Didronel

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

Treatment

7 FDA approvals

20 Active Studies for Didronel

What is Didronel

Etidronic acid

The Generic name of this drug

Treatment Summary

Etidronic acid is a type of medication used to regulate calcium levels in the body. It was the first drug of its kind when it was approved by the FDA in 1977, but has since been replaced by newer drugs, known as nitrogen-containing bisphosphonates. Etidronic acid is still used, but not as widely as the newer drugs.

Didronel

is the brand name

Didronel 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 Didronel Affects Patients

Etidronic acid is a medication that stops bone from breaking down. It is considered to be very safe, even when taken in large doses, and its effects can last a long time. However, it can cause issues in the upper digestive tract, so patients should be aware of this before taking it.

How Didronel works in the body

Bisphosphonates are taken into the bones, where they bind to a mineral called hydroxyapatite. Bone resorption by osteoclasts creates an acidic environment that forces the bisphosphonates out of their binding site and into the osteoclast. Once in the osteoclast, the bisphosphonates interfere with the osteoclast's ability to break down the bones. This prevents the resorption of bones by the osteoclast. Early generation bisphosphonates mimic a molecule called pyrophosphate, which cannot be broken down, and thus stops all energy-dependent functions of

When to interrupt dosage

The advocated dosage of Didronel is contingent upon the identified condition, including Total Hip Replacements, Paget's Disease of Bone and Heterotopic Ossification. The magnitude of dosage varies, as per the delivery strategy outlined in the table beneath.

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, Solution - Intravenous, Intravenous

Heterotopic Ossification

200.0 mg, , 400.0 mg, 50.0 mg/mL

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

Total Hip Replacements

200.0 mg, , 400.0 mg, 50.0 mg/mL

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

Osteitis Deformans

200.0 mg, , 400.0 mg, 50.0 mg/mL

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

Warnings

Didronel 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 Didronel.

Common Didronel 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.

Didronel Toxicity & Overdose Risk

An overdose of calcium gluconate can cause symptoms such as low calcium levels, vomiting, tingling sensations, and diarrhea. Treatment may involve managing electrolyte levels and administering intravenous calcium gluconate.

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

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

48 active clinical trials are presently examining the potential of Didronel to alleviate Heterotopic Ossification, Paget's Disease of Bone and Spinal Cord Injury.

Condition

Clinical Trials

Trial Phases

Osteitis Deformans

0 Actively Recruiting

Heterotopic Ossification

0 Actively Recruiting

Total Hip Replacements

1 Actively Recruiting

Phase 3

Spinal Cord Injury

70 Actively Recruiting

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

Didronel Reviews: What are patients saying about Didronel?

3.7

Patient Review

12/24/2013

Didronel for Glucocorticoid-Induced Osteoporosis Prevention

This treatment has been effective for me over the long term. It can be difficult to find, but it's worth seeking out.

3

Patient Review

9/13/2010

Didronel for Formation of Bone in Abnormal Place

Patient Q&A Section about didronel

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

Is etidronate a bisphosphonate?

"Etidronate falls into a category of drugs known as bisphosphonates. Its mode of action is to slow the deterioration of existing bone and the formation of new bone."

Answered by AI

Is Didronel a bisphosphonate?

"Didronel is a medicine that affects how bones are formed and broken down in the body. This can slow down the loss of bone mass, and may help to prevent fractures. Didronel is used to treat a condition called Paget's disease, which affects the bones."

Answered by AI

Is etidronate discontinued?

"This drug is not available in the U.S. The recommended dose was 7.5 mg/kg IV infusion once daily, administered for 3 consecutive days. Etidronate was designated an orphan drug by the FDA for this indication; however, etidronate therapy has been replaced with more potent bisphosphonates for this condition."

Answered by AI

What is Didronel used for?

"Etidronate isused topersona certain type of bone disease called Paget's disease. This disease weakens and deforms bones. Etidronatereduce works by slowing bone loss, helping to keep your bones strong and less likely to break. It also helps reduce bone pain from this disease."

Answered by AI

Clinical Trials for Didronel

Image of Shirley Ryan AbilityLab in Chicago, United States.

Assistive Technologies for ALS

18+
All Sexes
Chicago, IL

Many individuals with severe motor impairments rely on Assistive Technologies (ATs) or Brain-Computer Interfaces (BCIs) to interact with digital devices such as their computers. Clinicians and researchers currently lack a common framework to objectively quantify how much a given AT or BCI improves real-world function or to compare across tools. This project seeks to address this gap by developing a standardized method to objectively assess or compare the functional benefit of these tools on digital independence, i.e., the ability to independently operate computers, phones, and other digital systems, by creating a unique Digital Assessment Interface (DAI). This assessment will be a simulation of online and digital activities that prior work has determined is important to functional daily living in the digital domain. Participants will complete this assessment with various ATs and BCIs, and these scores will be used to create an index, which will be comprised of performance outcomes, clinician-reported outcomes, and patient-reported outcomes. The tool aims to quantify and compare digital task performance across devices and user populations. The primary objective of this study is to develop an index. The index will quantify functional performance of individuals using various ATs and BCIs. The secondary objectives are to extensively evaluate the psychometric properties of the index, such as the validity, responsiveness, reliability, and floor/ceiling effects both globally and across different devices and impairment levels, ensuring that it can reliably measure the impact of an AT or BCI on a user's ability to independently operate digital systems; and to characterize the familiarization and use of specific BCI and AT systems with reference to a normative healthy control population.

Recruiting
Has No Placebo

Shirley Ryan AbilityLab

Neuralink Corp

Image of HealthPartners Neuroscience Center in Saint Paul, United States.

Intranasal Insulin for Spinal Cord Injury

18 - 84
All Sexes
Saint Paul, MN

The purpose of this study is to find out whether insulin, a drug approved by the FDA for the treatment of diabetes mellitus, is safe when administered as a nasal spray (intranasally) to people who have experienced a spinal cord injury. While insulin nasal spray has been shown to be safe in many patient populations, it has not yet been studied in people with spinal cord injury. This study would be the first step to developing insulin nasal spray as a treatment for spinal cord injury in the future. This study is recruiting up to 12 individuals who have experienced a spinal cord injury at least 4 months ago to administer either 76 IU insulin nasal spray or a placebo (inactive nasal spray) at home every day for up to 24 days. Participants will be asked questions about their health and symptoms related their spinal cord injury, and will have their blood collected throughout the study. Participants who are unable to administer the medication independently must have a study partner in order to participate.

Phase 1
Recruiting

HealthPartners Neuroscience Center

Leah R Hanson, PhD

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XoMotion-R Exoskeleton for Spinal Cord Injury

18+
All Sexes
Edmonton, Canada

After spinal cord injury (SCI), many people lose their ability to walk and do not have access to equipment and assistance that could help them regain functional abilities. Furthermore, many who have the potential to regain function are further hindered by a loss of function in their upper body that limits their ability to use a walker or crutches, thus eliminating options for mobility. This study seeks to determine the safety and feasibility of the XoMotion-R, a self-balancing exoskeleton that allows people with American Spinal Injury Association Impairment Scale (AIS) rating of B-D SCI to walk hands-free in inpatient and outpatient settings. This study will examine how use of the XoMotion-R affects functional outcomes and identify setting-specific barriers and facilitators to clinical adoption. This single-arm feasibility study will recruit 8 SCI inpatients and 8 SCI outpatients whose goal is to improve their walking and incorporate the XoMotion-R into their rehabilitation sessions. Participants will work on a variety of gait tasks tailored to their functional level. The goal is to determine whether early robotic gait training can improve functional outcomes and decrease length of stay, secondary complications, and long-term disability burden.

Waitlist Available
Has No Placebo

Glenrose Rehabilitation Hospital

Jessica M D'Amico, PhD

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Spinal Stimulation + Gait Training for Spinal Cord Injury

Any Age
All Sexes
Montreal, Canada

Spinal cord injury (SCI) often results in partial or complete loss of movement. In the subacute phase (\< 6 months), the central nervous system shows increased potential for neuroplasticity, making it more responsive to rehabilitation and external stimulation. Standard care in rehabilitation centers relies on activity-based therapy (ABT), which uses intensive, task-specific training to promote recovery. Although ABT can improve mobility, its effects are often limited due to the nature of SCI and the indirect activation of neural circuits. Recent findings suggest that adding transcutaneous spinal cord stimulation (tSCS) to ABT in chronic SCI (\> 12 months) can enhance lower-limb motor recovery. This study will evaluate whether combining tSCS with gait training is safe and feasible in individuals with subacute SCI and whether it improves lower-limb motor outcomes compared with gait training alone. The investigators hypothesize that pairing gait training with tSCS early after injury will be safe and feasible and that tSCS delivered during gait training will augment leg muscle activation and lead to greater functional improvements. The study will also assess the feasibility, safety and tolerability of implementing this combined intervention in a intensive functional rehabilitation setting.

Recruiting
Senior-friendly

Institut de réadaptation Gingras-Lindsay-de-Montréal (IRGLM)

Mitacs

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Image of James J. Peters Department of Veterans Affairs Medical Center in The Bronx, United States.

Psilocybin for Depression

18+
All Sexes
The Bronx, NY

The main goal of this study is to determine if psilocybin is safe for use in people with SCI. The study will measure how people with SCI respond to three psilocybin doses: low (5mg), medium (10mg), and high (25mg). The main question the study aims to answer is: does psilocybin increase the number and severity of adverse (bad) events reported by people with SCI? These may include pain, muscle spasms, symptoms of depression, and symptoms of low or high blood pressure. The investigators will also measure how well people with SCI tolerate the psychedelic experience, and compare responses between the low (5mg), medium (10mg), and high (25mg) doses. Participants will: * Agree to be enrolled in the study for up to 13 months. * Agree to complete the seven (7) visits that are included in the psilocybin-assisted therapy. * Agree to complete follow-up study visits, including in-person visits to the James J Peters VA Medical Center, located in the Bronx, New York and remote visits. * Agree to keep a log of how they are feeling and any change in the frequency or severity of adverse events.

Phase 1 & 2
Waitlist Available

James J. Peters Department of Veterans Affairs Medical Center

Jill M Wecht, EdD

Image of Hospital for Special Surgery in New York, United States.

Suzetrigine for Total Hip Replacement

18 - 80
All Sexes
New York, NY

Total hip and knee joint replacements are among the most common and painful orthopedic procedures performed worldwide, often requiring intensive analgesia to support early ambulation and recovery. Despite widespread use of multimodal regimens, many patients still rely on opioids, which can cause sedation, nausea, constipation, and long-term dependency. Evaluating Suzetrigine in this high-need population may improve recovery trajectories, reduce opioid consumption, and support enhanced recovery protocols. Given the growing surgical volume and the emphasis on opioid-sparing strategies, rigorous investigation of Suzetrigine's efficacy in joint replacement is of high clinical value. In this study, patients undergoing primary total hip replacement will be randomized to receive either Suzetrigine or placebo for seven days, with the loading dose administered prior to surgery. The primary outcome is cumulative 48-hour opioid consumption in oral morphine equivalents starting from entry into the post-anesthesia care unit (PACU).

Phase 3
Recruiting

Hospital for Special Surgery

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Paired Associative Stimulation + Locomotor Training for Spinal Cord Injury

18 - 75
All Sexes
Chicago, IL

Locomotor recovery is one of the most important goals of individuals with spinal cord injury (SCI). Ambulatory deficits severely impact daily functions resulting in lower quality of life for people living with paralysis due to SCI. Although studies have shown that locomotor training improves locomotor function in people with chronic SCI, the benefits remain limited. Our overall hypothesis is that we can engage additional descending motor pathways, such as the reticulospinal tract (RST), to improve locomotor function in humans with chronic incomplete SCI. In this study we propose to test the effects of a novel intervention that uses repeated paired loud auditory and electrical stimulation of muscle afferents combined with locomotor training on walking speed and voluntary muscle strength.

Phase 1 & 2
Waitlist Available

Shirley Ryan AbilityLab

Dalia De Santis, PhD

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Cognixion + Apple Vision Pro for ALS

18+
All Sexes
Santa Barbara, CA

The goal of this study is refine the usability of a BCI capable communication platform. The study will take place in the United States area and will enroll up to 10 participants with late stage ALS, traumatic brain injury (TBI) or spinal cord injury (SCI) that have assistive communication and computer control needs. Each subject will receive an integrated Cognixion + Apple Vision Pro device that includes an augmented reality brain computer interface and associated communication software. The study duration is 3-4 months for each participant. The key questions that will be addressed in this study are: 1. Identify the ability of individuals with target indications to use the integrated Cognixion-Apple Vision Pro system to communicate effectively. 2. Identify the ability of such individuals to learn to use BCI, ET-BCI and other modalities, and to measure their progress over time. 3. Identify the effectiveness of the different forms of input supported by the combined Cognixion-Apple Vision Pro system (BCI, eye-tracking) in allowing such individuals to communicate and have agency. 4. Identify how input such as BCI can be optimized to suit the needs of individuals (e.g., specific frequencies that work best for an individual, SNR with different frequencies, number of targets, length of recording for each frequency) and improve overall usability. 5. Identify the extent to which personalization through a large language model (LLM) affects communication. 6. Identify the appropriate capabilities to enable through an agentic communication interface. Key measures include: ITR - information transfer rate SUS - system usability scale

Waitlist Available
Has No Placebo

Cognixion HQ

Christopher J Ullrich

Cognixion

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Motor Evoked Potential Conditioning for Spinal Cord Injury

18+
All Sexes
Charleston, SC

The purpose of this research study is to examine the effect of a brain stimulation training to improve the function of brain-spinal cord- muscle connections. Because brain-to-muscle pathways are very important in our movement control, restoring function of these pathways may improve movement problems after injuries. Spinal cord injury causes damage to the brain-to-muscle connection. However, when the injury is "incomplete", there is a possibility that some of the brain-to-muscle pathways are still connected and may be trained to improve movement function. For examining brain-to-muscle pathways, investigators use a transcranial magnetic stimulator. Investigators hope that the results of this research study will help us develop new treatments for people who have movement disabilities. This study will require about 42 visits over the first 14 weeks, and another 6 visits over an additional 3 months. Each visit will take about 1 ½ hours.

Recruiting
Has No Placebo

Medical University of South Carolina

Aiko Thompson, PhD

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