and .
[Posted 11/12/2008] FDA issued an update to the Agency’s review of safety data regarding the potential increased risk of atrial fibrillation in patients treated with a bisphosphonate drug. Bisphosphonates are a class of drugs used primarily to increase bone mass and reduce the risk for fracture in patients with osteoporosis, slow bone turnover in patients with Paget’s disease of the bone, and to treat bone metastases and lower elevated levels of blood calcium in patients with cancer. FDA reviewed data on 19,687 bisphosphonate-treated patients and 18,358 placebo-treated patients who were followed for 6 months to 3 years. The occurrence of atrial fibrillation was rare within each study, with most studies containing 2 or fewer events. Across all studies, no clear association between overall bisphosphonate exposure and the rate of serious or non-serious atrial fibrillation was observed. Additionally, increasing dose or duration of bisphosphonate therapy was not associated with an increase rate of atrial fibrillation. Healthcare professionals should not alter their prescribing patterns for bisphosphonates and patients should not stop taking their bisphosphonate medication. For more information visit the FDA website at: , and .
[Posted 01/07/2008] FDA informed healthcare professionals and patients of the possibility of severe and sometimes incapacitating bone, joint, and/or muscle (musculoskeletal) pain in patients taking bisphosphonates. Although severe musculoskeletal pain is included in the prescribing information for all bisphosphonates, the association between bisphosphonates and severe musculoskeletal pain may be overlooked by healthcare professionals, delaying diagnosis, prolonging pain and/or impairment, and necessitating the use of analgesics. The severe musculoskeletal pain may occur within days, months, or years after starting a bisphosphonates. Some patients have reported complete relief of symptoms after discontinuing the bisphosphonate, whereas others have reported slow or incomplete resolution. The risk factors for and incidence of severe musculoskeletal pain associated with bisphosphonates are unknown.
Healthcare professionals should consider whether bisphosphonate use might be responsible for severe musculoskeletal pain in patients who present with these symptoms and consider temporary or permanent discontinuation of the drug. For more information visit the FDA website at: and .
[Posted 10/01/2007] FDA issued an early communication about the ongoing review of new safety data regarding the association of atrial fibrillation with the use of bisphosphonates. Bisphosphonates are a class of drugs used primarily to increase bone mass and reduce the risk for fracture in patients with osteoporosis, slow bone turnover in patients with Paget’s disease of the bone, treat bone metastases, and lower elevated levels of blood calcium in patients with cancer.
FDA reviewed spontaneous postmarketing reports of atrial fibrillation reported in association with oral and intravenous bisphosphonates and did not identify a population of bisphosphonate users at increased risk of atrial fibrillation. In addition, as part of the data review for the recent approval of once-yearly Reclast for the treatment of postmenopausal osteoporosis, FDA evaluated the possible association between atrial fibrillation and the use of Reclast (zoledronic acid). Most cases of atrial fibrillation occurred more than a month after drug infusion. Also, in a subset of patients monitored by electrocardiogram up to the 11th day following infusion, there was no significant difference in the prevalence of atrial fibrillation between patients who received Reclast and patients who received placebo.
Upon initial review, it is unclear how these data on serious atrial fibrillation should be interpreted. Therefore, FDA does not believe that healthcare providers or patients should change either their prescribing practices or their use of bisphosphonates at this time. For more information visit the FDA website at: and .
REMS:
FDA approved a REMS for zoledronic acid to ensure that the benefits of a drug outweigh the risks. However, FDA later rescinded REMS requirements. See the FDA REMS page () or the ASHP REMS Resource Center ().
Introduction
Synthetic bisphosphonate; bone resorption inhibitor.1 4 5
Uses for Zometa
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.
Hypercalcemia Associated with Malignancy
Used in conjunction with achievement and maintenance of adequate hydration for the treatment of moderate to severe hypercalcemia (albumin-corrected serum calcium concentration ≥12 mg/dL) associated with malignant neoplasms.1 2 3 5
Retreatment may be considered in patients with recurrent or refractory disease.1 2 3
Bone Metastases of Solid Tumors and Osteolytic Lesions of Multiple Myeloma
Used as an adjunct to antineoplastic therapy for the treatment of osteolytic bone metastases of solid tumors and osteolytic lesions of multiple myeloma.1 7
Second-line therapy of bone metastases associated with prostate cancer in patients with disease progression following one or more hormonal therapies.1 3
Prevention of Aromatase Inhibitor-associated Bone Loss in Postmenopausal Women
May be considered a reasonable choice (accepted, with possible conditions) in postmenopausal women with early-stage breast cancer receiving aromatase inhibitor therapy† who have no additional risk factors and in whom BMD is at least 2.5 standard deviations below normal (T-scores at or below -2.5) either at baseline or during aromatase inhibitor therapy.27 10005
May be considered a reasonable choice (accepted, with possible conditions) on an individualized basis in postmenopausal women with early-stage breast cancer receiving aromatase inhibitor therapy† who have moderate osteopenia (T-scores at or below -2) and have a history of a prior fracture or another clinically important risk factor (e.g., age, maternal history of fracture, low weight or body mass index) or lifestyle-related factor as defined by WHO; such women are at moderate to high risk for fracture development.27
Prevention of Aromatase Inhibitor-associated Bone Loss in Premenopausal Women
Use not fully established because of unclear risk/benefit.27 Improvements in BMD observed in premenopausal women with early-stage breast cancer receiving zoledronic acid concurrently with an aromatase inhibitor-gonadotropin-releasing hormone agonist regimen†.10004 However, long-term follow-up needed, especially as women enter menopause, to establish whether zoledronic acid is associated with clinically important fracture reduction.10004
Zometa Dosage and Administration
General
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.
Monitor hematocrit and hemoglobin regularly.1
Evaluate Scr prior to administration of each dose.1 3 (See Renal Effects under Cautions.)
Carefully monitor standard hypercalcemia-related metabolic parameters (e.g., serum concentrations of calcium, phosphate, magnesium, other electrolytes) following initiation of therapy.1
Hypercalcemia Associated with Malignancy
Adequately hydrate patients prior to treatment initiation and throughout treatment.1 3 Avoid overhydration, especially in patients at risk for the development of heart failure.1 3 Attempt to restore urine output to 2 L/day throughout treatment.1
Bone Metastases of Solid Tumors and Osteolytic Lesions of Multiple Myeloma
Supplemental calcium (500 mg of elemental calcium daily) and a multivitamin containing vitamin D (400 units daily) is recommended in patients with multiple myeloma or bone metastases associated with solid tumors.1 7 (See Metabolic Effects under Cautions.)
Administration
IV Administration
For solution compatibility information, see Compatibility under Stability.
Administer by IV infusion.1 3 7
Must be diluted prior to administration.1
Dilution
Withdraw the appropriate volume of zoledronic acid concentrate needed to provide the prescribed dose (see Table 1) from the 5-mL vial and dilute in 100 mL of 0.9% sodium chloride or 5% dextrose injection.1 Increased risk of renal impairment or failure associated with smaller infusion volumes (e.g., 50 mL).3 4 7
To avoid inadvertent injection of the concentrated solution, do not store the undiluted concentrate in a syringe.1
Zoledronic Acid Dose | Volume of Concentrate to be Diluted |
|---|---|
4 mg | 5 mL |
3.5 mg | 4.4. mL |
3.3 mg | 4.1 mL |
3 mg | 3.8 mL |
Rate of Administration
Administer by IV infusion over ≥15 minutes.1 3 7 Rapid IV infusion rates (5 minutes) are associated with an increased risk of renal impairment and renal failure.1 3 4 7
Dosage
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.
Available as zoledronic acid (as the monohydrate); dosage expressed in terms of the anhydrous drug.1 1
Adults
Hypercalcemia Associated with Malignancy
IV
4 mg as a single dose in patients with an albumin-corrected serum calcium concentration of ≥12 mg/dL.1 3
Consider retreatment if serum calcium concentrations do not return to normal or do not remain normal.1 Initial dose can be repeated ≥7 days after treatment initiation to allow full response to initial dose.1
Bone Metastases of Solid Tumors and Osteolytic Lesions of Multiple Myeloma
IV
4 mg once every 3–4 weeks in patients with baseline Clcr >60 mL/minute.1 3 Optimum duration of such therapy is not known, but has been used at the recommended interval for 4–12 months.1 3 7
If renal function deteriorates (defined as an increase in Scr of ≥0.5 mg/dL) in patients with a baseline Scr of <1.4 mg/dL, withhold therapy until Scr returns to within 10% of baseline levels.1 3 7 Reinitiate therapy at the same dosage used prior to treatment interruption.1 3 7
Prevention of Aromatase Inhibitor-associated Bone Loss† in Postmenopausal Women
IV
Dosage of 4 mg once every 6 months has been used in clinical trials in women with early-stage breast cancer.10001
Prescribing Limits
Adults
Hypercalcemia Associated with Malignancy
IV
Maximum 4 mg as a single dose.1 3 5 7 Safety and efficacy of >1 course of retreatment not established.2 3
Bone Metastases of Solid Tumors and Osteolytic Lesions of Multiple Myeloma
IV
Maximum 4 mg as a single dose.1 3 5 7
Special Populations
Hepatic Impairment
No dosage recommendations at this time.1
Renal Impairment
Hypercalcemia Associated with Malignancy
IV
Dosage adjustments are not necessary in patients with mild to moderate renal impairment (Scr <4.5 mg/dL).1
Bone Metastases of Solid Tumors and Osteolytic Lesions of Multiple Myeloma
IV
In patients with mild to moderate renal impairment (baseline Clcr of 30–60 mL/minute), lower initial dosages of zoledronic acid are recommended.1 (See Table 2.)
Calculated Clcr (mL/minute) | IV Dosage |
|---|---|
>60 | 4 mg every 3–4 weeks |
50–60 | 3.5 mg every 3–4 weeks |
40–49 | 3.3 mg every 3–4 weeks |
30–39 | 3 mg every 3–4 weeks |
If renal function deteriorates (defined as an increase in Scr of ≥1 mg/dL) in patients with a baseline Scr of ≥1.4 mg/dL, withhold therapy until Scr returns to within 10% of baseline levels.1 3 7 Reinitiate therapy at the same dosage that was used prior to the treatment interruption.1 Studies in this patient population included individuals with Scr <3 mg/dL.1 3 7
Geriatric Patients
No dosage recommendations at this time.1
Cautions for Zometa
Contraindications
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.
Known hypersensitivity to zoledronic acid, other bisphosphonates, or any ingredient in the formulation.1 2
Warnings/Precautions
Warnings
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.
Fetal/Neonatal Morbidity
May cause fetal harm; use not recommended in pregnant women, and women of childbearing potential should avoid conception during therapy.1 (See Advice to Patients.)
Renal Effects
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.
Renal toxicity (e.g., deterioration of renal function and potential renal failure)1 2 3 4 7 has occurred following administration of higher than recommended doses.1 Renal impairment also has occurred after administration of the usual dose (4 mg) infused over the recommended infusion period (15 minutes)1 11 and after administration of the usual initial dose.1
Risk of adverse renal effects depends on coexisting conditions, concomitant nephrotoxic therapy, preexisting renal disease, dosage, infusion volume and rate, dehydration, and multiple cycles of treatment.1 2 3 4 5 7 Such risk factors should be identified and managed.1 Weigh the risks versus the potential benefits of subsequent treatment in patients with hypercalcemia of malignancy and severe renal impairment if renal function deteriorates during therapy.1
Monitor Scr and assess possible deterioration in renal function prior to each dose.1 3
General Precautions
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.
Metabolic Effects
Possible hypocalcemia, hypophosphatemia, or hypomagnesemia.1
Carefully monitor standard hypercalcemia-related metabolic parameters (e.g., serum concentrations of calcium, phosphate, magnesium, and potassium) following initiation of therapy.1 3 Institute short-term supplemental therapy if hypocalcemia, hypophosphatemia, or hypomagnesemia occurs.1 3
Musculoskeletal Effects
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.
Osteonecrosis and osteomyelitis of the jaw have been reported in cancer patients receiving bisphosphonates.1 12 13 14 Most patients were receiving concurrent chemotherapy and corticosteroids1 13 14 and the majority of cases were associated with dental procedures (e.g., tooth extraction).1 12 13 14
A dental examination with appropriate preventive dentistry recommended prior to treatment with bisphosphonates in patients with concomitant risk factors (e.g. cancer, chemotherapy, corticosteroids, poor oral hygiene).1 12 13 Avoid invasive dental procedures if possible during therapy in such patients.1 13
Severe, occasionally incapacitating bone, joint, and/or muscle pain have been reported infrequently.1 The time to the onset of symptoms varied from 1 day to several months after treatment initiation.1 Such pain improves following discontinuance of the drug and may recur upon subsequent rechallenge.1
Hematologic Effects
Possible anemia; monitor hematocrit and hemoglobin regularly throughout treatment.1
Respiratory Effects
Possible bronchoconstriction in aspirin-sensitive asthmatic patients.1 Use with caution in such patients.1
Specific Populations
Pregnancy
Category D.1 (See Fetal/Neonatal Morbidity under Cautions.)
Lactation
Not known if zoledronic acid is distributed into milk; discontinue nursing or the drug.1
Pediatric Use
Safety and efficacy not established.1 Because of long-term retention in bone, use recommended only if the potential benefit from the drug outweighs the possible risk.1
Geriatric Use
No substantial differences in safety and efficacy relative to younger adults.1
Possible age-related impaired renal function.1 Careful renal function monitoring recommended.1
Renal Impairment
Possible renal toxicity.1
Use in patients with hypercalcemia of malignancy and severe renal impairment only after consideration of other treatment options.1 3 Carefully weigh the possible benefits and risks of therapy.1 3 Use not recommended in patients with bone metastases and severe renal impairment.1 3 (See Renal Effects under Cautions.)
Common Adverse Effects
Patients with hypercalcemia of malignancy: Fever,1 2 3 5 nausea,1 2 3 5 constipation,1 2 3 5 anemia,1 2 3 5 dyspnea,1 2 3 5 diarrhea,1 2 3 progression of cancer,1 3 abdominal pain,1 2 3 insomnia,1 2 3 vomiting,1 2 3 urinary tract infection,1 3 anxiety,1 hypophosphatemia,1 confusion,1 2 3 5 agitation,1 moniliasis,1 hypokalemia,1 2 3 5 skeletal pain,1 3 cough,1 hypotension,1 hypomagnesemia.1
Patients with bone metastases of solid tumors and osteolytic lesions of multiple myeloma: Nausea,1 3 5 7 fatigue,1 3 7 anemia,1 3 5 7 vomiting,1 3 7 fever,1 3 5 7 constipation,1 3 5 7 dyspnea,1 3 5 7 diarrhea,1 3 7 myalgia,1 cough,1 7 edema of the lower extremities,1 7 arthralgia,1 3 7 headache,1 3 7 dizziness,1 3 weight loss,1 3 7 paresthesia,1 3 depression,1 3 abdominal pain,1 3 dehydration,1 3 limb pain,1 decreased appetite,1 neutropenia,1 3 urinary tract infection,1 3 hypoesthesia,1 3 anxiety,1 alopecia,1 7 dermatitis,1 3 rigors,1 3 thrombocytopenia,3 dyspepsia,1 upper respiratory tract infection.1
Interactions for Zometa
Does not inhibit CYP isoenzymes.1
Nephrotoxic Agents
Potential pharmacologic interaction (increased risk of renal toxicity).1 Use concomitantly with caution.1 (See Renal Effects under Cautions.)
Specific Drugs
Drug | Interaction | Comments |
|---|---|---|
Aminoglycosides | Potential for additive effect in lowering serum calcium concentrations1 | Such effect not reported1 |
Loop diuretics | Increased risk of hypocalcemia1 | Use caution1 |
Thalidomide | Potential for increased risk of renal dysfunction in patients with multiple myeloma1 |
Zometa Pharmacokinetics
Absorption
Onset
Hypercalcemia of malignancy: Normocalcemia usually is apparent within 7–10 days.1 2 3
Duration
Hypercalcemia of malignancy: Median time to recurrence (time to last corrected serum calcium concentration of <11.6 mg/dL) was 30 days.1
Prostate cancer: Bone-related complications not observed within 10.5 months of therapy.1
Bone metastases of breast cancer and osteolytic lesions of multiple myeloma: Median time to first bone-related complication was 373 days.1
Bone metastases of solid tumors other than breast or prostate cancer: Median time to the first bone-related complication was 230 days.1
Special Populations
In adults with mild or moderate renal impairment, the AUC is increased 15 or 43%, respectively, compared with patients with normal renal function.1
Distribution
Extent
Distributes rapidly to skeletal tissues.1 Subsequently, the drug is released systemically via bone turnover.1 Not known whether distributed into breast milk.1
Plasma Protein Binding
Approximately 22%.1
Elimination
Metabolism
No evidence of metabolism.1
Elimination Route
In patients with cancer and bone metastases, excreted in urine (39% within 24 hours) as unchanged drug.1
Half-life
Terminal half-life is 146 hours.1
Special Populations
Pharmacokinetics not evaluated in patients with hepatic impairment and in pediatric patients.1
Pharmacokinetics not affected by age or race in patients with cancer and bone metastases.1
Stability
Storage
Parenteral
Solution for Injection
25°C (may be exposed to 15–30°C).1 Following dilution, 2–8°C; use within 24 hours.1
Compatibility
For information on systemic interactions resulting from concomitant use, see Interactions.
Do not admix with other agents.1
Solution Compatibility1
Compatible |
|---|
Dextrose 5% in water |
Sodium chloride 0.9% |
Incompatible |
Ringer’s injection, lactated |
Actions
Incorporates into bone and selectively inhibits osteoclast-mediated bone resorption.1 4 5
Inhibits increased osteoclastic activity and skeletal calcium release induced by tumors.1
Decreases serum calcium and phosphorus and increases urinary calcium and phosphorus excretion in patients with hypercalcemia of malignancy.1
Advice to Patients
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.
Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1 3 Advise women of childbearing potential to avoid pregnancy.1 If pregnant, apprise of potential fetal hazard.1
Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.1
Importance of advising patients of other important precautionary information.1 (See Cautions.)
Preparations
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Parenteral | For injection, concentrate, for IV infusion | 4 mg (of anhydrous zoledronic acid) per 5 mL | Zometa | Novartis |
Comparative Pricing
This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 10/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.
Reclast 5MG/100ML Solution (NOVARTIS): 100/$1,137.19 or 300/$3,282.53
Disclaimer
This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.
The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.
AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions October 27, 2011. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.
† Use is not currently included in the labeling approved by the US Food and Drug Administration.
References
1. Novartis. Zometa (zoledronic acid) injection prescribing information. East Hanover, NJ; 2005 Apr.
2. Major P, Lortholary A, Han J et al. Zoledronic acid is superior to pamidronate in the treatment of hypercalcemia of malignancy: a pooled analysis of two randomized, controlled clinical trials. J Clin Oncol. 2001; 19:558-67. [IDIS 460631] [PubMed 11208851]
3. Novartis Pharmaceuticals, East Hanover, NJ; Personal communication.
4. Brown DL, Robbins R. Developments in the therapeutic applications of bisphosphonates. J Clin Pharmacol. 1999; 39:651-60. [IDIS 430233] [PubMed 10392318]
5. Cheer SM, Noble S. Zoledronic acid. Drugs. 2001; 61:799-805. [PubMed 11398911]
6. Anon. Zoledronate (Zometa). Med Lett Drugs Ther. 2001; 43:110-11. [PubMed 11740412]
7. Rosen LS, Gordon D, Kaminski M 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. [PubMed 11693896]
8. Green JR. Chemical and biological prerequisites for novel bisphosphonate molecules: Results of comparative preclinical studies. Semin Oncol. 2001; 28(Suppl. 6):4-10 [PubMed 11346859]
9. Plosker GL, Goa KL. Clodronate. A review of its pharmacological properties and therapeutic efficacy in resorptive bone disease. Drugs. 1994; 47:945-82. [PubMed 7521833]
10. Coukell AJ, Markham A. Pamidronate. A review of its use in the management of osteolytic bone metastases, tumour-induced hypercalcaemia and Paget’s disease of bone. Drugs Aging. 1998; 12:149-68. [PubMed 9509293]
11. Bone HG, Santora AC. Ten years of alendronate treatment for osteoporosis in postmenopausal women. N Engl J Med. 2004; 351:191-2.
12. Ruggiero SL, Mehrotra B, Rosenberg TJ et al. Osteonecrosis of the jaw associated with the use of bisphosphonates: a review of 63 cases. J Oral Maxillofac Surg. 2004; 62:527-34. [IDIS 518769] [PubMed 15122554]
13. Hohneker JA. Dear doctor letter regarding osteonecrosis of the jaw in patients with cancer receiving bisphophonates. East Hanover, NJ: Novartis; 2004 September 24.
14. Ruggiero SL, Mehrotra B. Ten years of alendronate treatment for osteoporosis in postmenopausal women. N Engl J Med. 2004; 351:191.
26. Eidtmann H, Bundred NJ, DeBoer R et al. The effect of zoledronic acid on aromatase inhibitor associated bone loss in postmenopausal women with early breast cancer receiving adjuvant letrozole: 36 months follow up of ZO-FAST. Oral presentation at Annual San Antonio Breast Cancer Symposium. San Antonio, TX: 2008 Dec 12. Accessed from website on 12/15/2008.
27. Zoledronic Acid Final Determination. Published May 2008. From AHFS website.
28. Gnant M, Mlineritsch B, Luschin-Ebengreuth G et al. Adjuvant endocrine therapy plus zoledronic acid in premenopausal women with early-stage breast cancer: 5-year follow-up of the ABCSG-12 bone-mineral density study. Lancet Oncol. 2008; 9:840-49. [PubMed 18718815]
10001. Brufsky A, Harker WG, Beck JT et al. Zoledronic acid inhibits adjuvant letrozole-induced bone loss in postmenopausal women with early breast cancer. J Clin Oncol. 2007; 25: 829-36. [PubMed 17159193]
10002. Brufsky A, Lund K, Cobb P et al. Twenty-four month follow-up of the effect of zoledronic acid on aromatase inhibitor-associated bone loss in postmenopausal women with early breast cancer receiving adjuvant letrozole. Poster presented at Annual San Antonio Breast Cancer Symposium. San Antonio, TX: 2006 Dec 16. Abstract 5060. Accessed from website on 4/29/2008.
10003. Mincey BA, Dentchev TG, Sloan JA et al. NO3CC- A randomized, controlled, open-label trial of upfront versus delayed zoledronic acid for prevention of bone loss in postmenopausal women with primary breast cancer starting letrozole after tamoxifen. J Clin Oncol. 2008; 26: Abstract No. 564.
10004. Gnant MF, Mlineritsch B, Luschin-Ebengreith G et al. Zoledronic acid prevents cancer treatment-induced bone loss in premenopausal women receiving adjuvant endocrine therapy for hormone-responsive breast cancer: a report from the Austrian Breast and Colorectal Cancer Study Group. J Clin Oncol. 2007; 25: 820-8. [PubMed 17159195]
10005. Hillner BE, Ingle JN, Chelebowski RT et al. American Society of Clinical Oncology 2003 update on the role of bisphosphonates and bone health issues in women with breast cancer. J Clin Oncol. 2003; 21:4042-57. [IDIS 513063] [PubMed 12963702]
10006. Eastell R. Breast cancer and the risk of osteoporotic fracture: a paradox. J Clin Endocrinol Metab. 2007; 92: 42-3. [PubMed 17209223]
10007. Cummings SR, Bates D, Black DM. Clinical use of bone densitometry: scientific review. JAMA. 2002; 288: 1889-97. [PubMed 12377088]
10008. Wasnich RD, Miller PD. Antifracture efficacy of antiresorptive agents are related to changes in bone density. J Clin Endocrinol Metab. 2000; 85; 231-6. [PubMed 10634392]
10009. Hochberg MC, Greenspan S, Wasnich RD, et al. 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. 2002; 87: 1586-92. [PubMed 11932287]
10010. Phase III randomized study of immediate versus delayed zoledronate for prevention of bone loss in postmenopausal women with stage I-IIIA breast cancer initiating letrozole after prior treatment with tamoxifen. Accessed from website on June 4, 2008.
10011. US Food and Drug Administration (FDA). Guidance for preclinical and clinical evaluation of agents used in the prevention of postmenopausal osteoporosis. Rockville, MD: FDA; 1994 Apr.
10012. Gnant MF, Jakesz R, Mlineritsch B et al. Zoledronic acid effectively counteracts cancer treatment induced bone
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