Aloxi

Osteoporosis, Osteoporosis, Osteoporosis, Postmenopausal + 2 more

Treatment

6 FDA approvals

20 Active Studies for Aloxi

What is Aloxi

Raloxifene

The Generic name of this drug

Treatment Summary

Raloxifene is a prescription drug used to treat the symptoms of postmenopausal osteoporosis and reduce the risk of breast cancer in postmenopausal women. It works by blocking estrogen receptors in certain parts of the body, like the breast and uterus, while stimulating estrogen receptors in others, like the bones. It is available in many countries and was approved by the FDA in 1997. Common side effects include an increased risk of stroke and venous thromboembolism. Women who have a history of stroke, atrial fibrillation, or high blood pressure should speak to their doctor before taking raloxif

Evista

is the brand name

image of different drug pills on a surface

Aloxi Overview & Background

Brand Name

Generic Name

First FDA Approval

How many FDA approvals?

Evista

Raloxifene

1998

50

Approved as Treatment by the FDA

Raloxifene, otherwise known as Evista, is approved by the FDA for 6 uses which include Osteoporosis and Osteoporosis .

Osteoporosis

Osteoporosis

Postmenopausal Osteoporosis

Invasive Breast Cancer

Osteoporosis, Postmenopausal

Malignant Neoplasms

Effectiveness

How Aloxi Affects Patients

Raloxifene is a drug that helps to increase bone mineral density, reduce the risk of fractures, and decrease the risk of breast cancer in post-menopausal women. It works by blocking some of the effects of estrogen, which helps to reduce inflammation and improve bone strength. It also helps to lower levels of cholesterol and LDL cholesterol in the blood. However, it is not known if it will have the same cardioprotective effects as hormone replacement therapy.

How Aloxi works in the body

Raloxifene is a drug that affects the estrogen hormone in different ways in different parts of the body. It works by binding to estrogen receptors and causing a change in gene expression that can have an anti-inflammatory or anti-cancer effect. In bones, raloxifene acts like estrogen to promote bone growth and strength. In the breasts, raloxifene acts as an antagonist to estrogen to prevent cancerous cell growth and reduce inflammation.

When to interrupt dosage

The proposed measure of Aloxi is contingent upon the diagnosed condition, including Osteoporosis, Osteoporosis induced by glucocorticoid and Postmenopausal Osteoporosis. The dosage level is reliant upon the administration approach featured in the table beneath.

Condition

Dosage

Administration

Osteoporosis

60.0 mg,

, Tablet, Tablet - Oral, Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, coated, Tablet, coated - Oral

Osteoporosis

60.0 mg,

, Tablet, Tablet - Oral, Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, coated, Tablet, coated - Oral

Osteoporosis, Postmenopausal

60.0 mg,

, Tablet, Tablet - Oral, Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, coated, Tablet, coated - Oral

Breast

60.0 mg,

, Tablet, Tablet - Oral, Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, coated, Tablet, coated - Oral

Malignant Neoplasms

60.0 mg,

, Tablet, Tablet - Oral, Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, coated, Tablet, coated - Oral

Warnings

Aloxi has two contraindications and should not be employed when dealing with any of the circumstances in the following table.

Aloxi Contraindications

Condition

Risk Level

Notes

Pulmonary Embolism

Do Not Combine

potential for pregnancy

Do Not Combine

There are 20 known major drug interactions with Aloxi.

Common Aloxi Drug Interactions

Drug Name

Risk Level

Description

Abemaciclib

Major

The metabolism of Abemaciclib can be decreased when combined with Raloxifene.

Acalabrutinib

Major

The metabolism of Acalabrutinib can be decreased when combined with Raloxifene.

Alectinib

Major

The metabolism of Alectinib can be decreased when combined with Raloxifene.

Alpelisib

Major

The metabolism of Alpelisib can be decreased when combined with Raloxifene.

Aminophylline

Major

The metabolism of Aminophylline can be decreased when combined with Raloxifene.

Aloxi Toxicity & Overdose Risk

The toxic dose of raloxifene in rats is more than 810 times the amount of a human dose. No deaths have been reported from overdosing on raloxifene, but one non-fatal case exists when someone took 1.5 grams. Common side effects of taking too much raloxifene include leg cramps, hot flashes, and dizziness. In two 18-month-old children who accidentally took 180 mg of raloxifene, they experienced ataxia, dizziness, vomiting, rash, diarrhea, tremor, flushing, and elevated alkaline phosphatase levels

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

71 active trials are being conducted to investigate the utility of Aloxi in treating Postmenopausal Osteoporosis, Osteoporosis induced by glucocorticoid therapy and Breast Disorders.

Condition

Clinical Trials

Trial Phases

Osteoporosis

27 Actively Recruiting

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

Osteoporosis, Postmenopausal

0 Actively Recruiting

Osteoporosis

0 Actively Recruiting

Breast

3 Actively Recruiting

Not Applicable, Phase 1

Malignant Neoplasms

5 Actively Recruiting

Phase 2, Not Applicable

Aloxi Reviews: What are patients saying about Aloxi?

5

Patient Review

1/18/2009

Aloxi for Prevent Nausea and Vomiting from Cancer Chemotherapy

Decadron and Aloxi have been highly effective for me in preventing nausea and vomiting. I just finished my third treatment with this chemotherapy regimen, and so far the Aloxi has been great! I would definitely recommend it to others.

5

Patient Review

12/18/2007

Aloxi for Prevent Nausea and Vomiting from Cancer Chemotherapy

4.7

Patient Review

7/21/2018

Aloxi for Prevent Nausea and Vomiting from Cancer Chemotherapy

Aloxi was the only IV medication I received prior to my infusion of etoposide over three days. That was 10 days ago, and since then I haven't experienced any nausea or vomiting. The only reason I didn't give this five stars is because of the level of sedation it caused me. For round two, I'm going to get Aloxi infused on day one, then take etoposide pills at home on days 2 and 3.

4.7

Patient Review

1/8/2009

Aloxi for Prevent Nausea and Vomiting from Cancer Chemotherapy

4.3

Patient Review

4/9/2010

Aloxi for Nausea and Vomiting caused by Cancer Drugs

I've had no significant nausea from my chemotherapy, and I attribute this largely to the thorough combination of drugs given as premedication.

4

Patient Review

5/9/2012

Aloxi for Prevent Nausea and Vomiting from Cancer Chemotherapy

I had a slight headache the entire time I was on this medication, but it did help with my nausea and vomiting.

3.7

Patient Review

5/26/2012

Aloxi for Prevent Nausea and Vomiting from Cancer Chemotherapy

Six hours after receiving Aloxi injection, I experienced a horrible headache that was nearly migraine level. I have had a couple of migraines in my life but not a chronic problem. Had to use ice pack alternatively with heat to get relief and my pain pills did nothing (percoset) for relief. 48 hours after dosing, was given Fioriset to help control pain. Didn't have nausea from the chemo but did from the migraine. Dr. will try something different next infusion.

2.3

Patient Review

8/14/2014

Aloxi for Prevent Nausea and Vomiting from Cancer Chemotherapy

I was given Aloxi and Emend IV, and have been incredibly nauseous since. I was given Zofran for relief but was told not to take it because of the risk of QT prolongation. Honestly, I feel terrible right now.
image of drug pills surrounding a glass of water symbolizing drug consumption

Patient Q&A Section about aloxi

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

What type of medication is Aloxi?

"Aloxi is a medication used to prevent nausea and vomiting. It is effective against nausea and vomiting caused by surgery or cancer treatments such as chemotherapy or radiation."

Answered by AI

What is Aloxi given for?

"This medication is used to prevent nausea and vomiting caused by cancer drug treatment (chemotherapy). It is also used to prevent nausea and vomiting after surgery. Palonosetron works by inhibiting the action of serotonin, which is a natural substance that causes vomiting."

Answered by AI

Is Aloxi the same as Zofran?

"Ondansetron and palonosetron are anti-nausea medications. They are used to prevent nausea and vomiting caused by cancer chemotherapy. They are also used to prevent vomiting and nausea after surgery."

Answered by AI

How long is Aloxi effective?

"Palonosetron is a long-acting medication that prevents nausea and vomiting from chemotherapy. It is usually only necessary to take one dose, which lasts for 3 to 5 days."

Answered by AI

Clinical Trials for Aloxi

Image of UC San Diego in San Diego, United States.

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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Minoxidil for Breast Reconstruction

18+
Female
Durham, NC

The purpose of the study is to determine whether pharmacologic delay using minoxidil in patients undergoing bilateral risk reducing mastectomy with reconstruction could achieve improvement in flap perfusion and flap viability at the time of surgery. Patients will undergo randomization of their breasts to determine which breast will receive the experimental intervention and which breast will serve as the internal control (receive placebo). The experimental breast will receive the novel pharmacologic delay treatment, 5% minoxidil, while the internal control breast will receive the current standard of care, which does not include any topical application prior to surgery - a placebo control will be used. This will be a triple-blind study, where both the participants and investigators will be blinded to which breast will receive the intervention. The patients will receive two bottles "compound A" and "compound B" with directions from the pharmacy for which compound to apply to each breast. Product will be applied for 2 weeks prior to planned surgery. Surgery will proceed without any changes to standard practice.

Phase 1
Waitlist Available

Duke Health

Brett Phillips, MD

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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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Injury Prevention Care Models for Osteoporosis

65+
All Sexes
Boston, MA

The goal of this clinical trial is to compare three care models for optimizing medications and preventing falls with broken bones in patients receiving rehabilitation after a hospitalization for a broken bone. The primary outcome is injurious falls, with secondary outcomes measuring how the process of care is changed and capturing patient-reported outcomes valued by stakeholders. The main questions this study aims to answer are: * Which of the three models is more effective in preventing falls with fractures? * What are the differences in patient-centered outcomes amongst the three models? These include pain, depression, anxiety, sleep, medication side effect burden, and fear of falling. * What are the differences in osteoporosis treatment and medication burden? The three care models are: a Deprescribing Care Model designed to reduce or stop fall-related medications, a Bone Heath Service Model designed to provide osteoporosis evaluation and management, and an Injury Prevention Service Model offering both services. 42 SNFs will participate in this study. The three models will be incorporated into the routine care of patients at these facilities who are receiving rehabilitation after a hospitalization for a fracture. All care models will be delivered remotely to patients in the SNF and after they transition home by a post-fracture nurse consultant supported by an interprofessional team. This study has three aims. See Detailed Description for more details. This ClinicalTrials.gov record represents the Comparative Effectiveness Aim of the protocol.

Waitlist Available
Has No Placebo

Marcus Institute for Aging Research, Hebrew SeniorLife (+1 Sites)

Cathleen S Colon-Emeric, MD, MHS

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Milk + Yogurt for Bone Health

19 - 30
All Sexes
Saskatoon, Canada

Milk and dairy products contain significant amounts of nutrients that contribute to optimal health - nutrients like calcium, vitamin D, and high-quality protein. Fermented milk products or fermented dairy products are dairy foods that have been fermented with certain bacteria. Yogurt is a fermented dairy product containing millions of beneficial bacteria. In this study, the invesgitagtors will look at the effect of milk (a non-fermented dairy product) and yogurt (a fermented dairy product) supplementation on bone health and the amount of fat and muscle mass in Canadian young adults over a 24-month period. While dairy products contain significant amounts of nutrients, the scientific community does not know the impact of long-term supplementation of fermented (i.e., yogurt) or non-fermented (i.e., milk) dairy food on bone health and the amount of fat and muscle mass in young adults. To fill this knowledge gap, the investigators will recruit participants with low calcium intake and assign them to three different groups: 1) milk (intervention) group; 2) yogurt (intervention) group; and 3) control group. The investigators will ask the participants in the milk group to drink 1.5 servings (375 mL) of milk per day for 24 months. Participants in the yogurt group will consume 2 servings (350 g) of yogurt per day for 24 months. Those in the control group will continue their usual diets. Using a randomized controlled trial design, the investigators will measure bone health parameters, hormonal indices related to bone metabolism, body composition (e.g., muscle mass, fat mass), and the number and composition of bacteria living in the gastrointestinal (GI) tract. The hypothesis is that supplementation with yogurt will have more positive effects on bone health indices, particularly femoral neck BMD as the primary outcome, than milk in Canadian adults aged 19-30 years. The secondary hypothesis is that supplementation with yogurt, as a fermented milk product, will have a more beneficial effect than milk on body composition measures. The data will provide valuable information for developing targeted health initiatives and marketing strategies regarding the benefits of fermented and non-fermented dairy product consumption.

Recruiting
Has No Placebo

University of Saskatchewan

Hassan Vatanparast, MD, PhD

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