Boniva (Ibandronate Sodium) - Summary

BONIVA SUMMARY

BONIVA^®
(ibandronate sodium)
TABLETS

BONIVA (ibandronate sodium) is a nitrogen-containing bisphosphonate that inhibits osteoclast-mediated bone resorption.

BONIVA is indicated for the treatment and prevention of osteoporosis in postmenopausal women.

Treatment of Postmenopausal Osteoporosis

In postmenopausal women with osteoporosis, BONIVA increases BMD and reduces the incidence of vertebral fractures (see CLINICAL STUDIES). Osteoporosis may be confirmed by the presence or history of osteoporotic fracture or by a finding of low bone mass (BMD more than 2 standard deviations below the premenopausal mean [ie, T-score]).

Prevention of Postmenopausal Osteoporosis

BONIVA may be considered in postmenopausal women who are at risk of developing osteoporosis and for whom the desired clinical outcome is to maintain bone mass and to reduce the risk of fracture.

Factors such as family history of osteoporosis, early menopause, previous fracture, high bone turnover, reduced BMD (at least 1.0 SD below the premenopausal mean), thin body frame, Caucasian or Asian race, and smoking, are associated with an increased risk of developing osteoporosis and fractures. The presence of these risk factors may be important when considering the use of BONIVA for preventing osteoporosis.

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BONIVA NEWS HIGHLIGHTS

Published Studies Related to Boniva (Ibandronic Acid)

Patient preference for once-monthly ibandronate versus once-weekly alendronate in a randomized, open-label, cross-over trial: the Boniva Alendronate Trial in Osteoporosis (BALTO). [2005.12]
CONCLUSIONS: Significantly more women with postmenopausal osteoporosis preferred once-monthly ibandronate therapy to once-weekly alendronate therapy, and found the once-monthly regimen to be more convenient. Ease of following a treatment regimen for a long time was the most common reason given for the patients' preferences.

Oral versus intravenous ibandronic acid: a comparison of treatment options for metastatic bone disease. [2008.12]
PURPOSE: This trial is the first to compare directly the clinical response to and safety of oral and intravenous (IV) ibandronic acid [generic for Boniva] for metastatic bone disease... CONCLUSION: Oral and IV ibandronic acid for bone metastases have similar efficacy and tolerability.

Managing neoplastic bone disease with ibandronic acid: a preclinical and clinical data update. [2008.12]
CONCLUSIONS: Ibandronate remains the only bisphosphonate with approved oral and intravenous formulations; ibandronate should be considered when designing a bisphosphonate-containing regimen for patients with bone metastases from breast cancer.

Oral versus intravenous ibandronic acid: a comparison of treatment options for metastatic bone disease. [2008.05.27]
PURPOSE: This trial is the first to compare directly the clinical response to and safety of oral and intravenous (IV) ibandronic acid [generic for Boniva] for metastatic bone disease... CONCLUSION: Oral and IV ibandronic acid for bone metastases have similar efficacy and tolerability.

Long-term safety of intravenous ibandronic acid for up to 4 years in metastatic breast cancer: an open-label trial. [2006]
BACKGROUND AND OBJECTIVE: Despite their widespread use in metastatic bone disease, some bisphosphonate drugs are associated with adverse events (AEs), particularly renal toxicity, adding to treatment burdens and increasing healthcare costs. Ibandronic acid [generic for Boniva] is a single-nitrogen bisphosphonate with high efficacy against bone events and metastatic bone pain, and a renal safety profile compar- able to that of placebo. In this study, the safety of ibandronic acid was examined over a period of 4 years... CONCLUSION: This 96-week open-label safety extension of a phase III, placebo-controlled trial demonstrates that long-term use of intravenous ibandronic acid is well tolerated.

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Clinical Trials Related to Boniva (Ibandronic Acid)

BONCURE Study: A Study of Monthly Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis on Bisphosphonate Therapy. [Active, not recruiting]
This single arm study will assess patient preference for monthly Bonviva, versus daily or weekly alendronate or risedronate, in the treatment of postmenopausal osteoporosis. Patients currently on a daily or weekly regimen of bisphosphonate therapy (alendronate or risedronate) will answer a questionnaire to identify patients who may benefit from a monthly Bonviva regimen. Eligible patients will then discontinue their present bisphosphonate treatment, and switch to monthly Bonviva 150mg po. At the beginning and end of Bonviva treatment, all patients will complete an Osteoporosis Patient Satisfaction Questionnaire. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.

A Study of Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis Previously Treated With Bonviva [Completed]
This 2 arm study will assess the long-term efficacy and safety of oral treatment with 100mg or 150mg Bonviva in women with post-menopausal osteoporosis who have previously completed Bonviva study BM16549 (MOBILE study). Patients will receive Bonviva either 100mg po monthly, or 150mg po monthly. Patients will also receive daily supplementation with vitamin D and calcium. The anticipated time of study treatment is 2+ years, and the target sample size is 500+ individuals.

BEATRIS Study: A Study of Adherence to Bonviva (Ibandronate) Once Monthly in Women With Post-Menopausal Osteoporosis [Active, not recruiting]
This 2 arm study will assess the impact of Bone Marker Feedback (BMF), using blood sampling and communication of the results at 2 months, on adherence to monthly Bonviva (150mg po) in women with post-menopausal osteoporosis. Patients will be randomized into either 1) a group which receives bone marker feedback or 2)a group which does not receive feedback on the results. The study will also assess patient satisfaction with treatment with once monthly Bonviva. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.

SUMMIT Study: A Study of Persistence to Bonviva (Ibandronate) Once Monthly in Women With Post-Menopausal Osteoporosis. [Active, not recruiting]
This 2 arm study will assess the impact of bone marker feedback, using blood sampling and communication of results at week 5, on persistence to monthly Bonviva (150mg po) in women with post-menopausal osteoporosis. The study will also assess safety, quality of life and patient satisfaction. All patients will receive Bonviva 150mg po monthly, and will be randomized into the bio-feedback or no bio-feedback study arms. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.

A Study Comparing Monthly Boniva (Ibandronate) and Weekly Risedronate in Women With Post-Menopausal Osteoporosis. [Active, not recruiting]
This 2 arm crossover study will evaluate patient reported preference for either once monthly Boniva (150mg p. o.) or once weekly risedronate (35mg p. o.). Patients with post-menopausal osteoporosis will be randomized to receive Boniva for 3 calendar months or risedronate for 12 weeks; they will then cross over to receive the alternative treatment for a further 12 weeks/3 months. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

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