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Boniva Injection (Ibandronate Sodium) - Summary

 
 



SUMMARY

BONIVA®
(ibandronate sodium)
INJECTION

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

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

In postmenopausal women with osteoporosis, BONIVA increases BMD and reduces the incidence of vertebral fractures (see CLINICAL PHARMACOLOGY: 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 2.0 standard deviations below the premenopausal mean [ie, T-score]).


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NEWS HIGHLIGHTS

Media Articles Related to Boniva Injection (Ibandronic Acid)

Women, seniors with sleep apnea at greater risk for osteoporosis
Source: Respiratory / Asthma News From Medical News Today [2014.04.17]
A diagnosis of obstructive sleep apnea may raise the risk of osteoporosis, particularly among women or older individuals, according to a new study published in the Endocrine Society's Journal of...

Cell membrane repair may be impeded by osteoporosis drugs
Source: Bones / Orthopedics News From Medical News Today [2014.04.16]
A class of drugs widely used to treat osteoporosis appears to impede a cell's ability to repair a protective outer membrane that helps determine what enters and exits, researchers report.

Guidance to ensure safe and effective physical activity for osteoporosis patients
Source: Bones / Orthopedics News From Medical News Today [2014.04.08]
Experts from the Too Fit to Fracture Initiative presented the results of an international consensus process to establish exercise recommendations for people with osteoporosis, with or without spine...

Novel Osteoporosis Drug Could Change Treatment: Study
Source: MedicineNet alendronate Specialty [2014.01.03]
Title: Novel Osteoporosis Drug Could Change Treatment: Study
Category: Health News
Created: 1/2/2014 4:35:00 PM
Last Editorial Review: 1/3/2014 12:00:00 AM

Osteoporosis Drug Aids Young People With Cystic Fibrosis Not Helped By Standard Treatments
Source: Cystic Fibrosis News From Medical News Today [2013.06.06]
The first randomised trial to investigate the treatment of low bone density in young people with cystic fibrosis (CF), published Online First in The Lancet Respiratory Medicine, provides compelling...

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Published Studies Related to Boniva Injection (Ibandronic Acid)

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 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.

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.

Renal function changes and NHS resource use in breast cancer patients with metastatic bone disease treated with IV zoledronic acid or oral ibandronic acid: a four-centre non-interventional study. [2010.03]
AIMS: To describe renal function monitoring practice in patients with metastatic bone disease (MBD) treated with IV zoledronic acid (ZA) and oral ibandronic acid (IA), the management pathways and NHS hospital resources used... CONCLUSION: Although limited by retrospective design, these results demonstrate that in many patients, CrCl is not calculated before or during treatment with bisphosphonates. Renal function deteriorated in many patients during therapy. In view of these effects, practice should be reviewed to ensure appropriate dosing.

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 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.

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Clinical Trials Related to Boniva Injection (Ibandronic Acid)

BONVIVA(Ibandronate) PMS(Post-marketing Surveillance ) [Recruiting]

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.

BONVIVA(Ibandronate) Injection PMS(Post-marketing Surveillance) [Recruiting]

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.

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Page last updated: 2014-04-17

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