Etidronic acid

Overview

Etidronic acid is a first generation bisphosphonate similar to clodronic acid and tiludronic acid. These drugs were developed to mimic the action of pyrophosphate, a regulator of calcification and decalcification. Etidronate’s use has decreased over the years in favor of the third generation, nitrogen containing bisphosphonate zoledronic acid, ibandronic acid, minodronic acid, and risedronic acid. Etidronic acid was granted FDA approval on 1 September 1977.

Indication

Etidronate is indicated to treat Paget's disease of bone, as well as the treatment and prevention of heterotropic ossification after total hip replacement of spinal cord injury.

Associated Conditions

Heterotopic Ossification (HO)
Paget's Disease of Bone

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
The Prevention of Systemic Ectopic Mineralization in Pseudoxanthoma Elasticum	2023/04/27	NCT05832580	Phase 3	Recruiting	UMC Utrecht
A randomized, placebo-controlled, double blind trial to study the effects of Etidronate on ectopic CALCIfication in FAhr’s Disease or syndrome: CALCIFADE trial	2022/12/22	2024-512300-19-00	Phase 2	Recruiting	Universitair Medisch Centrum Utrecht
Etidronate for Arterial Calcifications Due to Deficiency in CD73 (ACDC)	2012/04/25	NCT01585402	Phase 2	Completed	National Heart, Lung, and Blood Institute (NHLBI)
Observational Study of Incidence Rates of Esophageal Cancer in Women Taking Medications for the Prevention or Treatment of Osteoporosis (MK-0217A-352)	2010/03/01	NCT01077817	N/A	Completed	Organon and Co

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
Etidronate Disodium Tablets	四川彩虹制药有限公司	国药准字H10960307	化学药品	片剂	5/29/2020

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

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