Clodronate Disodium Clinical Trials

Size	Price	Qty
50mg	USD 97
1g	USD 670

Clinical Trials

Multiple clinical trials evaluate clodronate disodium across oncological, rheumatological, and orthopedic conditions, including breast cancer, knee osteoarthritis, postmenopausal osteoporosis, radiation-induced brachial plexopathy, bone neoplasms, multiple myeloma, osteolysis, and aseptic loosening of hip prostheses. Sponsored by pharmaceutical companies, research networks, and academic healthcare centers, these studies encompass Early Phase 1 through Phase 3 evaluations alongside trials of unspecified phase. The body of research spans various recruitment statuses, including completed, active not recruiting, withdrawn, and unknown.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT07116252	ACTIVE_NOT_RECRUITING	Irrigation Solution; Postoperative Pain; Inflammation; Endodontic Treatment	Suez Canal University	2023-08-20
NCT06263517	UNKNOWN	Osteoarthritis of Knee	SPA Società Prodotti Antibiotici S.p.A.	2023-10-12	PHASE2; PHASE3
NCT00127205	COMPLETED	Breast Cancer	SWOG Cancer Research Network	2005-07	PHASE3
NCT00658268	COMPLETED	Aseptic Loosening of the Hip Prosthesis	Region Skane	2008-03	PHASE2
NCT01291433	COMPLETED	Radiation Induced Brachial Plexopathy	Assistance Publique - Hôpitaux de Paris	2011-03	PHASE3
NCT03803839	COMPLETED	Hip Arthrosis	University of Oulu	2004-03-26	EARLY_PHASE1
NCT01348243	COMPLETED	Postmenopausal Osteoporosis	Chiesi Farmaceutici S.p.A.	2011-10	PHASE3
NCT00009945	COMPLETED	Breast Cancer	NSABP Foundation Inc	2001-01	PHASE3
NCT00877097	COMPLETED	Osteoporosis	Kuopio University Hospital	1996-07
NCT00003232	COMPLETED	Pain; Prostate Cancer; Quality of Life	NCIC Clinical Trials Group	1997-11-24	PHASE3

(data from https://clinicaltrials.gov, updated on 2025-08-11)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Clodronate disodium is a non-nitrogenous bisphosphonate that selectively binds hydroxyapatite in bone tissue and is metabolized into cytotoxic non-hydrolyzable ATP analogs within osteoclasts, thereby disrupting mitochondrial energy production and triggering osteoclast apoptosis. This targeted inhibition of osteoclast activity stops pathological bone resorption, directly supporting its clinical utility in mitigating skeletal complications associated with postmenopausal osteoporosis, bone neoplasms, and breast cancer metastases.

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>).