Atelvia

Osteoporosis, Malignant Neoplasms, Postmenopause + 3 more

Treatment

5 FDA approvals

20 Active Studies for Atelvia

What is Atelvia

Risedronic acid

The Generic name of this drug

Treatment Summary

Risedronic acid is a medication used to prevent bone loss and the weakening of bones caused by conditions such as osteoporosis and Paget’s disease. It is a type of bisphosphonate, a form of drug that works by blocking the removal of bone cells.

Actonel

is the brand name

image of different drug pills on a surface

Atelvia Overview & Background

Brand Name

Generic Name

First FDA Approval

How many FDA approvals?

Actonel

Risedronic acid

1998

61

Approved as Treatment by the FDA

Risedronic acid, also called Actonel, is approved by the FDA for 5 uses including Therapeutic procedure and Paget’s Disease .

Therapeutic procedure

Paget’s Disease

Bone and Bones

Used to treat increased bone mass in combination with Calcium

Osteoporosis

Used to treat Osteoporosis in combination with Calcium

Postmenopause

Effectiveness

How Atelvia Affects Patients

Risedronate is a medicine that helps prevent bones from being broken down by blocking the activity of cells called osteoclasts.

How Atelvia works in the body

Risedronatic acid binds to the bones and stops cells that break down bones, called osteoclasts, from doing their job. It does this by entering the cells, becoming acidic, and then inhibiting an enzyme called farnesyl pyrophosphate synthase. This stops the osteoclast from breaking down the bones, which decreases bone resorption.

When to interrupt dosage

The proposed dose of Atelvia is contingent upon the recognized condition, including Therapeutic procedure, Malignant Neoplasms and Postmenopause. The measure fluctuates as per the technique of delivery, as detailed in the table beneath.

Condition

Dosage

Administration

Bone and Bones

30.0 mg, , 5.0 mg, 35.0 mg, 150.0 mg, 75.0 mg, 129.0 mg, 4.9 mg, 30.1 mg, 64.5 mg, 4.3 mg, 25.8 mg

, Oral, Tablet, film coated - Oral, Tablet, film coated, Tablet, Tablet - Oral, Granule, effervescent; Kit; Tablet, Granule, effervescent; Kit; Tablet - Oral, Tablet, delayed release, Tablet, delayed release - Oral, Tablet, Delayed Release - Oral, Tablet, Delayed Release, Kit; Tablet, Kit; Tablet - Oral, Kit

Osteoporosis

30.0 mg, , 5.0 mg, 35.0 mg, 150.0 mg, 75.0 mg, 129.0 mg, 4.9 mg, 30.1 mg, 64.5 mg, 4.3 mg, 25.8 mg

, Oral, Tablet, film coated - Oral, Tablet, film coated, Tablet, Tablet - Oral, Granule, effervescent; Kit; Tablet, Granule, effervescent; Kit; Tablet - Oral, Tablet, delayed release, Tablet, delayed release - Oral, Tablet, Delayed Release - Oral, Tablet, Delayed Release, Kit; Tablet, Kit; Tablet - Oral, Kit

Malignant Neoplasms

30.0 mg, , 5.0 mg, 35.0 mg, 150.0 mg, 75.0 mg, 129.0 mg, 4.9 mg, 30.1 mg, 64.5 mg, 4.3 mg, 25.8 mg

, Oral, Tablet, film coated - Oral, Tablet, film coated, Tablet, Tablet - Oral, Granule, effervescent; Kit; Tablet, Granule, effervescent; Kit; Tablet - Oral, Tablet, delayed release, Tablet, delayed release - Oral, Tablet, Delayed Release - Oral, Tablet, Delayed Release, Kit; Tablet, Kit; Tablet - Oral, Kit

Postmenopause

30.0 mg, , 5.0 mg, 35.0 mg, 150.0 mg, 75.0 mg, 129.0 mg, 4.9 mg, 30.1 mg, 64.5 mg, 4.3 mg, 25.8 mg

, Oral, Tablet, film coated - Oral, Tablet, film coated, Tablet, Tablet - Oral, Granule, effervescent; Kit; Tablet, Granule, effervescent; Kit; Tablet - Oral, Tablet, delayed release, Tablet, delayed release - Oral, Tablet, Delayed Release - Oral, Tablet, Delayed Release, Kit; Tablet, Kit; Tablet - Oral, Kit

Therapeutic procedure

30.0 mg, , 5.0 mg, 35.0 mg, 150.0 mg, 75.0 mg, 129.0 mg, 4.9 mg, 30.1 mg, 64.5 mg, 4.3 mg, 25.8 mg

, Oral, Tablet, film coated - Oral, Tablet, film coated, Tablet, Tablet - Oral, Granule, effervescent; Kit; Tablet, Granule, effervescent; Kit; Tablet - Oral, Tablet, delayed release, Tablet, delayed release - Oral, Tablet, Delayed Release - Oral, Tablet, Delayed Release, Kit; Tablet, Kit; Tablet - Oral, Kit

Paget’s Disease

30.0 mg, , 5.0 mg, 35.0 mg, 150.0 mg, 75.0 mg, 129.0 mg, 4.9 mg, 30.1 mg, 64.5 mg, 4.3 mg, 25.8 mg

, Oral, Tablet, film coated - Oral, Tablet, film coated, Tablet, Tablet - Oral, Granule, effervescent; Kit; Tablet, Granule, effervescent; Kit; Tablet - Oral, Tablet, delayed release, Tablet, delayed release - Oral, Tablet, Delayed Release - Oral, Tablet, Delayed Release, Kit; Tablet, Kit; Tablet - Oral, Kit

Warnings

Atelvia has three contraindications, so it ought not be administered when encountering any of the circumstances outlined in the following table.

Atelvia Contraindications

Condition

Risk Level

Notes

Severe Hypersensitivity Reactions

Do Not Combine

Risedronic Acid may interact with Pulse Frequency

Hypocalcemia

Do Not Combine

Postural Orthostatic Tachycardia Syndrome

Do Not Combine

There are 20 known major drug interactions with Atelvia.

Common Atelvia Drug Interactions

Drug Name

Risk Level

Description

Etidronic acid

Minor

The risk or severity of adverse effects can be increased when Risedronic acid is combined with Etidronic acid.

Incadronic acid

Minor

The risk or severity of adverse effects can be increased when Risedronic acid is combined with Incadronic acid.

Tiludronic acid

Minor

The risk or severity of adverse effects can be increased when Risedronic acid is combined with Tiludronic acid.

Acipimox

Moderate

The risk or severity of myopathy, rhabdomyolysis, and myoglobinuria can be increased when Risedronic acid is combined with Acipimox.

Aluminium clofibrate

Moderate

The risk or severity of myopathy, rhabdomyolysis, and myoglobinuria can be increased when Risedronic acid is combined with Aluminium clofibrate.

Atelvia Toxicity & Overdose Risk

Ten percent of people taking this drug have reported experiencing back pain, joint pain, stomach pain, and indigestion. Other rare side effects include swelling of the face, skin rashes, eye irritation, and inflammation of the uvea. If someone takes too much of this drug, they may have reduced levels of calcium and phosphorus in their blood. Treatment options include drinking milk or taking antacids to bind the drug and reduce absorption. In more serious cases, a doctor may need to give the patient their stomach contents or intravenous calcium. A single overdose of this drug in rats was found to be 320 to 620 times the

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

Fifty active trials are being conducted to assess the potential of Atelvia to treat Paget's Disease, Postmenopause and Malignant Neoplasms.

Condition

Clinical Trials

Trial Phases

Postmenopause

4 Actively Recruiting

Phase 2, Not Applicable

Therapeutic procedure

0 Actively Recruiting

Paget’s Disease

0 Actively Recruiting

Bone and Bones

0 Actively Recruiting

Malignant Neoplasms

0 Actively Recruiting

Osteoporosis

28 Actively Recruiting

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

Atelvia Reviews: What are patients saying about Atelvia?

5

Patient Review

11/10/2014

Atelvia for Decreased Bone Mass Following Menopause

I've been taking Atelvia for over a year and it's shown significant improvements in my condition with no negative side effects that I've experienced. My doctor is happy to keep me on the medication as long as they deem it safe, and I'm very content with the results.

5

Patient Review

3/27/2015

Atelvia for Osteoporosis

This medication has been incredibly effective for me. I used to have to give myself a shot every day for two years with no improvement, but this drug has really helped.

4.7

Patient Review

10/8/2014

Atelvia for Osteoporosis

I found this much easier to take than Actonel, and I've been taking it for years without any side effects. In most areas, it seems to have kept osteopenia at bay; however, in some areas it has progressed to osteoporosis. Overall, though, it did not improve my condition but prevented it from getting worse in most places.

4

Patient Review

9/22/2014

Atelvia for Osteoporosis

I took Forteo to build up my bones and Atelvia to secure the gain (15%). It has been very effective over 3 years. I am 84 years old.

3

Patient Review

12/6/2013

Atelvia for Decreased Bone Mass Following Menopause

I was experiencing pain in my joints.

2.3

Patient Review

11/18/2014

Atelvia for Osteoporosis

The stomach cramps, diarrhea and joint pain were really unpleasant. I gave it three doses before giving up.

2

Patient Review

10/3/2015

Atelvia for Osteoporosis

I took Atelvia for 5 weeks and felt awful for the first three. I developed jaw pain in weeks four and five and had to get x-rays done by a dentist. They told me this medication was bad news and advised me to stop taking it immediately. I'm now on the hunt for more natural methods that don't come with such intense side effects.

2

Patient Review

5/15/2015

Atelvia for Osteoporosis

This treatment unfortunately made my stomach upset and gave me indigestion, on top of making me feel generally ill like I had the flu.

1.7

Patient Review

10/25/2013

Atelvia for Osteoporosis

I took a sample of this pill less than 24 hours ago and I already feel awful. I've got severe aches and pains, a nasty headache, and nausea. If you're considering this medication, I would not recommend it.

1.7

Patient Review

7/8/2014

Atelvia for Osteoporosis

I unfortunately had to stop taking this medication after four weeks due to the severe stomach pain I was experiencing. It's been a real bummer because it seemed to be working well otherwise. If anyone knows of any other treatments for osteoporosis, please let me know.

1.7

Patient Review

7/14/2014

Atelvia for Post-Menopausal Osteoporosis Prevention

This medication made me sick in so many ways. Constant diarrhea, headaches, flu symptoms, inflammation, etc. In my opinion, this drug should be taken off the market.

1.7

Patient Review

2/22/2014

Atelvia for Osteoporosis

I've only taken one dose of this. It has been 4 days... had a headache the first day . Started getting Very noticeable pain in my femur bone, yesterday and today my ribs are aching. I've been using icepacks on both. I'm afraid to continue this medication... going to call the Dr. on Monday to consult with him.

1.7

Patient Review

4/14/2014

Atelvia for Osteoporosis

I had awful intestinal cramps that lasted for weeks, and the diarrhea was incredibly unpleasant. I needed a medication to stop the muscle spasms. Thankfully, I will never have to take this again.

1.3

Patient Review

2/25/2014

Atelvia for Decreased Bone Mass Following Menopause

I really dislike the side effects of this drug. They include muscle tightness, leg and arm pain, common cold problems, esophagus problems, jaw bone and thigh bone fractures, among others.

1.3

Patient Review

5/6/2014

Atelvia for Decreased Bone Mass Following Menopause

This medicine made me very ill each time I took it. The first day would be fine, but by the second day I would become severely ill with abdominal pain, aches all over my body, diarrhea, low grade fever, and an extreme headache. These symptoms would persist for two to three days before gradually improving; however, even after taking the medication I would still experience abdominal pain whenever I ate anything.

1

Patient Review

1/30/2014

Atelvia for Decreased Bone Mass Following Menopause

I was really sick after taking this pill, and it's been a few days and I'm still not feeling great. I would never recommend this medication to anyone.

1

Patient Review

5/31/2017

Atelvia for Decreased Bone Mass Following Menopause

The first dose of this medication resulted in weeks of abdominal pain and diarrhea. I was unable to take the second dose as prescribed. This is not an effective treatment for me

1

Patient Review

5/6/2014

Atelvia for Osteoporosis

For the last three days, I've been dealing with debilitating muscle pain.
image of drug pills surrounding a glass of water symbolizing drug consumption

Patient Q&A Section about atelvia

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

What are the side effects of Atelvia?

"The individual may experience stomach pain or discomfort, nausea, vomiting, flu-like symptoms, back pain, muscle pain, diarrhea, or constipation."

Answered by AI

How often do you take Atelvia?

"Atelvia may be used to treat osteoporosis in postmenopausal women. It is a delayed-release tablet that is taken once a week."

Answered by AI

What is Atelvia used for?

"Atelvia is a prescription medication used to treat osteoporosis in postmenopausal women. The longevity of Atelvia's efficacy is unknown. You should consult your physician periodically to see if Atelvia is still an appropriate medication for you."

Answered by AI

How long can you take Atelvia?

"Do as your doctor says when taking Atelvia. This includes following directions on the prescription label and reading all medication guides or instruction sheets. Your doctor may sometimes change your dose of the medication. Risedronate is commonly only taken for 3 to 5 years."

Answered by AI

Clinical Trials for Atelvia

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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Image of Don tyson Center for Agricultural Sciencers in Fayetteville, United States.

Protein and Exercise for Postmenopausal Women

Any Age
Female
Fayetteville, AR

The goal of this clinical trial is to learn if consuming a higher protein diet that includes one serving of beef each day, in combination with resistance exercise, improves wellbeing in postmenopausal women. It will also tell us about how higher protein intake changes body composition and blood values related to health. The main questions it aims to answer are: * Does higher protein intake combined with resistance training improve mood and sleep in postmenopausal women? * What other health benefits to postmenopausal women experience when the follow a higher protein diet and participate in resistance exercise? Researchers will compare three groups 1) postmenopausal women living their daily lives as usual, 2) postmenopausal women consuming a higher protein diet, and 2) postmenopausal women consuming a higher protein diet and participating in resistance training. Participants will: * Consume a higher protein diet for 16 weeks * Participate in an at-home resistance training for 16 weeks * Keep a diary of their food intake, sleep habits, and mood * Have health assessments every 4 weeks

Recruiting
Has No Placebo

Don tyson Center for Agricultural Sciencers (+1 Sites)

Jamie Baum

Image of The Buck Institute for Research on Aging in Novato, United States.

GLYLO Supplement for Postmenopausal Aging

45 - 65
Female
Novato, CA

The aim of this study is to assess the effectiveness of GLYLO, a dietary supplement, in postmenopausal women aged 45 to 65 who are overweight or obese and have elevated HbA1c levels. Specifically, the study seeks to evaluate whether GLYLO can reduce advanced glycation end products (AGEs) levels, which are harmful compounds formed when sugar attaches to proteins or fats in the body and can contribute to aging and disease. The primary outcome of the study is to determine if GLYLO reduces AGEs, enhances metabolic and hormonal health, and mitigates age-related functional decline. This study includes one screening visit and three testing visits over a 6-month period. After eligibility is confirmed, participants will be randomly assigned to one of two groups to take either GLYLO (two capsules daily) or a placebo at home for 24 weeks. Participants will provide blood samples at every visit. During the three testing visits, they will complete physical performance and cognitive function tests, provide both blood and urine samples, and fill out quality of life and 24-hour dietary intake questionnaires. The dietary intake questionnaires will be completed only twice i.e. at the baseline visit and again at the final 6-month visit.

Recruiting
Advanced

The Buck Institute for Research on Aging

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

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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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We made a collection of clinical trials featuring Atelvia, we think they might fit your search criteria.
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