Clinical Trials

A completed Phase 4 clinical trial sponsored by the University of Valencia evaluated the therapeutic application of strontium ranelate in women with postmenopausal osteoporosis. The study directly compared strontium ranelate to raloxifene to assess patient compliance and clinical efficacy. This finalized post-marketing research focused on optimizing therapeutic adherence and disease management in postmenopausal osteoporosis.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT01544894 Completed
Postmenopausal Osteoporosis|Compliance
University of Valencia
 2009-09 Phase 4

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Strontium ranelate acts as a calcium channel inhibitor by altering (-)-desmethoxyverapamil binding with an IC50 of 0.5 mM, thereby blocking downstream calcium ion influx and disrupting calcium-dependent signaling cascades. This modulation of intracellular calcium dynamics regulates bone cell function and turnover, providing the mechanistic basis for its therapeutic use in postmenopausal osteoporosis.

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>).

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Note: Technical data last updated: Sep 1, 2026.