Boniva

Generic Name: Ibandronate Sodium
Class: Bone Resorption Inhibitors
VA Class: HS900
Chemical Name: [1-Hydroxy-3-(methylpentylamino)propylidene]diphosphonate trihydrogen sodium monohydrate
Molecular Formula: C₉H₂₂NNaO₇
CAS Number: 138926-19-9

Special Alerts:

[Posted 07/21/2011] ISSUE: FDA notified healthcare professionals and patients about its ongoing review of data from published studies to evaluate whether use of oral bisphosphonate drugs is associated with an increased risk of cancer of the esophagus. FDA has not concluded that taking an oral bisphosphonate drug increases the risk of esophageal cancer. There are insufficient data to recommend endoscopic screening of asymptomatic patients. FDA will continue to evaluate all available data supporting the safety and effectiveness of bisphosphonate drugs and will update the public when more information becomes available.

BACKGROUND: Oral bisphosphonates are commonly used for the prevention and treatment of osteoporosis as well as to treat other bone diseases such as Paget’s disease. There have been conflicting findings from studies evaluating the risk of esophageal cancer. Esophagitis and other esophageal events have been reported, particularly in patients who do not follow the specific directions for use of oral bisphosphonates. See the Data Summary in the Drug Safety Communication for additional details at: .

RECOMMENDATION: Patients should talk with their healthcare professional about the benefits and risks of taking oral bisphosphonates and how long they should expect to take them. Patients should talk with their healthcare professional if they develop swallowing difficulties, chest pain, new or worsening heartburn, or have trouble or pain when swallowing. Patients should be instructed to carefully follow the directions for use of the oral bisphosphonate drug they are prescribed. 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 ibandronate sodium 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}

Uses for Boniva

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.

Osteoporosis

Prevention of osteoporosis in postmenopausal women.¹ Risk factors include a family history of osteoporosis, early menopause, previous fracture, high bone turnover, reduced bone mineral density (≥1 standard deviation below premenopausal mean), thin body frame, white or Asian race, excessive alcohol intake, treatment with certain drugs (e.g., corticosteroids), low dietary calcium or vitamin D intake, sedentary lifestyle, and cigarette smoking.^{1 5 6 8 18}

Treatment of osteoporosis in postmenopausal women.^{1 3 7}

Boniva 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.

• 
  

  Oral: Provide supplemental calcium and vitamin D^{1 7} if dietary intake is inadequate.^{1 18}

  
  


• 
  

  IV: Supplemental calcium and vitamin D required regardless of the adequacy of dietary intake of calcium and vitamin D.^{7 18}

  
  

Administration

Oral Administration

Administer orally with a full glass (180–240 mL) of plain water ≥60 minutes prior to the first food, beverage (other than plain water), or other orally administered drug or supplement (including vitamins, antacids, and calcium) of the day.^{1 4 5 16} (See Food under Pharmacokinetics.)

Avoid lying down for ≥60 minutes following administration.^{1 5}

Do not to suck or chew tablets; potential for oropharyngeal ulceration.^{1 5} (See GI Effects under Cautions.)

If a morning daily oral dose is missed, do not take missed dose later that same day.⁵ Resume the regular schedule the next day.^{1 5}

When administered monthly, take tablets in the morning on the same day each month.^{1 a} If a monthly dose is missed and the next scheduled dose is more than 7 days away, take the missed dose the next morning after it is remembered and resume the regular schedule.^{1 a} If the next scheduled dose is 1–7 days away, maintain the regular schedule;¹ do not take more than one 150-mg tablet within the same week.^{1 a}

IV Administration

Administer by IV injection once every 3 months by a health-care professional.⁷

Injection must only be administered IV.^{1 7 18} Safety and efficacy of IV injection administered by other routes not established.⁷

If a dose is missed, reschedule administration with a health-care professional as soon as possible.^{7 8} Schedule subsequent injections at 3-month intervals; should not be administered more often than once every 3 months.^{7 8}

Administration Risks

Take care to avoid intra-arterial or paravenous injection as such administration could result in tissue damage.⁷

Rate of Administration

Administer IV over a period of 15–30 seconds.^{7 8}

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 ibandronate sodium (as the monosodium monohydrate); dosage expressed in terms of ibandronate.^{1 7}

Adults

Osteoporosis

Prevention in Postmenopausal Women

Oral

2.5 mg once daily.¹ Alternatively, a dosage of 150 mg once monthly may be considered.¹

Osteoporosis

Treatment in Postmenopausal Women

Oral

2.5 mg once daily or 150 mg once monthly.¹

IV

3 mg once every 3 months.⁷

Special Populations

Hepatic Impairment

Dosage adjustments not necessary.^{1 7}

Renal Impairment

Oral

Dosage adjustments not necessary in patients with mild to moderate renal impairment (Cl_cr ≥30 mL/minute); use not recommended in patients with severe renal impairment (Cl_cr <30 mL/minute).^{1 4 18}

IV

Should not be administered to patients with severe renal impairment (Cl_cr <30 mL/minute, S_cr >2.3 mg/dL).^{7 18}

Geriatric Patients

Dosage adjustments not necessary.^{1 7}

Cautions for Boniva

Contraindications

• 
  

  Uncorrected hypocalcemia.^{1 5 7 8}

  
  

  Known hypersensitivity to ibandronate or any ingredient in the formulation.^{1 5 7 8}

  
  


• 
  

  Oral: Inability to stand or sit upright for ≥60 minutes.^{1 5}

  
  

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.

GI Effects

Adverse upper GI effects (e.g., dysphagia, esophagitis, esophageal or gastric ulcer) reported with oral bisphosphonates.^{1 2} (See Administration under Dosage and Administration.)

Route of Administration

Injection must be administered IV by a health-care professional; do not administer by non-IV (e.g., intra-arterial) routes.⁷ (See Administration Risks under Dosage and Administration.)

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.

Renal Effects

Possible renal toxicity (e.g., deterioration of renal function and, rarely, renal failure) with bisphosphonates.^{7 12} Risk may be greater in patients with coexisting conditions associated with renal impairment, concomitant therapy with other nephrotoxic drugs, preexisting renal disease, dehydration, dosage, infusion volume and rate, and multiple cycles of treatment.^{4 7 8 9 10 11}

Use not recommended in patients with severe renal impairment (S_cr >2.3 mg/dL or Cl_cr <30 mL/minute).^{1 7}

Assess risk factors predisposing patients to renal deterioration.^{7 8} Measure S_cr prior to each IV dose.⁷ Withhold treatment if deterioration of renal function occurs.⁷

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 reported in patients receiving bisphosphonates.^{1 7 13} Most cases associated with dental procedures (e.g., tooth extraction) in cancer patients, but some have occurred in patients with postmenopausal osteoporosis or other diagnoses.^{1 7 13}

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).^{13 18} Such patients should avoid invasive dental procedures, if possible, during therapy.^{13 18}

Severe, occasionally incapacitating bone, joint, and/or muscle pain reported infrequently with bisphosphonate therapy.^{1 5 7 8 18} Time to onset of symptoms varied from 1 day to several months after treatment initiation.^{1 7 8} Such pain generally improves following discontinuance of the drug, but may recur upon subsequent rechallenge with the same drug or another bisphosphonate.^{1 5 7 8 18}

Metabolic Effects

Correct hypocalcemia, hypovitaminosis D, and other disturbances of bone and mineral metabolism before initiating therapy.^{1 7 8 18}

Oral: If daily intake inadequate, administer supplemental calcium and vitamin D.^{1 18 a}

IV: May cause a transient decrease in serum calcium concentrations.⁷ Supplemental calcium and vitamin D required regardless of the adequacy of dietary intake of calcium and vitamin D.^{7 18}

Specific Populations

Pregnancy

Category C. ^{1 7}

Lactation

Distributed into milk in rats; not known whether distributed into human milk.^{1 7} Use caution.^{1 7}

Pediatric Use

Safety and efficacy not established in children.^{1 7 18} Not indicated for use in children.¹⁸

Geriatric Use

No substantial differences in safety and efficacy relative to younger adults, but increased sensitivity cannot be ruled out.^{1 7} Consider age-related decreases in renal function.¹⁸

Renal Impairment

Oral: Use not recommended in patients with severe renal impairment (CL_cr <30 mL/minute).^{1 18}

IV: Do not administer in patients with severe renal impairment (Cl_cr <30 mL/minute, S_cr >2.3 mg/dL).^{7 18}

Common Adverse Effects

Oral: Upper respiratory infection,¹ back pain,¹ dyspepsia,^{1 2 a} bronchitis,¹ pain in the extremities,^{1 a} abdominal pain,¹ diarrhea,^{1 a} headache,¹ hypertension,¹ pneumonia,¹ myalgia,¹ arthralgia,¹ urinary tract infection,¹ nausea.¹

IV: Arthralgia,^{7 8 16 17} back pain,⁷ hypertension,⁷ abdominal pain.⁷

Interactions for Boniva

Does not induce or inhibit CYP isoenzymes (i.e., CYP1A2, 2A6, 2C9, 2C19, 2D6, 2E1, or 3A4)^{4 7} and is not metabolized.^{1 4 7}

Antacids or Mineral Supplements Containing Divalent Cations

Pharmacokinetic interaction (decreased absorption of ibandronate) when tablets are used concomitantly with antacids or mineral supplements containing divalent cations (e.g., aluminum, calcium, magnesium, iron).^{1 5 b} Administer tablets ≥60 minutes prior to such drugs or supplements.^{1 5}

Drugs Affecting Hepatic Microsomal Enzymes

Pharmacokinetic interactions unlikely.¹

Drugs Excreted through Renal Tubular Transport

Based on limited data in animals, not excreted through renal tubular transport.^{1 4 7} Pharmacokinetic interaction unlikely.^{1 4}

Nephrotoxic Agents

Potential pharmacologic interaction (increased risk of renal toxicity). ^{4 7 8 9 10 11 12} Assess patients taking concomitant nephrotoxic agents.^{1 7} (See Renal Effects under Cautions.)

Specific Drugs and Tests

Drug	Interaction	Comments
Bone-imaging agents	Potential to interfere with use of bone-imaging agents1 7
Histamine H2-receptor antagonists	Increased oral bioavailability of ibandronate1 4 b No evidence of increased adverse upper GI effects1 18	Not considered clinically important1 4
Melphalan	Pharmacokinetic interaction unlikely with IV ibandronate7
NSAIAs	No evidence of increased adverse upper GI effects1	Use concomitantly with caution1
Prednisolone	Pharmacokinetic interaction unlikely with IV ibandronate7
Tamoxifen	Pharmacokinetic interaction unlikely with IV ibandronate1 7

Boniva Pharmacokinetics

Absorption

Bioavailability

Absolute (compared with IV administration) oral bioavailability about 0.6%.^{1 4 16}

Onset

Reduction in bone turnover evident within 1–3 months of treatment initiation; maximal effects observed at 6 months.^{1 7 b}

Duration

Biochemical markers of bone turnover returned to baseline ≥12 months after treatment discontinuance.^b

Food

Bioavailability decreased by 90% when administered with a standard breakfast compared with administration under fasting conditions.¹ Bioavailability and effect on BMD reduced when food and beverages taken <60 minutes following oral administration.¹

Special Populations

In patients with renal impairment (Cl_cr 40–70 mL/minute), AUC is increased by 55% compared with that in patients with normal renal function (Cl_cr >90 mL/minute).⁷ Patients with severe renal impairment (Cl_cr <30 mL/minute) had >2-fold increase in AUC compared with exposure for healthy individuals.^{7 b}

Distribution

Extent

Widely distributed throughout the body and redistributed to bone.^{4 b} Subsequently, the drug is released systemically via bone turnover.^{1 4} Not known whether distributed into milk.⁷

Plasma Protein Binding

84–99.5% at therapeutic drug concentrations.^{1 4 7 b}

Elimination

Metabolism

No evidence of metabolism.^{7 16}

Elimination Route

Excreted in urine (50–60% of circulating dose) as unchanged drug and in feces (unabsorbed drug).^{1 4 7 b}

Half-life

Apparent oral terminal half-life is 37–157 hours; dose-dependent.¹

Apparent IV terminal half-life is 4.6–25.5 hours; dose-dependent.⁷

Special Populations

No race-related pharmacokinetic differences between Asians and whites; other races not studied.^b Pharmacokinetics not affected by gender.^{1 b}

Pharmacokinetics not evaluated in pediatric patients.^{1 b} Pharmacokinetics in patients with hepatic impairment not studied as ibandronate is not metabolized in the liver.¹

Stability

Storage

Oral

Tablets

25°C (may be exposed to 15–30°C).¹

Parenteral

Injection

25°C (may be exposed to 15–30°C).⁷

Compatibility

For information on systemic interactions resulting from concomitant use, see Interactions.

Parenteral

Do not admix with calcium-containing solutions or other IV drugs.⁷

Actions

• 
  

  Incorporates into bone and selectively inhibits osteoclast-mediated bone resorption in a dose-dependent manner.^{1 4 7 b}

  
  


• 
  

  Reduces biochemical markers of bone resorption in patients with postmenopausal osteoporosis.^{1 7 b}

  
  


• 
  

  Maintains or increases BMD^{2 3 13} and increases bone mass in postmenopausal women.^{1 4 5 7}

  
  

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 providing patient with a copy of the manufacturer’s patient information.^{1 7}

  
  


• 
  

  Importance of adhering to recommended life-style modifications (e.g., exercise, calcium and vitamin D supplementation).^{1 5}

  
  


• 
  

  Importance of correct oral administration (e.g., avoiding foods and beverages other than plain water [including mineral water] prior to administration, not lying down for ≥60 minutes following administration).^{1 5 18} (See GI Effects under Cautions.)

  
  


• 
  

  Importance of not taking vitamins, calcium, or antacids ≤60 minutes of taking oral ibandronate.^{1 5}

  
  


• 
  

  Necessity of swallowing tablets whole, without chewing or sucking.^{1 5}

  
  


• 
  

  Importance of reviewing how to resume therapy in the event of a missed dose.^{1 5 7}

  
  


• 
  

  Importance of discontinuing oral ibandronate and informing clinician if symptoms of esophageal disease (e.g., new or worsening dysphagia, difficulty or pain on swallowing, retrosternal pain, heartburn) develop.^{1 5}

  
  


• 
  

  Importance of informing a clinician if severe bone pain, joint pain, muscular pain, or jaw problems develop.^{8 a}

  
  


• 
  

  Importance of women informing clinicians if they are or plan to become pregnant or to plan to breast-feed.^{1 5 8}

  
  


• 
  

  Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs (vitamins, supplements, antacids), as well as any concomitant illnesses (e.g., preexisting dysphagia, esophageal disorders, renal impairment).^{1 5 8}

  
  


• 
  

  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.

Ibandronate Sodium

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Tablets, film-coated	2.5 mg (of ibandronate)	Boniva (with povidone)	Roche (also promoted by GlaxoSmithKline)
		150 mg (of ibandronate)	Boniva (with povidone)	Roche (also promoted by GlaxoSmithKline)
	Injection, for IV use only	1 mg (of ibandronate) per mL	Boniva (available in prefilled syringe with needle and swabs)	Roche (also promoted by GlaxoSmithKline)

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.

Boniva 150MG Tablets (GENENTECH): 1/$128.99 or 3/$372.99

Boniva 3MG/3ML Kit (GENENTECH): 3/$469.97 or 9/$1,329.91

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.

References

1. Roche Laboratories. Boniva (ibandronate sodium) tablets prescribing information. Nutley, NJ; 2006 Aug.

2. McClung MR, Wasnich RD, Recker R et al. Oral daily ibandronate prevents bone loss in early postmenopausal women without osteoporosis. J Bone Miner Res. 2004; 19:11-8. [PubMed 14753731]

3. Chesnut CH, Skag A, Christiansen C et al. Effect of oral ibandronate administered daily or intermittently on fracture risk in postmenopausal osteoporosis. J Bone Miner Res. 2004; 19:1241-9. [PubMed 15231010]

4. Barrett J, Worth E, Bauss F et al. Ibandronate: a clinical pharmacological and pharmacokinetic update. J Clin Pharmacol. 2004; 44:951-65. [IDIS 519745] [PubMed 15317823]

5. Roche Laboratories. Boniva (ibadronate sodium) tablets patient information. Nutley, NJ; 2005 Mar.

6. National Osteoporosis Foundation. Physician’s guide to prevention and treatment of osteoporosis. Washington, DC; 2000. From National Osteoporosis Foundation website ().

7. Roche Pharmceuticals. Boniva (ibandronate sodium) injection prescribing information. Nutley, NJ; 2006 Jan.

8. Roche Pharmceuticals. Boniva (ibandronate sodium) injection patient information. Nutley, NJ; 2006 Jan.

9. 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]

10. Brown DL, Robbins R. Developments in the therapeutic applications of bisphosphonates. J Clin Pharmacol. 1999; 39:651-60. [IDIS 430233] [PubMed 10392318]

11. Cheer SM, Noble S. Zoledronic acid. Drugs. 2001; 61:799-805. [PubMed 11398911]

12. 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]

13. Migliorati CA, Casiglia J, Epstein J et al. Managing the care of patients with bisphosphonate-associated osteonecrosis: an American Academy of Oral Medicine position paper. J Am Dent Assoc. 2005; 136:1658-68. [PubMed 16383047]

14. Novartis. Zometa (zoledronic acid) injection prescribing information. East Hanover, NJ; 2005 Apr.

15. Reginster JY, Adami S, Lakatos P et al. Efficacy and tolerability of once-monthy oral ibandronate in postmenopausal osteoporosis: 2 year results from the MOBILE study. Ann Rheum Dis [serial online]. January 26, 2006. Available at .

16. Reginster JY. Oral and intravenous ibandronate in the management of postmenopausal osteoporosis: a comprehensive review. Curr Pharm Des. 2005; 11:3711-28. [PubMed 16305506]

17. Delmas PD, Adami S, Strugala C et al. Intravenous ibandronate injections in postmenopausal women with osteoporosis: one-year results form the dosing intravenous administration study. Arthritis Rheum. 2006; 54:1838-46. [PubMed 16729277]

18. Roche Pharmaceuticals, Nutley, NJ: Personal communication.

a. Roche Laboratories. Boniva (ibadronate sodium) tablets patient information. Nutley, NJ; 2006 Aug.

b. Kehoe T, Colman E. Boniva (Ibandronate sodium) FDA approval package, Medical review. NDA No. 21-455. Rockville, MD; 2003 May 16.

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