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Boniva Injection (Ibandronate Sodium) - Summary



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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Media Articles Related to Boniva Injection (Ibandronic Acid)

Osteoporosis Quiz: What is Osteoporosis?
Source: MedicineNet Hormone Therapy Specialty [2017.04.20]
Title: Osteoporosis Quiz: What is Osteoporosis?
Category: MedicineNet Quiz
Created: 1/14/2011 12:00:00 AM
Last Editorial Review: 4/20/2017 5:56:50 PM

Value of Osteoporosis Drugs Uncertain in Patients With CKD
Source: Medscape Nephrology Headlines [2017.04.18]
The benefits and harms of drugs used to treat osteoporosis in patients with chronic kidney disease are still uncertain, according to a systemic review and meta-analysis of the literature.
Medscape Medical News

Benefits and harms of osteoporosis medications unclear for patients with CKD
Source: Bones / Orthopedics News From Medical News Today [2017.04.11]
More research is needed to determine the benefits and harms of osteoporosis medications on bone mineral density (BMD), fracture risk, and safety among patients with chronic kidney disease (CKD).

Potential early warning signs of osteoporosis found in South Asian women
Source: Bones / Orthopedics News From Medical News Today [2017.03.23]
Pre-menopausal South Asian women could be more at risk of developing osteoporosis in later life than white Caucasian women, a new study in the Journal Bone reports.

Osteoporosis drug found safe in long-term trial
Source: Bones / Orthopedics News From Medical News Today [2017.03.21]
A new study provides reassuring information about the short-term and long-term safety of denosumab, a monoclonal antibody that is used to treat postmenopausal osteoporosis.

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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.

Oral ibandronic acid versus intravenous zoledronic acid in treatment of bone metastases from breast cancer: a randomised, open label, non-inferiority phase 3 trial. [2014]
the treatment of metastatic breast cancer to bone... INTERPRETATION: Our results suggest that zoledronic acid is preferable to

Bioequivalence study of two formulations of ibandronic acid 150-mg film-coated tablets in healthy volunteers under fasting conditions: a randomized, open-label, three-way, reference-replicated crossover study. [2014]
Bonviva(®)... CONCLUSIONS: Test formulation of ibandronic acid is bioequivalent in rate and

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.

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Clinical Trials Related to Boniva Injection (Ibandronic Acid)

Bioequivalence Study of Ibandronate Sodium Tablets 150 mg Under Fasting Condition [Completed]
This is an open label, randomised, balanced, two-treatment, two-period, two-sequence, crossover, oral bioequivalence study.

PTH & Ibandronate Combination Study (PICS) [Completed]
This study will test in several innovative ways, several different combinations of PTH and oral monthly ibandronate for the treatment of osteoporosis in postmenopausal women. The intension is to provide other options for treatment than the current standard 2 year course of drug therapy. These options may lead to treatment where the two years of therapy are spread over several years.

A Study Comparing Monthly Bonviva (Ibandronate) and Weekly Risedronate in Women With Post-Menopausal Osteoporosis. [Completed]
This 2-sequence crossover study will evaluate patient reported preference for once-monthly ibandronate (150 mg orally) as opposed to once-weekly risedronate (35 mg orally). Participants with post-menopausal osteoporosis will be randomized to receive one product for three months (12 weeks). They will then cross over to receive the other treatment for three months (12 weeks). The anticipated time on study treatment is 6 months (plus a 15-day follow up period), and the target sample size is 100-500 individuals.

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

Study Comparing Ibandronate Versus Placebo in Hip Osteonecrosis [Recruiting]
Aseptic osteonecrosis of the hip (AOH) concern 1 Swiss young adult to 1000 (30-40 years old). They are responsible to a severe joint destruction and in the majority of cases a joint replacement. To the hip, we can distinguish 4 stages of osteonecrosis according to Ficat: 1, 2, 3, 4. Stage 3 and 4 AOH management are unanimous surgical. But management of stage 1 and 2 are unclear. Bisphophonates are mainly used for bone and osteoporosis diseases. They decrease the bone turn over, and the risk of fracture. They also decrease the bone marrow oedema and the pain associated to this oedema. Ibandronate is a bisphosphonate with a rapid effect, a short half-life, easy to manage, and with few side effects. We designed a double-blind prospective randomized trial aiming to evaluate the efficacy of an infusion of ibandronate versus placebo on pain and AOH progression in patients with stage 1 and 2 AOH. Our hypothesis is that there will be a pain reduction >=20 mm on the VAS scale (SD 10mm) in the ibandronate group versus placebo, and a non radiological progression in the treated group.

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Page last updated: 2017-04-20

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