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Boniva (Ibandronate Sodium) - Summary



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

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Treatment and Prevention of Postmenopausal Osteoporosis

BONIVA is indicated for the treatment and prevention of osteoporosis in postmenopausal women. BONIVA increases bone mineral density (BMD) and reduces the incidence of vertebral fractures.

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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 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.

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.

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Clinical Trials Related to Boniva (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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Reports of Suspected Boniva (Ibandronic Acid) Side Effects

Femur Fracture (986)LOW Turnover Osteopathy (485)Fall (462)Anxiety (326)Osteoarthritis (318)Arthralgia (313)Gastrooesophageal Reflux Disease (245)Pain in Extremity (244)Hypertension (239)Tooth Disorder (226)more >>


Based on a total of 2 ratings/reviews, Boniva has an overall score of 2. The effectiveness score is 5 and the side effect score is 3. The scores are on ten point scale: 10 - best, 1 - worst.

Boniva review by 60 year old female patient

Overall rating:  
Effectiveness:   Considerably Effective
Side effects:   Severe Side Effects
Treatment Info
Condition / reason:   preventing osteoporosis
Dosage & duration:   150 mg taken once monthly for the period of 3 months
Other conditions:   none
Other drugs taken:   nothing regularly
Reported Results
Benefits:   Was to prevent thinning of bones
Side effects:   Nauseau, increasing in severity each time Boniva was taken. By the third month, even with waiting a couple of hours after taking the pill before any food was consumed, the food did not stay down at all. Before eating, it was like dry heaves and it was hoped food would alleviate those. It didn't work. Felt miserable for most of the rest of the day
Comments:   Take one Boniva once a month.


Boniva review by 59 year old male patient

Overall rating:  
Effectiveness:   Ineffective
Side effects:   Extremely Severe Side Effects
Treatment Info
Condition / reason:   osteoporosis
Dosage & duration:   250 mg taken once a mo for the period of once
Other conditions:   Liver transplant survivor
Other drugs taken:   Prograf, Cellcept, Fludrocortisone, occasional Vicodin
Reported Results
Benefits:   None. Due to side effects I was only able to take a single dose. I am now hoping that I do not have permanent damage from the single dose. Time will tell.
Side effects:   Extreme agonizing bone pain in neck and ribs; high fever for 1 1/2 days; debilitating pain in shoulder and neck to the point that I could not get out of bed for 4 days. I subsequently read that it can aggravate previous injuries where bones have been broken or damaged. I had an earlier neck injury and compression fractures in my spine. I believe these old injuries were antagonized by the Boniva.
Comments:   In order to counteract the side effects I took Benadryl for a possible allergic reaction and Prednisone to reduce inflammation. Had to take 2 Tylenol every 6 hours for pain. This drug has not had anywhere near enough testing. In the aftermath of my experience I have now heard for 4 seperate people that they know or heard of someone with a bad Boniva experience. This drug was once a solvent / cleaning product in industry. How on earth did it ever get fed to mammals to see the effect on bone loss / bone growth? I will never take it again, even if I wind up only 4 feet tall. It is a horrible drug.

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Page last updated: 2015-08-10

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