Alendronate sodium trihydrate Clinical Trials

Size	Price	Qty
2mg	USD 147
25mg	USD 297

Clinical Trials

Several clinical trials evaluate alendronate sodium trihydrate across conditions including osteoporosis, postmenopausal osteoporosis, and breast neoplasms. Led by academic and clinical sponsors such as Peking University Third Hospital, Aarhus University Hospital, Yonsei University, and the University of Wisconsin Madison, these investigations span Phase 1 through Phase 4 as well as unclassified protocols. Recruitment statuses vary from completed and terminated to not yet recruiting and unknown, highlighting clinical interest in both bone mineral disorders and investigative oncology.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05387200	UNKNOWN	Osteoporosis	Yonsei University	2021-07-02	PHASE4
NCT05645289	Not yet recruiting	Postmenopausal Osteoporosis	Peking University Third Hospital	2023-01-01	Phase 4
NCT03051620	Completed	Osteoporosis	Aarhus University Hospital\|University of Aarhus	2017-02-01	--
NCT02781805	Terminated	Breast Neoplasms	University of Wisconsin Madison\|Wisconsin Partnership Program	2016-08-05	Phase 1

(data from https://clinicaltrials.gov, updated on 2022-05-31)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Alendronate sodium trihydrate selectively inhibits farnesyl diphosphate synthase, disrupting downstream protein prenylation to induce osteoclast actin cytoskeleton breakdown and apoptosis. By suppressing osteoclast-mediated bone resorption and modulating cell adhesion, this compound exhibits clinical relevance in managing osteoporosis and postmenopausal osteoporosis as well as exploratory potential in breast neoplasms.

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>).