Alendronate Sodium

Osteoporosis, Osteoporosis, Postmenopause + 2 more

Treatment

5 FDA approvals

20 Active Studies for Alendronate Sodium

What is Alendronate Sodium

Alendronic acid

The Generic name of this drug

Treatment Summary

Alendronic acid is a medication used to treat certain types of osteoporosis and Paget's disease. It helps protect bones from breaking down and keeps them strong.

Fosamax

is the brand name

image of different drug pills on a surface

Alendronate Sodium Overview & Background

Brand Name

Generic Name

First FDA Approval

How many FDA approvals?

Fosamax

Alendronic acid

1996

86

Approved as Treatment by the FDA

Alendronic acid, also known as Fosamax, is approved by the FDA for 5 uses which include Osteoporosis caused by glucocorticoid and Osteoporosis .

Osteoporosis caused by glucocorticoid

Osteoporosis

Osteoporosis

Postmenopause

Paget’s Disease

Effectiveness

How Alendronate Sodium Affects Patients

Alendronic acid tablets have very little of the drug enter the body when taken orally. Most of it either enters soft tissue and bone or is eliminated from the body through urine. It does not change form when it is inside the body.

How Alendronate Sodium works in the body

Alendronic acid works by binding to the hydroxyapatite in bones. This triggers a reaction that causes acidification and the release of alendronic acid into osteoclasts, which are specialized cells responsible for bone resorption. This acid then enters the cytosol of the osteoclasts and triggers apoptosis, which is a kind of cell death. This reduces the number of osteoclasts, which in turn decreases bone resorption and can be measured by looking at levels of calcium, deoxypyridinoline, and type I collagen found in the urine.

When to interrupt dosage

The advised dosage of Alendronate Sodium is contingent on the diagnosed condition, including Osteoporosis caused by glucocorticoid, Osteogenesis Imperfecta (OI) and Paget’s Disease. The amount of dosage also varies as per the mode of delivery, outlined in the table below.

Condition

Dosage

Administration

Osteoporosis

70.0 mg, 5.0 mg, 35.0 mg, 10.0 mg, 40.0 mg, , 7.0 mg/mL

, Tablet - Oral, Oral, Tablet, Tablet, coated, Tablet, coated - Oral, Solution, Solution - Oral, Tablet, effervescent, Tablet, effervescent - Oral

Postmenopause

70.0 mg, 5.0 mg, 35.0 mg, 10.0 mg, 40.0 mg, , 7.0 mg/mL

, Tablet - Oral, Oral, Tablet, Tablet, coated, Tablet, coated - Oral, Solution, Solution - Oral, Tablet, effervescent, Tablet, effervescent - Oral

Paget’s Disease

70.0 mg, 5.0 mg, 35.0 mg, 10.0 mg, 40.0 mg, , 7.0 mg/mL

, Tablet - Oral, Oral, Tablet, Tablet, coated, Tablet, coated - Oral, Solution, Solution - Oral, Tablet, effervescent, Tablet, effervescent - Oral

Osteoporosis

70.0 mg, 5.0 mg, 35.0 mg, 10.0 mg, 40.0 mg, , 7.0 mg/mL

, Tablet - Oral, Oral, Tablet, Tablet, coated, Tablet, coated - Oral, Solution, Solution - Oral, Tablet, effervescent, Tablet, effervescent - Oral

Osteogenesis Imperfecta

70.0 mg, 5.0 mg, 35.0 mg, 10.0 mg, 40.0 mg, , 7.0 mg/mL

, Tablet - Oral, Oral, Tablet, Tablet, coated, Tablet, coated - Oral, Solution, Solution - Oral, Tablet, effervescent, Tablet, effervescent - Oral

Warnings

Alendronate Sodium has six contraindications, which means it should not be taken when any of the conditions given in the following table are present.

Alendronate Sodium Contraindications

Condition

Risk Level

Notes

Esophageal Achalasia

Do Not Combine

Hypocalcemia

Do Not Combine

Aspiration

Do Not Combine

Esophagus

Do Not Combine

Postural Orthostatic Tachycardia Syndrome

Do Not Combine

Severe Hypersensitivity Reactions

Do Not Combine

Alendronic Acid may interact with Pulse Frequency

There are 20 known major drug interactions with Alendronate Sodium.

Common Alendronate Sodium Drug Interactions

Drug Name

Risk Level

Description

Clodronic acid

Minor

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

Etidronic acid

Minor

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

Incadronic acid

Minor

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

Tiludronic acid

Minor

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

Acipimox

Moderate

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

Alendronate Sodium Toxicity & Overdose Risk

Taking alendronic acid may cause abdominal pain, acid reflux, constipation, diarrhea, indigestion, muscle pain, or nausea in up to 3% of patients. If someone takes too much alendronic acid, they should drink milk or take antacids to bind it and not induce vomiting. They may also experience low levels of calcium or phosphorous, or have problems in the upper digestive system. It is not known if alendronic acid is safe for pregnant women or for those who are breastfeeding. Studies have been done for use in children, however there was an increase in vomiting. There is no difference in

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

Alendronate Sodium Novel Uses: Which Conditions Have a Clinical Trial Featuring Alendronate Sodium?

At present, 50 active trials are conducting research to assess the potential of Alendronate Sodium in treating Osteogenesis Imperfecta (OI), Osteoporosis and Osteoporosis induced by glucocorticoids.

Condition

Clinical Trials

Trial Phases

Osteoporosis

0 Actively Recruiting

Osteoporosis

27 Actively Recruiting

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

Postmenopause

5 Actively Recruiting

Phase 2, Not Applicable

Osteogenesis Imperfecta

0 Actively Recruiting

Paget’s Disease

0 Actively Recruiting

Alendronate Sodium Reviews: What are patients saying about Alendronate Sodium?

5

Patient Review

3/15/2014

Alendronate Sodium for Decreased Bone Mass Following Menopause

Alendronate has been a game-changer for me. I went from having constant, extreme pain in my knees and legs to only occasionally feeling discomfort.

3.3

Patient Review

9/1/2019

Alendronate Sodium for Post-Menopausal Osteoporosis Prevention

I was confused by the dosing instructions on WebMD. It says to take this pill daily, but I believe that it is intended to be a weekly medication. This could be harmful to people if they follow the incorrect directions.

2

Patient Review

8/7/2021

Alendronate Sodium for Post-Menopausal Osteoporosis Prevention

I was hesitant to try this treatment because of the reviews, but I'm glad I did. My lower back pain is gone and it's all natural!

1.7

Patient Review

9/2/2014

Alendronate Sodium for Decreased Bone Mass Following Menopause

I was on this treatment for a few months, but I started having some severe side effects. Jaw pain, night sweats that were so bad my body would become cold even in hot weather. I stopped taking the medication for two months and the night sweats went away; however, as soon as I started taking it again they came back immediately. Has anyone else experienced this? If not, I don't think I can continue taking this medication because of how intolerable the night sweats are.

1.7

Patient Review

8/21/2022

Alendronate Sodium for Decreased Bone Mass Following Menopause

I was taking this medication for osteoporosis, but stopped after three months due to the onset of pulsating pain in my left arm and increased sensitivity in my teeth. I'm not sure if the shoulder pain is related, but it's become a problem since I ceased taking the medication. My doctor says this is the only option covered by my insurance, but I'm afraid to continue taking it.

1.3

Patient Review

7/13/2014

Alendronate Sodium for Decreased Bone Mass Following Menopause

This medication unfortunately caused more pain in my joints.

1.3

Patient Review

8/13/2019

Alendronate Sodium for Osteoporosis in Male Patient

As a 59 year old man with Osteoporosis, this medication made me feel incredibly worse. I was vomiting, had a sore throat, and felt more pain throughout my back than before. Needless to say, I stopped taking it very quickly.

1

Patient Review

1/29/2014

Alendronate Sodium for Post-Menopausal Osteoporosis Prevention

After taking Alendronate, I started having really severe pain in my jaw and hips. It got so bad that I had to stop the medication, but even now I'm still dealing with some pain.

1

Patient Review

7/12/2017

Alendronate Sodium for Decreased Bone Mass Following Menopause

I took one dose of this medication and woke up in the night with pain all over my body. It's now been 24 hours and I feel even worse. I'm calling my doctor now, as I don't think the benefits outweigh the side effects.

1

Patient Review

10/31/2022

Alendronate Sodium for Osteoporosis in Male Patient

I experienced painful bone side effects after just one year of using this medication. I stopped taking it four months ago, but the side effects have continued and even gotten worse.

1

Patient Review

10/3/2017

Alendronate Sodium for Decreased Bone Mass Following Menopause

I stopped taking this osteoporosis medication after only three doses. I had an intuition that it was poisonous, and after doing more research and reading other reviews, I'm convinced that it is dangerous stuff. Never touching it again.

1

Patient Review

4/10/2016

Alendronate Sodium for Post-Menopausal Osteoporosis Prevention

I was absolutely miserable while taking this medication. I felt nauseous and dizzy all the time, and had constant diarrhea.

1

Patient Review

4/3/2018

Alendronate Sodium for Decreased Bone Mass Following Menopause

As a small boned woman with pre-osteoporosis, my doctor prescribed me Alendronate Sodium USP tablets 4 years ago. Unfortunately, last year I broke my right femur and this year my left femur also broke. Out of the 70% women in my convalescent home who had taken this drug, many were there because of broken femurs. It's concerning that doctors aren't doing more to warn patients about the dangers of this medication.
image of drug pills surrounding a glass of water symbolizing drug consumption

Patient Q&A Section about alendronate sodium

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

What is alendronate sodium used for?

"Feb 1, 2023

Alendronate is used to prevent osteoporosis (thinning of the bone) in women after menopause, and to treat osteoporosis in both women and men. This medicine may also be used to prevent and treat osteoporosis caused by long-term use of corticosteroids (cortisone-like medicine)."

Answered by AI

What are the side effects of alendronate sodium?

"Nausea, stomach pain, constipation, diarrhea, gas, bloating or fullness in the stomach, change in ability to taste food, and headache may all be symptoms of a foodborne illness."

Answered by AI

How long should you take alendronate sodium tablets?

"Your doctor will consider your risk factors in determining whether you should continue to take bisphosphonates or other osteoporosis medications after the initial 3 to 5 year period."

Answered by AI

Why can't you lay down after taking alendronate sodium?

"It is important not to lie down immediately after taking alendronate, as doing so may cause the medication to come back up into the esophagus and cause damage. Instead, drink a full glass of water to help wash the medication down into the stomach."

Answered by AI

Clinical Trials for Alendronate Sodium

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

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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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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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