Endari

Osteoporosis, Anemia, Sickle Cell

Treatment

20 Active Studies for Endari

What is Endari

L-Glutamine

The Generic name of this drug

Treatment Summary

L-glutamine is an amino acid found throughout the body that is involved in many metabolic processes. It helps the body transport nitrogen and can be used as an energy source for cells. In 2017, an oral version of L-glutamine was approved by the FDA to treat sickle cell disease. It is sold under the brand name Endari by Emmaus Medical.

NutreStore

is the brand name

image of different drug pills on a surface

Endari Overview & Background

Brand Name

Generic Name

First FDA Approval

How many FDA approvals?

NutreStore

L-Glutamine

2008

2

Effectiveness

How Endari Affects Patients

Glutamine is an amino acid and an important part of protein. It plays an important role in how nitrogen is used by the body. The body converts glutamic acid into glutamine and uses it to make other molecules, such as other amino acids. L-glutamine can help balance the NAD redox potential, which is important for certain body processes.

How Endari works in the body

L-glutamine helps support the immune system in a number of ways. It helps protect the intestinal tract, and can prevent bacteria from travelling to other parts of the body. In addition, it helps maintain secretory IgA, which stops bacteria from attaching to cells in the body. It is necessary for the production of certain proteins that help fight infection, as well as for the growth and development of white blood cells. L-glutamine can also reduce oxidative damage to red blood cells, which can lead to fewer sickle cell crises and other complications.

When to interrupt dosage

The dosage of Endari depends on the identified illness. The extent of dosage shifts, as per the technique of delivery (e.g. Oral or Capsule) pointed out in the accompanying table.

Condition

Dosage

Administration

Osteoporosis

5000.0 mg, , 500.0 mg, 475.0 mg, 750.0 mg

, Powder, for solution, Oral, Powder, for solution - Oral, Tablet - Oral, Capsule - Oral, Capsule, Tablet

Anemia, Sickle Cell

5000.0 mg, , 500.0 mg, 475.0 mg, 750.0 mg

, Powder, for solution, Oral, Powder, for solution - Oral, Tablet - Oral, Capsule - Oral, Capsule, Tablet

Warnings

There are 1 known major drug interactions with Endari.

Common Endari Drug Interactions

Drug Name

Risk Level

Description

Lactulose

Moderate

The therapeutic efficacy of Lactulose can be decreased when used in combination with L-Glutamine.

Endari Toxicity & Overdose Risk

Generally, taking up to 21 grams of L-glutamine is safe, but can cause constipation and bloating. In one case, two people with hypomania experienced worsening of their manic symptoms after taking 2 to 4 grams of L-glutamine per day, but the symptoms ceased when they stopped taking the supplement. Common side effects reported in clinical trials of Endari include constipation (21%), nausea (19%), headache (18%), abdominal pain (17%), cough (16%), pain in the limbs (13%), back pain (12%), and chest pain (12%).

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

45 active studies are investigating the potential of Endari to address Anemia and Sickle Cell Disease.

Condition

Clinical Trials

Trial Phases

Anemia, Sickle Cell

0 Actively Recruiting

Osteoporosis

28 Actively Recruiting

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

Endari Reviews: What are patients saying about Endari?

1.7

Patient Review

1/31/2019

Endari for Sickle Cell Anemia

I didn't find this to be worth the price tag, and it didn't seem any more effective than if I had just taken a sugar pill.
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Patient Q&A Section about endari

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

What does Endari do for sickle cell?

"Endari works by increasing the amount of free glutamine in the blood. This can help sickle cells create more antioxidant molecules to neutralize oxidative stress."

Answered by AI

Is Endari FDA approved?

"Endari® is a medication that was approved by the FDA in July 2017 for the treatment of sickle cell disease in adult and pediatric patients five years of age and older. Sales of the medication began in 2018."

Answered by AI

What is Endari used for?

"ENDARI is a medication that is used to help reduce the acute complications that can occur in people with sickle cell disease. It is indicated for use in adults and children who are at least 5 years of age."

Answered by AI

Is Endari better than hydroxyurea?

"Endari reduces the number of pain crises and people who take it also have fewer and shorter hospital stays. The twice-daily powder form may be more challenging than the once-daily hydroxyurea tablets, but it is a non-chemotherapeutic option with minimal side effects."

Answered by AI

Clinical Trials for Endari

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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

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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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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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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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Teriparatide vs Alendronate for Osteoporosis

18+
Female
Lexington, KY

Osteoporosis is a health problem of major proportions. It affects more than 40 million Americans and results in more than 2 million fractures annually among Medicare patients alone. Hospital admissions for osteoporotic fractures exceed those of heart attacks, strokes and breast cancer combined. Osteoporosis is commonly considered a disease associated with menopause. This estrogen deficiency related bone loss is characterized by high bone turnover with increased resorption without commensurate changes in bone formation. It is in contrast to age-related bone loss, which starts as early as in the fourth decade of life and continues with increasing age. Age-related bone loss is usually associated with lower bone turnover and decreased bone formation is the main abnormality. Current therapies do not address age-related bone loss and the special needs of the age-related osteoporosis population is currently ignored. This is to a great degree due to difficulties associated with the bone biopsy necessary for unequivocal determination of bone turnover status. Thus, the current standard of care relies on starting with an antiresorber, which is of limited effectiveness in age-related osteoporosis, and in fact impedes the effectiveness of the appropriate anabolic medication. In a current ongoing study - Novel precision medicine approach to treatment of osteoporosis based on bone turnover. EIRB#70781; efforts are focused on addressing this particular problem. Our follow-up study seeks to achieve one specific aim: to compare effectiveness of Alendronate vs Teriparatide after participants have been switched at the end of treatment at year one, to the other drug at year two for the same duration of treatment.

Phase 4
Waitlist Available

University of Kentucky

Paul Netzel, DNP

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Donepezil for Alzheimer's Effects on Bone Metabolism

18+
All Sexes
Durham, NC

People with Alzheimer's disease are at an increased risk of bone fracture. Some studies have shown that those taking donepezil have a lower rate of bone fractures, but the reasons for this are unknown. The purpose of this study is to measure the effect of donepezil treatment on bone metabolism factors including bone mineral density, bone turnover markers, and bone quality. Participants in this study will have a bone density test and have blood samples collected at the baseline study visit. Participants will then be randomly assigned to donepezil or matching memantine to be taken daily by mouth for 12 months. Blood samples will be collected at 6 and 12 months. A repeat bone density test will be performed at 12 months. Participants will also complete questionnaires at each study visit.

Phase 2
Recruiting

Duke Memory Disorders Clinic

Richard H Lee, MD, MPH

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