/publications/issue/2005/2005-06/2005-06-9647

RxPRODUCT NEWS: PROFILE: Boniva (ibandronate)

Author: Monica Holmberg, PharmD

Boniva (ibandronate) has received FDA approval for the treatment and prevention of postmenopausal osteoporosis. Marketed by Glaxo- SmithKline and Roche Pharmaceuticals, Boniva is the first chronic medication ever to be approved for once-a-month dosing.1 Boniva is available as 2.5 mg for once-daily dosing and as 150 mg for once-a-month dosing. Once-monthly treatment is expected to increase compliance and convenience for patients.

Osteoporosis results from decreased bone mass, especially in the hip, spine, and wrist.2 The prevalence of the disease in the United States has prompted the surgeon general to declare osteoporosis a public health threat.1 About 40% of postmenopausal women >50 years old will suffer from an osteoporosis-related fracture.2 Although postmenopausal women are at greatest risk, osteoporosis affects both genders. An estimated 10 million people in the United States have osteoporosis today, and approximately 34 million others have decreased bone mass-an increased risk of developing osteoporosis. Complications of osteoporosis include fractures, pain, hospitalization, and death.1

Pharmacology

Boniva is a bisphosphonate. It inhibits osteoclast bone resorption activity, resulting in increased bone turnover and an increase in bone mass.2

Clinical Trials

A randomized, double-blind, placebo-controlled, multinational study of 2946 postmenopausal women assessed the safety and efficacy of once-daily Boniva. Boniva 2.5 mg was given daily to women aged 55 to 90 years. All study participants received 400 international units of vitamin D and 500 mg of calcium daily. Over the 3-year study, Boniva was shown to reduce the risk of new vertebral fractures; the fracture risk in the Boniva group was lowered to 4.7%, while risk in the placebo group was 9.6%. Treatment with Boniva also was shown to increase bone mineral density (BMD) significantly more than placebo in the lumbar spine, hip, femoral neck, and trochanter.2

Treatment with once-monthly Boniva was evaluated in a randomized, double-blind, multinational, non-inferiority trial of 1602 postmenopausal women. Women aged 54 to 81 years were randomized to receive either once-monthly Boniva 100 mg or 150 mg or daily Boniva 2.5 mg. The once-monthly regimen with 150 mg was shown to be comparable to the daily 2.5-mg treatment and resulted in higher BMD values overall.2

The prevention study assessed the role of Boniva in postmenopausal women with decreased BMD that had not yet progressed to osteoporosis. A randomized, double-blind, placebo-controlled 2-year study in women without osteoporosis aged 41 to 82 years compared daily treatment with Boniva 0.5 mg, 1 mg, and 2.5 mg. All women received 500 mg of calcium supplementation daily. Over the 2 years, BMD was shown to increase significantly in the Boniva 2.5-mg treatment group, thus preventing the onset of osteoporosis.2

Safety

Boniva is contraindicated in women with uncorrected hypocalcemia or in women unable to sit or stand upright for at least 60 minutes. Patients with a creatinine clearance <30 mL/min should not use Boniva. Oral treatment with bisphosphonates has been linked to gastrointestinal disorders such as dysphagia, esophagitis, and esophageal or gastric ulcers. Jaw osteonecrosis has developed in some patients using bisphosphonates.2

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

Administration

Patients should swallow Boniva tablets whole with a full glass of plain water at least 60 minutes before the first food, drink, or medication of the day. They must remain upright for a full 60 minutes after taking the dose.2 Boniva should be taken on the same day each month. If a dose is missed and the next scheduled Boniva dose is >7 days away, patients should take 1 Boniva tablet the morning after they remember. If the next scheduled Boniva dose is <7 days away, patients should wait until the next scheduled date to take their tablet. Patients should never take two 150-mg Boniva tablets in the same week.2 Additional calcium and vitamin D supplementation may be warranted during Boniva therapy.2

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

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