Etidronate Disodium

Osteitis Deformans, Spinal Cord Injury, Heterotopic Ossification + 1 more

Treatment

7 FDA approvals

20 Active Studies for Etidronate Disodium

What is Etidronate Disodium

Etidronic acid

The Generic name of this drug

Treatment Summary

Etidronic acid is a medication used to regulate the calcification and decalcification of bones. It is a first generation bisphosphonate, similar to clodronic acid and tiludronic acid. Etidronic acid was approved by the FDA in 1977, but over the years it has been replaced by newer, more effective third-generation nitrogen-containing bisphosphonates such as zoledronic acid, ibandronic acid, minodronic acid, and risedronic acid.

Didronel

is the brand name

Etidronate Disodium Overview & Background

Brand Name

Generic Name

First FDA Approval

How many FDA approvals?

Didronel

Etidronic acid

1977

9

Approved as Treatment by the FDA

Etidronic acid, commonly known as Didronel, is approved by the FDA for 7 uses such as Paget's Disease of Bone and Spinal Cord Injuries (SCI) .

Paget's Disease of Bone

Spinal Cord Injuries (SCI)

Heterotopic Ossification (HO)

Total Hip Replacements

Heterotopic Ossification

Spinal Cord Injury

Osteitis Deformans

Effectiveness

How Etidronate Disodium Affects Patients

Etidronic acid is a drug that stops the body from reabsorbing bones. It is generally safe and produces long-lasting effects. However, patients should be warned about potential side effects in the upper digestive tract.

How Etidronate Disodium works in the body

Bisphosphonates work to stop bone from being broken down. When they enter the bone they attach to hydroxyapatite and are released when the acidity level changes. The bisphosphonates then enter the osteoclasts, which normally break down the bone. The bisphosphonates disrupt the action of osteoclasts by blocking the ability of the cells to create ring-shaped structures of F-actin. This prevents them from breaking down the bone and stops bone resorption. First generation bisphosphonates also prevent osteoclasts from using ATP, which further stops the process of bone res

When to interrupt dosage

The recommended amount of Etidronate Disodium is contingent upon the determined condition, such as Total Hip Replacements, Paget's Disease of Bone and Heterotopic Ossification. Dosage likewise relies upon the technique of delivery delineated in the table underneath.

Condition

Dosage

Administration

Spinal Cord Injury

200.0 mg, , 400.0 mg, 50.0 mg/mL

, Oral, Tablet, Tablet - Oral, Kit; Tablet - Oral, Kit; Tablet, Solution, Intravenous, Solution - Intravenous

Heterotopic Ossification

200.0 mg, , 400.0 mg, 50.0 mg/mL

, Oral, Tablet, Tablet - Oral, Kit; Tablet - Oral, Kit; Tablet, Solution, Intravenous, Solution - Intravenous

Total Hip Replacements

200.0 mg, , 400.0 mg, 50.0 mg/mL

, Oral, Tablet, Tablet - Oral, Kit; Tablet - Oral, Kit; Tablet, Solution, Intravenous, Solution - Intravenous

Osteitis Deformans

200.0 mg, , 400.0 mg, 50.0 mg/mL

, Oral, Tablet, Tablet - Oral, Kit; Tablet - Oral, Kit; Tablet, Solution, Intravenous, Solution - Intravenous

Warnings

Etidronate Disodium has five contraindications that preclude its utilization in combination with the conditions listed in the table below.

Etidronate Disodium Contraindications

Condition

Risk Level

Notes

Esophageal Achalasia

Do Not Combine

delayed esophageal emptying

Do Not Combine

Esophageal Strictures

Do Not Combine

Esophagus

Do Not Combine

Severe Hypersensitivity Reactions

Do Not Combine

Etidronic Acid may interact with Pulse Frequency

There are 5 known major drug interactions with Etidronate Disodium.

Common Etidronate Disodium Drug Interactions

Drug Name

Risk Level

Description

Incadronic acid

Minor

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

Tiludronic acid

Minor

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

Deferasirox

Moderate

The risk or severity of gastrointestinal bleeding and gastrointestinal ulceration can be increased when Etidronic acid is combined with Deferasirox.

Parathyroid hormone

Moderate

The therapeutic efficacy of Parathyroid hormone can be decreased when used in combination with Etidronic acid.

Technetium Tc-99m oxidronate

Moderate

The risk or severity of hypocalcemia can be increased when Etidronic acid is combined with Technetium Tc-99m oxidronate.

Etidronate Disodium Toxicity & Overdose Risk

Overdosing on calcium carbonate may cause symptoms such as low calcium levels, vomiting, tingling sensations, and diarrhea. Treatment for overdose consists of managing any electrolyte imbalances and providing intravenous calcium gluconate to help relieve symptoms.

Etidronate Disodium Novel Uses: Which Conditions Have a Clinical Trial Featuring Etidronate Disodium?

48 active clinical trials are presently being conducted to assess the usefulness of Etidronate Disodium in treating Heterotopic Ossification, Paget's Disease of Bone and Spinal Cord Injury.

Condition

Clinical Trials

Trial Phases

Osteitis Deformans

0 Actively Recruiting

Heterotopic Ossification

4 Actively Recruiting

Phase 2, Phase 3, Phase 1

Total Hip Replacements

2 Actively Recruiting

Phase 3, Not Applicable

Spinal Cord Injury

82 Actively Recruiting

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

Etidronate Disodium Reviews: What are patients saying about Etidronate Disodium?

3

Patient Review

12/16/2010

Etidronate Disodium for Glucocorticoid-Induced Osteoporosis Prevention

I've been on this medication for over half a decade now and haven't seen any improvement in my bone scan.
image of drug pills surrounding a glass of water symbolizing drug consumption

Patient Q&A Section about etidronate disodium

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

What is a disadvantage of etidronate?

"Painful, itchy blisters on the skin that peel and eventually fall off. Joint and muscle pain that is severe and occasionally prevents movement. A burning, crawling, or prickling sensation under the skin. Difficulty swallowing."

Answered by AI

What are etidronate disodium tablets for?

"Etidronate is a medication used to treat Paget's disease, a condition which weakens and deforms bones. By slowing bone loss, etidronate helps make bones stronger and less likely to break. It also alleviates bone pain associated with Paget's disease."

Answered by AI

When should I take etidronate?

"You should take etidronate with a full glass of water on an empty stomach at least 2 hours before or after food."

Answered by AI

Is etidronate discontinued?

"os

This drug is no longer available in the United States. The typical dose was 7.5 mg/kg IV infusion given once every day for three days in a row. Etidronate was considered a drug for a rare condition by the FDA, but etidronate therapy has been replaced with more powerful bisphosphonates for this condition."

Answered by AI

Clinical Trials for Etidronate Disodium

Image of Vancouver General Hospital in Vancouver, Canada.

Dobutamine for Spinal Cord Injury

18 - 75
All Sexes
Vancouver, Canada

The first hours-to-day following acute traumatic cervical SCI represent a critical period of time to optimize hemodynamic management. After a spinal cord injury, cardiovascular function is affected. Maintaining blood pressure becomes is an important part of treatment as it supports recovery of the injured spinal cord. Blood pressure is most often increased using vasopressors, such as norepinephrine. Although these drugs help maintain blood flow, they may also lead to increased bleeding in the injury site, making the lesion worse. Alternatively, dobutamine, a medication that helps the heart pump more effectively, has shown to maintain blood pressure and improve prefusion at the injury site. This study will assess dobutamine capacity to maintain blood pressure acutely post injury.

Phase < 1
Waitlist Available

Vancouver General Hospital

Image of Hennepin Healthcare Research Institute in Minneapolis, United States.

Vibratory Genital Nerve Stimulation for Female Sexual Dysfunction

18 - 65
Female
Minneapolis, MN

The goal of this clinical trial is to learn if vibratory genital nerve stimulation (vGNS) can improve sexual function in women with spinal cord injury. The main question it aims to answer is: Does acute vGNS increase genital blood flow during a standardized sexual arousal assessment, as measured by laser speckle contrast imaging? Participants will: Complete a baseline in-clinic visit including two sexual arousal assessments with a vGNS session in between, while genital blood flow is measured using a non-invasive imaging device Use a vibration device at home twice weekly for 12 weeks Complete questionnaires about sexual function at baseline, during the home phase, and at a 12-week follow-up visit Attend a follow-up in-clinic visit repeating the baseline assessments

Recruiting
Has No Placebo

Hennepin Healthcare Research Institute

Image of Casa Colina Hospital and Centers for Healthcare in Pomona, United States.

Bowel Program Interventions for Spinal Cord Injury

18+
All Sexes
Pomona, CA

The goal of the study is to find out which of three different options (a suppository, a mini enema, or a transanal irrigation device) takes the least amount of time for completing bowel program amongst those who have spinal cord injuries with a neurogenic bowel. The main questions this study aims to answer are: * Does one of these tools meaningfully reduce the amount of time people with spinal cord injury need to complete their bowel programs? * Does one of these tools meaningfully reduce the number of times someone might experience incontinence or constipation? * Are participants satisfied in using these devices, and would they prefer to use the same tool at home? Researchers will compare the answers to these questions between the three different tools to improve quality of life for patients while improving the efficiency of the care provided. Participants in this study will: * Be enrolled in one of these options depending on when they are admitted to Casa Colina Hospital * Will receive the same tool for their bowel program for the majority or entirety of their stay * Will have a tracking sheet placed in their rooms for nursing to record when bowel program started and when it was completed * Will receive questionnaires when they enroll and when they finish the study on their experience with the tool and how likely they would be to use it at home

Recruiting
Has No Placebo

Casa Colina Hospital and Centers for Healthcare

Emily Rosario, PhD

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Image of Rocky Mountain Regional VA Medical Center, Aurora, CO in Aurora, United States.

Testosterone Therapy for Spinal Cord Injury

18+
Male
Aurora, CO

Spinal cord injury (SCI) results in lower limb muscle loss, bone loss, and high fat mass that impede the recovery of physical function, increase bone fracture risk, and worsen health and quality of life. These deficits result from reduced activity after SCI and may be worsened by low testosterone, which is present in many men with SCI. In older men with low testosterone who do not have SCI, testosterone therapy (TRT) is known to increase muscle mass, muscle strength, and bone mineral density, and to reduce body fat. However, it is not known if TRT is effective in men with SCI. The purposes of this study are to determine the effectiveness of TRT in men who have low testosterone and difficulty walking after chronic motor incomplete SCI and to assess whether a process in the body that changes testosterone to dihydrotestosterone (DHT; another hormone that is stronger than testosterone) impacts the effectiveness of TRT in the impaired lower limbs and in other tissues after SCI. The researchers hypothesize that TRT will improve muscle and bone in the impaired limbs of men with chronic incomplete SCI and reduce fat mass, and that finasteride (a drug that blocks that blocks a process that changes testosterone to DHT) will influence prostate symptoms but not the musculoskeletal or body composition benefits produced by TRT.

Phase 2 & 3
Waitlist Available

Rocky Mountain Regional VA Medical Center, Aurora, CO (+3 Sites)

Joshua F Yarrow, PhD MS BS

Image of The University of Chicago in Chicago, United States.

Intrathecal CE-1 for Spinal Cord Injury

18+
All Sexes
Chicago, IL

The purpose of this study is to assess the safety and tolerability of intrathecal administration of CE-1 at a weight-based dose (cells/kg BW), capped at a maximum total dose of 1×10⁸ cells in 10 mL, with administered volume calculated using M = 0.167 mL/kg BW. Study details include: The overall study duration will be up to three years. The primary endpoint will be assessed at 6 months following investigational product administration. An additional secondary endpoint will be assessed at 12 months in the form of a phone call. Study visits therefore consist of one interventional visit, an evaluation visit within two weeks post-injection, a primary endpoint follow-up visit at 6 months, and a secondary endpoint follow-up phone call at 12-months.

Phase < 1
Waitlist Available

The University of Chicago

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Rhythmic Auditory Stimulation for Spinal Cord Injury

18+
All Sexes
Sacramento, CA

This pilot study aims to evaluate the feasibility and preliminary efficacy of a wearable rhythmic auditory stimulation system, MedRhythms, for improving gait parameters in patients with motor incomplete SCI. Up to 15 participants aged 18 years or older with non-progressive SCI will be enrolled. Participants will complete supervised gait training using the MedRhythms device twice weekly during regularly scheduled physical therapy sessions over a six-week period. The device uses shoe-mounted sensors and headphones to deliver real-time individualized rhythmic auditory cues based on the user's gait pattern. Primary outcome measures include change in walking speed assessed with the 10-Meter Walk Test. Secondary outcomes include walking endurance measured by the 6-Minute Walk Test, gait parameters obtained through GAITRite analysis, and participant-reported outcomes including the Walking Index for Spinal Cord Injury II (WISCI II) and the SCI Quality of Life Satisfaction with Social Roles and Activities measure. Outcomes will be assessed at baseline, post-intervention (6 weeks), and follow-up (12 weeks). Findings from this study will provide preliminary data on the feasibility and potential clinical impact of rhythmic auditory stimulation as an adjunctive gait rehabilitation strategy for individuals with incomplete SCI.

Recruiting
Has No Placebo

UC Davis Point West

Shane Stone, MD

Image of Ohio State University in Columbus, United States.

Fermented Foods for Spinal Cord Injury

18 - 70
All Sexes
Columbus, OH

The goal of this clinical trial is to learn whether consuming a high fermented food diet improves bowel function and gut health in adults with chronic spinal cord injury (SCI). The study will also evaluate the feasibility and tolerability of consuming fermented foods daily for 10 weeks. The main questions it aims to answer are: 1. Does a high fermented food diet improve neurogenic bowel dysfunction symptoms and colonic transit in adults with SCI? 2. Does fermented food intake change gut microbiome composition, short-chain fatty acid production, and intestinal inflammation? Researchers will compare a high fermented food diet to a control diet to evaluate effects on bowel health and gut microbiome outcomes. Participants will: * Consume study foods daily for 10 weeks * Attend 2 in-person study visits * Collect stool samples at home and ship them overnight to the research team using provided collection kits and prepaid shipping materials * Complete bowel health questionnaires and dietary recalls * Undergo Sitz marker testing with abdominal X-rays to assess colonic transit * Participate in biweekly monitoring contacts throughout the study period

Recruiting
Device

Ohio State University

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