Alendronic Acid Clinical Trials

Size	Price	Qty
25mg	USD 147
1g	USD 970

Clinical Trials

Multiple clinical trials evaluate alendronic acid across early- to late-stage phases for metabolic bone disorders and oncologic conditions, including postmenopausal osteoporosis, general osteoporosis, bone turnover markers, and breast neoplasms. Academic and institutional sponsors—such as Peking University Third Hospital, Aarhus University Hospital in collaboration with the University of Aarhus, and the University of Wisconsin Madison—lead these studies. Operational stages across these trials vary, with recruitment statuses designated as not yet recruiting, completed, and terminated.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
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 2024-05-22)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Alendronic acid selectively binds to hydroxyapatite within bone matrix and inhibits farnesyl pyrophosphate synthase, which disrupts mevalonate pathway lipid synthesis required for small GTPase prenylation. This cellular blockade leads to osteoclast dysfunction and apoptosis, thereby inhibiting bone resorption and preserving skeletal structural integrity in clinical contexts such as postmenopausal osteoporosis and 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>).