Etidronate Clinical Trials

Size	Price	Qty
50mg	USD 147
1g	USD 670

Clinical Trials

Multiple clinical trials evaluating etidronate or its derivative conjugates have completed recruitment. A Phase 1 trial, sponsored by Osteros Biomedica Ltd, investigated an etidronate-cytarabine conjugate in patients with bone metastasis resulting from malignant tumors. Additionally, a Phase 2 trial, conducted by government institutions including the National Heart, Lung, and Blood Institute and the National Institutes of Health Clinical Center, evaluated etidronate for managing arterial calcification associated with CD73 deficiency.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02673060	Completed	Bone Metastasis	Osteros Biomedica Ltd	2014-07	Phase 1
NCT01585402	Completed	Arterial Calcification\|CD73 Deficiency	National Heart Lung and Blood Institute (NHLBI)\|National Institutes of Health Clinical Center (CC)	2012-08-20	Phase 2

(data from https://clinicaltrials.gov, updated on 2024-05-22)

Check the Etidronate product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Etidronate is a non-aminobisphosphonate compound that binds directly to hydroxyapatite mineral matrices and exhibits protein tyrosine phosphatase inhibitory activity, thereby suppressing osteoclast-mediated bone resorption and ectopic tissue mineralization. By disrupting pathologically accelerated bone turnover and vascular calcium accumulation, this pharmacological action provides a rationale for managing tumor-induced bone metastasis and arterial calcification in metabolic disorders.

Appendix RUO and cGMP Quality Standards

Quality Dimension	RUO (Research Use Only)	cGMP (Current Good Manufacturing Practice)
Clinical Applicability	Prohibited in human clinical trials or medical diagnostics.	Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status	Non-regulated grade; exempt from drug manufacturing laws.	Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment	Unclassified analytical or research laboratories.	Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control	Basic purity and activity testing.	Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation	Basic equipment calibration; no process validation required.	Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance	Vendor self-declared without required formal QMS.	Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact	High risk of IND rejection if used as a critical raw material.	Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).