RxPRODUCT NEWS: PROFILE: Boniva (ibandronate)

Boniva (ibandronate) has receivedFDA approval for the treatmentand prevention of postmenopausalosteoporosis. Marketed by Glaxo-SmithKline and Roche Pharmaceuticals,Boniva is the first chronicmedication ever to be approved foronce-a-month dosing.¹ Boniva is availableas 2.5 mg for once-daily dosingand as 150 mg for once-a-month dosing.Once-monthly treatment is expectedto increase compliance and conveniencefor patients.

Osteoporosis results from decreasedbone mass, especially in the hip, spine,and wrist.² The prevalence of the diseasein the United States has promptedthe surgeon general to declare osteoporosisa public health threat.¹ About40% of postmenopausal women >50years old will suffer from an osteoporosis-related fracture.² Althoughpostmenopausal women are at greatestrisk, osteoporosis affects both genders.An estimated 10 million people in theUnited States have osteoporosis today,and approximately 34 million othershave decreased bone mass-an increasedrisk of developing osteoporosis.Complications of osteoporosisinclude fractures, pain, hospitalization,and death.¹

Pharmacology

Boniva is a bisphosphonate. It inhibitsosteoclast bone resorption activity,resulting in increased bone turnoverand an increase in bone mass.²

Clinical Trials

A randomized, double-blind, placebo-controlled, multinational study of2946 postmenopausal women assessedthe safety and efficacy of once-dailyBoniva. Boniva 2.5 mg was given dailyto women aged 55 to 90 years. Allstudy participants received 400 internationalunits of vitamin D and 500mg of calcium daily. Over the 3-yearstudy, Boniva was shown to reduce therisk of new vertebral fractures; the fracturerisk in the Boniva group was loweredto 4.7%, while risk in the placebogroup was 9.6%. Treatment with Bonivaalso was shown to increase bonemineral density (BMD) significantlymore than placebo in the lumbarspine, hip, femoral neck, and trochanter.²

Treatment with once-monthly Bonivawas evaluated in a randomized,double-blind, multinational, non-inferioritytrial of 1602 postmenopausalwomen. Women aged 54 to 81 yearswere randomized to receive eitheronce-monthly Boniva 100 mg or 150mg or daily Boniva 2.5 mg. The once-monthlyregimen with 150 mg wasshown to be comparable to the daily2.5-mg treatment and resulted in higherBMD values overall.²

The prevention study assessed therole of Boniva in postmenopausalwomen with decreased BMD that hadnot yet progressed to osteoporosis. Arandomized, double-blind, placebo-controlled2-year study in womenwithout osteoporosis aged 41 to 82years compared daily treatment withBoniva 0.5 mg, 1 mg, and 2.5 mg. Allwomen received 500 mg of calciumsupplementation daily. Over the 2years, BMD was shown to increase significantlyin the Boniva 2.5-mg treatmentgroup, thus preventing the onsetof osteoporosis.²

Safety

Boniva is contraindicated in womenwith uncorrected hypocalcemia or inwomen unable to sit or stand uprightfor at least 60 minutes. Patients with acreatinine clearance <30 mL/minshould not use Boniva. Oral treatmentwith bisphosphonates has been linkedto gastrointestinal disorders such asdysphagia, esophagitis, and esophagealor gastric ulcers. Jaw osteonecrosishas developed in some patients usingbisphosphonates.²

The most commonly reported sideeffects include abdominal pain, hypertension,dyspepsia, arthralgia, nausea,and diarrhea.¹

Administration

Patients should swallow Bonivatablets whole with a full glass of plainwater at least 60 minutes before thefirst food, drink, or medication of theday. They must remain upright for afull 60 minutes after taking the dose.²Boniva should be taken on the sameday each month. If a dose is missedand the next scheduled Boniva dose is>7 days away, patients should take 1Boniva tablet the morning after theyremember. If the next scheduled Bonivadose is <7 days away, patientsshould wait until the next scheduleddate to take their tablet. Patientsshould never take two 150-mg Bonivatablets in the same week.² Additionalcalcium and vitamin D supplementationmay be warranted during Bonivatherapy.²

Dr. Holmberg is a pharmacist with PhoenixChildren's Hospital, Phoenix, Ariz.

For a list of references, send astamped, self-addressed envelope to:References Department, Attn. A. Stahl,Pharmacy Times, 241 Forsgate Drive,Jamesburg, NJ 08831; or send an e-mailrequest to: astahl@ascendmedia.com.