Boniva

Osteoporosis, Malignant Neoplasms, Bone Metastases + 1 more

Treatment

2 FDA approvals

20 Active Studies for Boniva

What is Boniva

Ibandronate

The Generic name of this drug

Treatment Summary

Ibandronate, also known as BM 21.0955, is a type of medication used to prevent and treat bone loss in postmenopausal women. It is a third-generation drug that is similar to zoledronic acid, minodronic acid and risedronic acid. Ibandronate has been used to treat bone loss in dogs since 1993, and it was approved by the FDA in 2003.

Boniva

is the brand name

image of different drug pills on a surface

Boniva Overview & Background

Brand Name

Generic Name

First FDA Approval

How many FDA approvals?

Boniva

Ibandronate

2005

24

Approved as Treatment by the FDA

Ibandronate, otherwise known as Boniva, is approved by the FDA for 2 uses which include Osteoporosis and Osteoporosis .

Osteoporosis

Helps manage Osteoporosis

Osteoporosis

Helps manage Osteoporosis

Effectiveness

How Boniva Affects Patients

Ibandronate is a medicine used to help prevent and treat osteoporosis in postmenopausal women. It is a relatively safe drug, and its effects can last a long time. Patients should be aware of the potential side effects such as stomach issues, low calcium, muscle pain, jaw damage, and kidney problems.

How Boniva works in the body

Bisphosphonates are taken into the body, where they bind to bone. This triggers the osteoclasts (cells that break down bone) to become acidic. This causes the bisphosphonates to be released from the bone and taken up by the osteoclasts. The bisphosphonates stop the osteoclasts from doing their job, which stops the bone from being broken down. Nitrogen containing bisphosphonates such as ibandronate also inhibit proteins that are important for cell survival. Without these proteins, cells die, causing tumor cells to die as well.

When to interrupt dosage

The advocated dosage of Boniva is contingent upon the diagnosed condition, including Bone Metastases, Malignant Neoplasms and Osteoporosis. The dose also fluctuates as per the method of delivery outlined in the table below.

Condition

Dosage

Administration

Malignant Neoplasms

, 3.0 mg/mL, 150.0 mg, 1.0 mg, 3.0 mg, 50.0 mg, 2.0 mg, 6.0 mg, 2.5 mg, 1.0 mg/mL

, Intravenous, Injection, solution, Injection, solution - Intravenous, Tablet, Tablet - Oral, Tablet, film coated, Tablet, film coated - Oral, Oral, Liquid, Liquid - Intravenous, Injection, solution, concentrate, Injection, solution, concentrate - Intravenous, Injection, Injection - Intravenous

Bone Metastases

, 3.0 mg/mL, 150.0 mg, 1.0 mg, 3.0 mg, 50.0 mg, 2.0 mg, 6.0 mg, 2.5 mg, 1.0 mg/mL

, Intravenous, Injection, solution, Injection, solution - Intravenous, Tablet, Tablet - Oral, Tablet, film coated, Tablet, film coated - Oral, Oral, Liquid, Liquid - Intravenous, Injection, solution, concentrate, Injection, solution, concentrate - Intravenous, Injection, Injection - Intravenous

Breast Cancer

, 3.0 mg/mL, 150.0 mg, 1.0 mg, 3.0 mg, 50.0 mg, 2.0 mg, 6.0 mg, 2.5 mg, 1.0 mg/mL

, Intravenous, Injection, solution, Injection, solution - Intravenous, Tablet, Tablet - Oral, Tablet, film coated, Tablet, film coated - Oral, Oral, Liquid, Liquid - Intravenous, Injection, solution, concentrate, Injection, solution, concentrate - Intravenous, Injection, Injection - Intravenous

Osteoporosis

, 3.0 mg/mL, 150.0 mg, 1.0 mg, 3.0 mg, 50.0 mg, 2.0 mg, 6.0 mg, 2.5 mg, 1.0 mg/mL

, Intravenous, Injection, solution, Injection, solution - Intravenous, Tablet, Tablet - Oral, Tablet, film coated, Tablet, film coated - Oral, Oral, Liquid, Liquid - Intravenous, Injection, solution, concentrate, Injection, solution, concentrate - Intravenous, Injection, Injection - Intravenous

Warnings

Boniva Contraindications

Condition

Risk Level

Notes

Esophageal Strictures

Do Not Combine

Hypocalcemia

Do Not Combine

Esophagus

Do Not Combine

Esophageal Achalasia

Do Not Combine

Orthostatic Intolerance

Do Not Combine

Severe Hypersensitivity Reactions

Do Not Combine

Ibandronate may interact with Pulse Frequency

There are 20 known major drug interactions with Boniva.

Common Boniva Drug Interactions

Drug Name

Risk Level

Description

Hydroxyzine

Major

The risk or severity of QTc prolongation can be increased when Ibandronate is combined with Hydroxyzine.

Mobocertinib

Major

The risk or severity of QTc prolongation can be increased when Ibandronate is combined with Mobocertinib.

Ziprasidone

Major

The risk or severity of QTc prolongation can be increased when Ibandronate is combined with Ziprasidone.

Abexinostat

Minor

The risk or severity of QTc prolongation can be increased when Ibandronate is combined with Abexinostat.

Aceprometazine

Minor

The risk or severity of QTc prolongation can be increased when Ibandronate is combined with Aceprometazine.

Boniva Toxicity & Overdose Risk

Signs of ibandronate overdose include low calcium and phosphorus levels, stomach pain, indigestion, esophagitis, and ulcers. To reduce the amount of unabsorbed drug, patients can drink milk or take antacids. Treatment for an ibandronate overdose includes providing intravenous electrolytes, and dialysis is not known to be effective in removing the drug from the bloodstream.

image of a doctor in a lab doing drug, clinical research

Boniva Novel Uses: Which Conditions Have a Clinical Trial Featuring Boniva?

At present, 729 active clinical trials are underway to ascertain the effectiveness of Boniva in ameliorating Bone Metastases, Malignant Neoplasms and Osteoporosis.

Condition

Clinical Trials

Trial Phases

Osteoporosis

25 Actively Recruiting

Not Applicable, Phase 4, Phase 1, Phase 2

Breast Cancer

25 Actively Recruiting

Phase 2, Not Applicable, Phase 3, Phase 1

Bone Metastases

6 Actively Recruiting

Not Applicable, Phase 4, Phase 3

Malignant Neoplasms

0 Actively Recruiting

Boniva Reviews: What are patients saying about Boniva?

5

Patient Review

11/2/2016

Boniva for Decreased Bone Mass Following Menopause

I've been on Boniva for four weeks now, and I'm happy to report that I haven't experienced any negative side effects.

2.3

Patient Review

4/12/2019

Boniva for Decreased Bone Mass Following Menopause

I haven't been able to tell if it's effective yet or not. I just took my third dose, and if it's anything like the first two doses, I won't be taking it again.

2

Patient Review

7/31/2021

Boniva for Decreased Bone Mass Following Menopause

I started taking Benlista a few days ago and have had some unpleasant side effects every day since then. Really terrible headaches, nausea, dizziness, and it's hard to swallow the pill. I would never recommend this medication to anyone.

1.7

Patient Review

5/31/2018

Boniva for Decreased Bone Mass Following Menopause

The flu-like symptoms I experienced while taking this medication for two months were not worth the treatment.

1.7

Patient Review

6/12/2021

Boniva for Decreased Bone Mass Following Menopause

I took this medicine two days ago and have been bedridden since. I'm experiencing pain all over my body at this point. There's no way I'm taking this again – the side effects are far worse than any potential benefits.

1.7

Patient Review

7/2/2022

Boniva for Decreased Bone Mass Following Menopause

The generic version of Bonita gave me some pretty bad side effects that I'm still feeling even days later. Tylenol has only been managing the pain, and it's been really rough. My doctor agreed that this isn't a medication worth taking again.

1.7

Patient Review

12/4/2018

Boniva for Decreased Bone Mass Following Menopause

After three months of taking this medication, I can say with certainty that I will not be continuing it for a fourth month. It has caused me immense pain in my fingers and legs, as well as severe hip joint pain.

1

Patient Review

12/10/2015

Boniva for Decreased Bone Mass Following Menopause

I was given this drug by my doctor and have been taking it for 12 years . I was only supposed to take it for two years, but my GP never informed me. I was suffering from a lot of bone pain--the pain in my feet was affecting my driving, hand pain, back pain. I stopped taking Boniva two months ago and all my pains have gone away. I feel so much better.... Pain free

1

Patient Review

4/22/2016

Boniva for Decreased Bone Mass Following Menopause

I took one Boniva pill on April 20th, and the next day I experienced incredibly painful symptoms in my arms, legs, and fingers. My vision was also blurred to the point where driving was not an option. Needless to say, I will not be taking this medication again.

1

Patient Review

8/9/2018

Boniva for Decreased Bone Mass Following Menopause

I had some side effects the first month, but nothing major. The second month was a different story--I experienced horrible pain, dizziness, and vomiting. There's no way I'm taking it for a third month!

1

Patient Review

3/8/2017

Boniva for Decreased Bone Mass Following Menopause

I would not recommend this medicine to anyone. The side effects are incredibly dangerous and potentially deadly--even before you have osteoporosis!

1

Patient Review

11/3/2016

Boniva for Decreased Bone Mass Following Menopause

I experienced horrible side effects that made me feel like I was hit by a truck. The pain was excruciating and widespread. I also had to go to the hospital because of disfiguring swelling in my face and neck. I would never recommend this treatment to anyone.

1

Patient Review

6/19/2018

Boniva for Decreased Bone Mass Following Menopause

I took one pill and the side effects were so bad that I decided it wasn't worth it, even if the treatment actually worked! My whole body was aching, especially my legs, arms, and fingers.

1

Patient Review

6/4/2022

Boniva for Decreased Bone Mass Following Menopause

I took the recommended dosage and within two hours, I was in immense pain with heartburn. I also had diarrhea, nausea, a headache, and felt cold. For three days after taking this medication, I was housebound because of how weak and fatigued it made me feel!

1

Patient Review

5/1/2022

Boniva for Post-Menopausal Osteoporosis Prevention

I followed the directions to a tee and started experiencing awful nausea and sharp abdominal pains. This continued on for weeks, including vomiting and gastritis. Save yourself the trouble and avoid this medication entirely.

1

Patient Review

7/12/2018

Boniva for Decreased Bone Mass Following Menopause

I've just started taking Ibandronate, which is the generic form of Boniva. So far there have been no side effects that I can tell. My pharmacist did suggest that I continue taking a supplement called OsteoBase in addition to the Ibandronate, so I'm doing that.

1

Patient Review

3/13/2022

Boniva for Decreased Bone Mass Following Menopause

I had extremely unpleasant gastrointestinal symptoms after taking just one pill. I'll be seeking an alternative from my doctor tomorrow.
image of drug pills surrounding a glass of water symbolizing drug consumption

Patient Q&A Section about boniva

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Why was Boniva taken off the market?

"Some people are worried about the possible risks of taking bisphosphonates (such as Boniva) for a long time. Some potential risks include atypical femur fractures, osteonecrosis of the jaw, and esophageal cancer."

Answered by AI

What is better Boniva or Fosamax?

"Although both Fosamax and Boniva have been shown to reduce the risk of fractures, Fosamax is generally recommended over Boniva because it is not clear whether Boniva is effective in reducing the risk of hip or nonvertebral fractures."

Answered by AI

How effective is Boniva for osteoporosis?

"After 2 years of treatment, the average spine BMD results were 3.1% to 4.12% better for women given Boniva than for those given a placebo, meaning Boniva is effective in preventing osteoporosis for postmenopausal women."

Answered by AI

What are the side effects from taking Boniva?

"The pill's most common side effects are diarrhea, pain in the extremities, and upset stomach. Its less common side effects may be pain or trouble swallowing, heartburn, and stomach ulcers."

Answered by AI

Clinical Trials for Boniva

Image of Clinical and Translational Science Center, Weill Cornell Medical College in New York, United States.

Treatment for Menopause

40 - 90
Female
New York, NY

This study will compare adherence, tolerability, safety, and treatment satisfaction between a calcium-rich food and a traditional calcium carbonate supplement in women ages 40 to 90 who are at increased risk for osteoporosis. Participants will be randomly assigned to receive either a calcium-rich food providing 500 mg of calcium from milk-derived minerals or a 500 mg calcium carbonate supplement once daily for four weeks. Participants will complete brief weekly questionnaires assessing supplement use, gastrointestinal symptoms, and treatment satisfaction. The goal of the study is to determine whether the form in which calcium is consumed influences adherence and participant experience. No blood draws, imaging studies, or other invasive procedures are involved

Waitlist Available
Has No Placebo

Clinical and Translational Science Center, Weill Cornell Medical College

Jeff Zhu

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Abemaciclib for Breast Cancer

18+
Female
Burlington, VT

Abemaciclib (Verzenio) is a commonly used treatment for hormone receptor-positive breast cancer, but it can cause gastrointestinal side effects such as diarrhea, which may affect quality of life and treatment tolerance. The gut microbiome, which is the collection of bacteria living in the digestive tract, may play a role in these symptoms. The purpose of this study is to examine how the gut microbiome changes during the early phase of abemaciclib treatment and how these changes relate to gastrointestinal symptoms experienced by patients. Participants will provide stool samples at multiple time points using mailed collection kits and will complete questionnaires about gastrointestinal symptoms while receiving standard-of-care abemaciclib therapy. All study procedures will be conducted remotely. Information gained from this study may help inform future supportive care strategies for breast cancer patients receiving abemaciclib.

Waitlist Available
Online Trial

University of Vermont

Image of Queen Elizabeth II Health Sciences Centre in Halifax, Canada.

Empowerment Program for Breast Cancer

18+
Female
Halifax, Canada

This study is evaluating a six-month, home-based Patient Empowerment Program (Breast Cancer PEP) for women receiving treatment for newly diagnosed invasive breast cancer. The program provides daily guidance on physical activity, arm and shoulder rehabilitation, stress-reduction practices, healthy lifestyle habits, and social support, all delivered through online videos, emails, and optional group sessions. The purpose of the study is to learn whether this program can reduce psychological distress and improve overall well-being compared with standard cancer care. Psychological distress will be measured using a simple questionnaire called the Kessler Psychological Distress Scale (K10). The study will also look at general health, quality of life, and participants' experiences with the program. A total of 160 women across Nova Scotia will take part. Participants will be randomly assigned to start the program right away or to receive standard care for six months before getting access to the program. Everyone will complete online questionnaires at the beginning of the study and again at 6 and 12 months. A small number of participants may also be invited to take part in optional interviews to share their experiences. Researchers will also explore how participants use the digital program, what parts are most helpful, and whether the program could be offered more broadly in the future. The trial is being conducted across all Nova Scotia Health zones and coordinated through the QEII Health Sciences Centre.

Waitlist Available
Has No Placebo

Queen Elizabeth II Health Sciences Centre

Image of UNC Cancer Hospital in Chapel Hill, United States.

Educational Brochure for Breast Cancer

18+
Female
Chapel Hill, NC

This study explores perspectives of women with non-metastatic breast cancer regarding their willingness and ability to make dietary changes pertaining to foods/food products that may pose a risk to their cancer prognosis and survival. This is a single-group study conducted entirely online. All study activities, including consent, educational brochure and surveys, will be completed remotely. Participants will receive email invitations to complete questionnaires in REDCap. Questionnaire 1 will collect sociodemographic information (no PHI) and a brief dietary recall. Questionnaire 2 will assess identification of ultra-processed foods. Before Questionnaire 3, participants will review a two-page educational flyer explaining the link between diet, obesity, and cancer, with information on unhealthy calories and food processing. Questionnaire 3 will assess participants' willingness and ability to eat healthier foods and reduce unhealthy foods. At study completion, participants will receive a thank-you message and a brief satisfaction survey.

Recruiting
Has No Placebo

UNC Cancer Hospital

Kirsten Nyrop, PhD

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Axelopran for Cancer

18+
All Sexes
Saint Louis Park, MN

The primary objective of this single arm, open label, phase II trial is to determine if axelopran use impacts cancer control in patients with advanced cancers of the lung, breast, pancreas, and prostate. The primary study period for assessing the primary aim is through day 43 (6 weeks). The main questions it aims to answer are: * Does axelopran show a signal for efficacy in slowing tumor progression? * Is axelopran safe and tolerable for long-term use in this patient population? * Does axelopran show a signal for efficacy in improving bowel function and quality of life? * Does axelopran show a signal for efficacy in reducing systemic inflammation, cachexia, and prognostic serum biomarkers of inflammation? Patients will take axelopran as monotherapy after relapse or progression on or after standard systemic therapy. Clinician and patient must be willing to attempt a delay in next line of systemic cancer therapy (if available) until day 43 to assess change in cancer status on repeat imaging. Clinician can move to the next line of therapy whenever deemed clinically necessary. Participants will: * take oral axelopran capsules daily for up to 1 year, or longer if deriving benefit * attend 10 in-person study visits, each lasting approximately 1-2 hours * complete study procedures including but not limited to imaging exams, blood draws, electronic health surveys, and physical assessments

Phase 2
Recruiting

HealthPartners Frauenshuh Cancer Research Center (+1 Sites)

Dylan Zylla, MD, MS

Glycyx MOR Inc.

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Epione Device for Bone Conditions

18+
All Sexes
San Diego, CA

The goal of this investigational device exemption is to evaluate the Epione assistance for introducer placement during percutaneous procedures in musculo-skeletic (MSK) structures of the pelvis and the spine in adults. The main question is the determination of the rate of feasible procedures assisted by the Epione device Participants will undergo their procedure(s) as planned by their physician. If they accept to participate to the study, the differences with standard of care will be: * The use of the Epione device to place the introducer(s), instead of freehand placement if they do not participate * Additional CT or CBCT scans during the procedure.

Recruiting
Has No Placebo

UC San Diego (+2 Sites)

Sean Tutton, MD

Precision IO Group

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Supplemental Imaging for Breast Cancer

25 - 55
Female
St Louis, MO

Recent research has shown that, among women with extremely dense breasts and normal results on mammogram, magnetic resonance imaging (MRI) use has significantly reduced the occurrence of breast cancer that is diagnosed during the time between two regular screening mammograms (also known as interval cancers). The investigators have developed and validated an approach to use the whole mammogram image, develop a mammogram risk score (MRS), and calibrate this to the SEER breast cancer incidence rates for US women. This model (Prognosia Breast) generates an absolute 5-year risk of breast cancer and classifies approximately 5.7% of the population as high risk using the ASCO 3% cut point as used for endocrine therapy to reduce risk. Follow-up generates an incidence of 25.2 cases per 1,000 women per year.

Recruiting
Has No Placebo

Washington University School of Medicine

Tabassum Ahmad, M.D.

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