Ibandronate Sodium

Osteoporosis, Malignant Neoplasms, Bone Metastases + 1 more

Treatment

2 FDA approvals

20 Active Studies for Ibandronate Sodium

What is Ibandronate Sodium

Ibandronate

The Generic name of this drug

Treatment Summary

Ibandronate (also known as BM 21.0955) is a type of drug commonly used to help prevent and treat osteoporosis in postmenopausal women. It was first developed in 1993 as a treatment for bone loss in dogs and was approved by the FDA in 2003. Ibandronate is a third-generation bisphosphonate, which is similar to other drugs such as zoledronic acid, minodronic acid, and risedronic acid.

Boniva

is the brand name

image of different drug pills on a surface

Ibandronate Sodium 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 Ibandronate Sodium Affects Patients

Ibandronate is a drug used to both treat and prevent weak bones in postmenopausal women. It is generally considered safe, with effects lasting up to 157 hours. However, it can have some side effects, including upper gastrointestinal problems, low calcium levels, muscle pain, jawbone death, unusual fractures of the thigh bone, and serious issues with the kidneys.

How Ibandronate Sodium works in the body

Bisphosphonates are taken into the bone and bind to hydroxyapatite. This helps to stop osteoclasts from breaking down the bone. Ibandronate, a nitrogen-based bisphosphonate, stops tumor cells from reproducing by blocking certain molecules from the mevalonate pathway. This stops GTP-binding proteins like Rap1 from functioning, resulting in cell death. Ibandronate also activates caspase-3, which also contributes to cell death.

When to interrupt dosage

The proposed measure of Ibandronate Sodium is contingent upon the determined circumstance, for example Bone Metastases, Malignant Neoplasms and Osteoporosis. Dosage additionally depends on the mode of delivery, as demonstrated 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, film coated, Tablet, film coated - Oral, Oral, Liquid, Injection, solution, concentrate - Intravenous, Injection, solution, concentrate, Injection, Injection - Intravenous, Liquid - Intravenous, Tablet, Tablet - Oral

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

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

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

Warnings

Ibandronate Sodium 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 Ibandronate Sodium.

Common Ibandronate Sodium 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.

Ibandronate Sodium Toxicity & Overdose Risk

Those who take too much ibandronate may experience low calcium or phosphate levels, upset stomach, heartburn, esophagitis, and ulcers. To reduce absorption, patients can be given milk or antacids. Intravenous electrolytes may also be administered to help manage the overdose and dialysis is not expected to help remove the drug from the blood.

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Ibandronate Sodium Novel Uses: Which Conditions Have a Clinical Trial Featuring Ibandronate Sodium?

729 active trials are currently underway to assess the potential of Ibandronate Sodium to manage Bone Metastases, Malignant Neoplasms and Osteoporosis.

Condition

Clinical Trials

Trial Phases

Osteoporosis

28 Actively Recruiting

Not Applicable, Phase 4, Phase 1, Phase 3, Phase 2

Breast Cancer

19 Actively Recruiting

Phase 2, Phase 1, Not Applicable

Bone Metastases

6 Actively Recruiting

Phase 4, Not Applicable, Phase 3

Malignant Neoplasms

0 Actively Recruiting

Ibandronate Sodium Reviews: What are patients saying about Ibandronate Sodium?

3

Patient Review

10/3/2015

Ibandronate Sodium for Decreased Bone Mass Following Menopause

I'm waiting for a test to see the efficacy of this treatment, which won't be until next year.

2.3

Patient Review

5/2/2013

Ibandronate Sodium for Decreased Bone Mass Following Menopause

I unfortunately experience a red rash as a side effect of this medication. It's most visible behind my knees and inner thighs, but I have also noticed it on my calves and outer thighs. The rash doesn't itch, but it is very unsightly. Usually the rash goes away after a few days; however, I am considering discontinuing the medication because of this issue.

2

Patient Review

5/3/2017

Ibandronate Sodium for Post-Menopausal Osteoporosis Prevention

I had pain in my hip, thigh, and shoulder 2-3 days after taking the pill. I also felt really tired and achy. The second month I had the same side effects plus indigestion. I hope I don't have to keep dealing with this every month.

1.7

Patient Review

7/11/2016

Ibandronate Sodium for Post-Menopausal Osteoporosis Prevention

I had such intense and debilitating side effects from this treatment that I would rather take my chances with bone loss than use it again.

1

Patient Review

7/5/2016

Ibandronate Sodium for Decreased Bone Mass Following Menopause

I started taking this medicine on 7/2/16 and immediately began feeling flu-like symptoms. My arms and legs felt heavy and rubbery, and I was exhausted all the time. I was previously taking Fosamax, which had left me crippled, so I thought I would try this new medication. Unfortunately, it seems to be just as bad, if not worse.
image of drug pills surrounding a glass of water symbolizing drug consumption

Patient Q&A Section about ibandronate sodium

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

What is the drug ibandronate sodium used for?

"Ibandronate is a medication used to treat and prevent osteoporosis in postmenopausal women. A prescription is required in order to obtain this medication."

Answered by AI

What are the side effects of ibandronate sodium?

"The symptoms of this illness include nausea, stomach pain, diarrhea, constipation, weakness, dizziness, headache, fever, sore throat, chills, cough, and other signs of infection."

Answered by AI

When should you take ibandronate sodium?

"Adults should take 2.5mg once a day in the morning, or 150mg once a month on the same date, at least 60 minutes before the first food or drink of the day (apart from water). Children's doses must be determined by a doctor."

Answered by AI

How long should you take ibandronate sodium?

"After taking bisphosphonates for at least 3 to 5 years, your doctor will consider your risk factors in determining whether you should continue to take these or other osteoporosis medications."

Answered by AI

Clinical Trials for Ibandronate Sodium

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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.

Waitlist Available
Has No Placebo

UC San Diego (+2 Sites)

Sean Tutton, MD

Quantum Surgical

Image of University of Waterloo in Waterloo, Canada.

Virtual Chiropractic Intervention for Spinal Fracture

18+
All Sexes
Waterloo, Canada

This study will determine feasibility of a chiropractor delivered virtual intervention for individuals following osteoporotic vertebral fracture. This pilot trial will have two parallel groups with a 1:1 ratio. Participants will be randomized to: 1) immediate receipt; or 2) waitlist usual care control and delayed receipt of VIVA 10 weeks post-randomization. VIVA is an intervention for people with vertebral fractures that covers four areas: pain management, safe movement, exercise, and nutrition. It includes print and video resources, and a framework for goal setting, selecting exercises, and teaching body mechanics. A chiropractor (DC) completes a virtual assessment and then leads twelve 1:1 virtual sessions (via Zoom) over eight weeks. Sessions start with brief education on a topic (e.g., safe movement, pain management, exercise, nutrition), followed by training and modeling of exercise and safe movement strategies, then goal setting, and action planning. This trial will be considered feasible if a) we recruit 14 people in eight months; b) 80% of participants complete the trial; and c) exercise adherence is 75%.

Recruiting
Has No Placebo

University of Waterloo

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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.

Waitlist Available
Has No Placebo

Washington University School of Medicine

Tabassum Ahmad, M.D.

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Algorithm-Based Treatment Options for Advanced Breast Cancer

18 - 120
All Sexes
Bethesda, MD

Background: Breast cancer is the most common cancer in US women. There are different types of breast cancers; some are aggressive and difficult to treat. Researchers want to know if an algorithm (ENLIGHT) can help choose approved drugs that will treat these cancers more effectively. Objective: To test whether ENLIGHT can find better treatments for aggressive breast cancers. Eligibility: People aged 18 years and older with triple-negative or endocrine therapy resistant breast cancer; the cancer must have either failed to respond to treatment or come back after treatment. Design: Participants will be screened. A sample of tissue taken from the tumor will be tested using ENLIGHT as well as another method (TruSight Oncology 500). Participants will be assigned to 1 of 3 groups based on the algorithm search results: Group 1: No drug option was recommended. Participants will continue with their standard treatment with their local doctors. Group 2: A drug already approved for the participant's disease was recommended, but the participant has not yet received it. These results will be sent to the participant's local doctors. Participants may return to the NIH if their disease gets worse after using the suggested drugs. Group 3: A drug approved for other uses was recommended. Participants will be treated with the recommended drugs at the NIH; their care will be managed by an NIH doctor. They will continue to receive treatment as long as the drugs are helping them. They will have follow-up visits for 2 years after treatment ends. Participants who are not treated at the NIH will be contacted for a check on their health every 3 months for 2 years.

Recruiting
Has No Placebo

National Institutes of Health Clinical Center

Padma S Rajagopal, M.D.

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ChatGPT Education for Breast Reconstruction in Breast Cancer

18+
All Sexes
Saint Louis, MO

In this study, patients who are scheduled for breast reconstruction consultation will be randomized into the intervention group (ChatGPT-generated patient education regarding possible reconstruction options) or the control group (usual patient education). All patients will complete a survey following their in-person consultation to assess their experience and overall satisfaction with the consultation process. Additionally, participating surgeons will complete a separate survey to evaluate their consultation experience, satisfaction, and to assess the accuracy and clinical utility of the ChatGPT-generated patient education materials. The surveys are designed to gather information on patient characteristics, organizational health literacy according to Brega et al. Other survey questions have been designed to meet the outcomes of this study and have not been based on previously published surveys.

Recruiting
Has No Placebo

Washington University School of Medicine (+1 Sites)

Saif M Badran, M.D., Ph.D., FRCS

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Exercise Programs for Cancer

18+
All Sexes
Calgary, Canada

EXCEL will provide online and, where feasible, in-person exercise programs to individuals living with and beyond cancer (ILWBC). Research has shown that targeted programs that include tailored exercise prescriptions are more successful in helping individuals with chronic disease to incorporate physical activity and exercise into their daily routines. While ILWBC are advised by healthcare professionals (HCPs) to engage in exercise, there is a lack of cancer-specific exercise programs and cancer-trained exercise specialists in Canada, outside of the research setting. Considering the negative impact cancer and its treatments have on fitness and physical activity levels, community-based efforts towards improving access, uptake and maintenance of exercise programming are needed. This study will evaluate the benefits of a community-based or online EXCEL exercise program for people living with and beyond cancer across Canada, using a streamlined intake process compared to the original EXCEL Study (HREBA.CC-20-0098, NCT04478851). This 8 to 12-week program (intervention) will be delivered in-person or over virtual platform. It includes twice weekly supervised exercise classes.

Recruiting
Has No Placebo

University of Calgary (+4 Sites)

Nicole Culos-Reed, PhD

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OPTIONS Program for Osteoporosis

65+
All Sexes
Baltimore, MD

Osteoporosis is a disease that weakens bones so the bones may break easily. The risk for osteoporosis increases with age in both women and men. Osteoporosis affects 10 million older adults in the US. Osteoporosis is a common cause of broken bones in the hips and legs. Broken bones can lead to disability, nursing home placement, and death. Because of the dire consequences, a broken hip or leg is one of the most dreaded injuries for older adults. Many studies confirm that a simple regimen of exercise, healthy diet and bone-strengthening medications can improve overall recovery after a broken hip or leg. This regimen can prevent a person from becoming disabled, having future fractures, and even prevent death. Many older adults have surgery in a hospital after breaking a hip or leg. Then older adults go to a skilled nursing facility (SNF) for rehabilitation. Care in SNFs varies greatly. Some patients do not receive the regimen that the investigators know is most beneficial to improve bone health and recovery. Even patients who get exercise, healthy diet, and bone-strengthening medication in the SNF, may not continue with the regimen once patients go home. Therefore, the investigators want to implement and test OsteoPorotic fracTure preventION System (OPTIONS). OPTIONS is a program that will integrate the regimen into the care that is provided in SNFs and after discharge to the community. OPTONS will provide information about exercise, diet, and bone-strengthening medication. OPTIONS will provide doctors, clinical staff, patients, and care partners with the information these stakeholders need to carry out the best-practice regimen. The investigators are partnering with PointClickCare, a large cloud-based healthcare software provider, with SNFs and community care sites across the US. The investigators will include 32 SNFs from different US areas. The investigators will flip a coin to assign SNFs to the intervention (OPTIONS) or the control arm (enhanced usual care) of the study. Enhanced usual care is the care that is typically provided in SNFs after a fracture and adding information about a publicly available fall prevention toolkit. The investigators are using an "implementation science" approach that requires the investigators to get input from the OPTIONS study's vast stakeholder community throughout the study. The OPTIONS study's stakeholders include patients, care partners, clinicians, and professional organizations. The research question is, can using OPTIONS in SNFs and in the community after discharge improve physical function and quality of life in older people in the year after a hip or leg fracture? The investigators are measuring patient-reported outcomes. The investigators will include 1553 patients across the 32 facilities. The investigators have selected outcomes that are important to patients. Specifically, the investigators are measuring patient-reported function and quality of life. The investigators are also measuring patient-reported falls and fractures. The investigators will track the number of patients who die during the study. This study's hypothesis is that patients who receive OPTIONS will report better physical function (i.e., can walk and take better care of themselves) than those who receive enhanced usual care. The investigators also hypothesize that patients that receive OPTIONS will report a better quality of life than those who receive enhanced usual care. This study will provide sound data about the effectiveness of OPTIONS. OPTIONS could then be spread to other SNFs and community-based programs. This would ensure that all older people receive the right care after a hip or leg fracture.

Waitlist Available
Has No Placebo

University of Maryland, Baltimore, Department of Epidemiology and Public Health, Division of Gerontology (+1 Sites)

Denise Orwig, PhD

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Virtual Rehabilitation for Spinal Fracture

18+
All Sexes
Vancouver, Canada

Spine fractures are the most common fracture due to osteoporosis. They happen during falls or activities of daily life, like bending to tie shoes. Fractures of the spine can result in pain, which can sometimes last for a long time. Spine fractures can affect breathing, appetite, digestion, and mobility, and can restrict or modify people's work or daily activities. There are no standard rehabilitation programs after spine fracture, and patients often have to pay for rehabilitation. Rehabilitation can be hard to access, especially in rural or remote locations. It can be hard to find health care or rehabilitation providers who specialize in treating spine fractures. After reviewing research and consulting patients and health care providers to understand their experiences with spine fracture rehabilitation, the research team developed a toolkit for a virtual rehabilitation program for people with spine fractures, called VIVA. The research team wants to submit a grant for a clinical trial to implement VIVA in five provinces and determine if VIVA reduces pain and improves physical functioning and quality of life, and if the benefits outweigh the costs. Before this, the team proposes to do a pilot study to test how feasible it is to do a study of VIVA in three provinces.

Waitlist Available
Has No Placebo

Arthritis Research Canada (+5 Sites)

Lora Giangregorio, PhD

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