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Boniva (Ibandronate Sodium) - Summary

 
 



BONIVA SUMMARY

Treatment and Prevention of Postmenopausal Osteoporosis

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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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.

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.

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 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)

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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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 >>


PATIENT REVIEWS / RATINGS / COMMENTS

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

  Rating
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

  Rating
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: 2011-12-09

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