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Ibandronate (Ibandronate Sodium) - Summary



Ibandronate sodium is a nitrogen-containing bisphosphonate that inhibits osteoclast-mediated bone resorption.

Ibandronate sodium is indicated for the following:

Treatment of Postmenopausal Osteoporosis

Ibandronate Sodium Injection is indicated for the treatment of osteoporosis in postmenopausal women. In postmenopausal women with osteoporosis, ibandronate sodium increases bone mineral density (BMD) and reduces the incidence of vertebral fractures [see Clinical Studies].

Important Limitations of Use

The safety and effectiveness of Ibandronate Sodium Injection for the treatment of osteoporosis are based on clinical data of one year duration. The optimal duration of use has not been determined. All patients on bisphosphonate therapy should have the need for continued therapy re-evaluated on a periodic basis. Patients at low-risk for fracture should be considered for drug discontinuation after 3 to 5 years of use. Patients who discontinue therapy should have their risk for fracture re-evaluated periodically.

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Published Studies Related to Ibandronate

Effect of ibandronate on spontaneous osteonecrosis of the knee: a randomized, double-blind, placebo-controlled trial. [2014]
diagnosed ON... CONCLUSIONS: In patients with spontaneous osteonecrosis of the knee,

The utility of changes in serum levels of C-terminal telopeptide of type I collagen in predicting patient response to oral monthly ibandronate therapy. [2010]
Bone turnover markers may provide a more rapid indication of patient response to osteoporosis treatment than bone mineral density (BMD) measurements. This post hoc analysis of data from the MOBILE (Monthly Oral iBandronate In LadiEs) study assessed the relationship between increases in BMD at 12 mo from baseline after starting ibandronate treatment and changes in bone resorption marker serum C-terminal telopeptide of type I collagen (sCTX) from baseline at 3 and 6 mo...

Efficacy and safety of monthly ibandronate in men with low bone density. [2010]
low bone density... CONCLUSIONS: In men with low BMD, 1 year of treatment with oral once-monthly

Risk reduction of non-vertebral fractures with intravenous ibandronate: post-hoc analysis from DIVA. [2010]
performed using DIVA study individual patient data... CONCLUSIONS: A significant effect on non-vertebral fracture risk reduction was

Effects of intermittent intravenous ibandronate injections on bone quality and micro-architecture in women with postmenopausal osteoporosis: the DIVA study. [2010]
In the Dosing IntraVenous Administration (DIVA) study, IV ibandronate injections (15-30 s duration) provided significantly greater gains in bone mineral density than daily oral ibandronate (P<0.001). Single transiliac bone biopsy was performed in a subgroup of women (n=109/1395) from DIVA to assess the impact of ibandronate on newly formed bone and bone remodeling...

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Clinical Trials Related to Ibandronate

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.

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

Study To Investigate Patient Preference On Dosing In Ibandronate And Risedronate In Korean Women With Postmenopausal Osteoporosis [Completed]
This is a randomized open label, multi-centre study for Korean women with postmenopausal osteoporosis, evaluating the preference for either the once-monthly dosing of ibandronate or the once-weekly dosing of risedronate. Eligible subjects will be randomised either ibandronate monthly regimen or risedronate weekly regimen. Treatment period consists of 3 month with ibandronate 150mg and additional 12 week with risedronate 35 mg or vice versa. After taking the first interventional medicine for 3 months or 12 weeks completely, a subject changes the treatment arm. There is no washout period.

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.

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Page last updated: 2015-08-10

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