Actonel

Osteoporosis, Malignant Neoplasms, Postmenopause + 3 more

Treatment

5 FDA approvals

20 Active Studies for Actonel

What is Actonel

Risedronic acid

The Generic name of this drug

Treatment Summary

Risedronic acid is a medication used to treat certain forms of osteoperosis and Paget's disease. It works by preventing the breakdown of bones and helps to keep bones strong. It is a type of third generation bisphosphonate and has been approved by the FDA for use in these conditions.

Actonel

is the brand name

image of different drug pills on a surface

Actonel 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 Actonel Affects Patients

Risedronate is a medication that works to stop bones from being broken down in the body. It does this by blocking the activity of cells involved in the breakdown process (called osteoclasts).

How Actonel works in the body

Risedronate acid works by binding to the bones in the body. When bones are broken down, this acid is released and taken into osteoclasts, which are cells that break down bones. The acid stops the osteoclasts from working, meaning that bones are not broken down any further. This helps to reduce bone resorption and maintain healthy bones.

When to interrupt dosage

The proposed dose of Actonel is contingent upon the ascertained condition, including Therapeutic procedure, Malignant Neoplasms and Postmenopause. The quantity of dosage differs, as indicated by the method of delivery outlined 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

Actonel 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 Actonel.

Common Actonel 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.

Actonel Toxicity & Overdose Risk

Up to 10% of people taking this drug may experience back pain, joint pain, stomach pain, or indigestion. Less commonly, patients may develop a rash, swelling, eye irritation, or inflammation of the eyes. In cases of overdose, calcium and phosphorus levels in the blood may drop. To reduce the drug's absorption, milk or antacid tablets may be given. In more serious cases, a stomach-washing procedure and calcium given through an IV may be required. In rats, it takes up to 620 times the normal human dose to be fatal.

image of a doctor in a lab doing drug, clinical research

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

50 active clinical trials are presently being conducted to assess the potential of Actonel in addressing 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

Actonel Reviews: What are patients saying about Actonel?

5

Patient Review

8/24/2017

Actonel for Osteoporosis

I've been taking Actonel for three years now to treat my osteoporosis and it's been really effective.

5

Patient Review

3/24/2017

Actonel for Osteoporosis

I'm glad I found this treatment. It's really effective for me and I would recommend it to others.

4.7

Patient Review

5/29/2021

Actonel for Post-Menopausal Osteoporosis Prevention

So far, so good! I took my first dose this morning and have had no side effects whatsoever. I'm hopeful that this will help with my bone density issue.

4

Patient Review

7/14/2021

Actonel for Decreased Bone Mass Following Menopause

I've been taking Actonel for two decades now and it has definitely helped control my bone density loss. I'm 80 years old and still going strong!

3

Patient Review

9/24/2018

Actonel for Osteoporosis

I started taking Actonel for my osteoporosis per my doctor's orders. However, I woke up feeling awful the next day. Aches, fever, stomach issues; I felt like crap. Additionally, I read about some pretty scary potential side effects (jaw problems) and am now second-guessing whether or not to continue with the medication.

2

Patient Review

7/11/2014

Actonel for Decreased Bone Mass Following Menopause

I didn't have a great experience with this medication. I developed flu-like symptoms including headaches, body aches, and mental fog every time I took it. Additionally, I experienced severe stomach cramps that actually caused me to miss work on multiple occasions.

1

Patient Review

10/21/2018

Actonel for Decreased Bone Mass Following Menopause

I took the first pill of this monthly medication and immediately got sick. I felt dizzy, had stomach pains and heartburn, and terrible headaches. I missed work and went to the ER, where they told me that the effects of the medication just had to wear off. I will never take that pill again - it's not worth it.

1

Patient Review

1/16/2022

Actonel for Osteoporosis

I HIGHLY recommend avoiding this medication. I had incredibly unpleasant side effects that made me wish for death. This is not an exaggeration. The FDA should be sued for approving it.

1

Patient Review

10/18/2015

Actonel for Post-Menopausal Osteoporosis Prevention

The pain this medication caused was unbearable. I was out of work for three days and had a horrible headache the entire time. I don't understand how the FDA approved this medicine. It's going to kill me before my osteoporosis does.

1

Patient Review

11/9/2013

Actonel for Decreased Bone Mass Following Menopause

I just started taking this medication and would like to learn more about it.
image of drug pills surrounding a glass of water symbolizing drug consumption

Patient Q&A Section about actonel

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

How long should you take Actonel for osteoporosis?

"To reduce the risk of rare thighbone fractures, your doctor may recommend that you take a bisphosphonate holiday, or temporary break, after 3 to 5 years. People with severe osteoporosis may need to wait up to 10 years before stopping bisphosphonate drugs."

Answered by AI

Which is better Actonel or Fosamax?

"In clinical trials, Actonel was shown to work faster than Fosamax, and this new study suggests that the trend continues. The study found that at both six and 12 months, patients given Actonel had a significantly lower rate of fracture at hip and non-vertebral sites."

Answered by AI

Does Actonel improve bone density?

"Actonel is used in the prevention and treatment of osteoporosis. It reduces the rate at which bone cells are absorbed, which in turn allows the body to increase bone density and reduce the risk of fracture."

Answered by AI

What are the possible side effects of Actonel?

"You may have an upset stomach, stomach pain, headache, flu symptoms, muscle pain, diarrhea, or constipation. You may also have joint or back pain."

Answered by AI

Clinical Trials for Actonel

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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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 Saskatchewan

Hassan Vatanparast, MD, PhD

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