Endari

Osteoporosis, Anemia, Sickle Cell
Treatment
20 Active Studies for Endari

What is Endari

L-GlutamineThe Generic name of this drug
Treatment SummaryL-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.
NutreStoreis 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 PatientsGlutamine 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 bodyL-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, Powder, for solution - Oral, Oral, Tablet, Tablet - Oral, Capsule - Oral, Capsule
Anemia, Sickle Cell
5000.0 mg, , 500.0 mg, 475.0 mg, 750.0 mg
, Powder, for solution, Powder, for solution - Oral, Oral, Tablet, Tablet - Oral, Capsule - Oral, Capsule

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 RiskGenerally, 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
27 Actively Recruiting
Not Applicable, Phase 4, Phase 1, Phase 3, Phase 2

Endari Reviews: What are patients saying about Endari?

1.7Patient 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

Image of University of Maryland, Baltimore, Department of Epidemiology and Public Health, Division of Gerontology in Baltimore, United States.

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
Image of Arthritis Research Canada in Vancouver, Canada.

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
Have you considered Endari clinical trials? We made a collection of clinical trials featuring Endari, we think they might fit your search criteria.Go to Trials
Image of Marcus Institute for Aging Research, Hebrew SeniorLife in Boston, United States.

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
Image of University of Saskatchewan in Saskatoon, Canada.

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 SaskatchewanPhil Chilibeck, PhD
Have you considered Endari clinical trials? We made a collection of clinical trials featuring Endari, we think they might fit your search criteria.Go to Trials
Image of Duke Memory Disorders Clinic in Durham, United States.

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 ClinicRichard H Lee, MD, MPH
Have you considered Endari clinical trials? We made a collection of clinical trials featuring Endari, we think they might fit your search criteria.Go to Trials
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