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.
