Risedronate Clinical Trials

Size	Price	Qty
50mg	USD 97

Clinical Trials

Multiple completed Phase 1 and Phase 2 clinical trials, sponsored by industry organizations including Warner Chilcott and Sanofi, have evaluated the pharmacokinetic profile, bioavailability, and therapeutic efficacy of risedronate. Conducted in healthy adult volunteers, non-lactating or surgically sterile females, and patients with postmenopausal osteoporosis, these studies investigated novel delayed-release formulations, monthly dosing schedules, and the impact of co-administered food or calcium supplements on drug absorption.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT00918749	Completed	Postmenopausal Osteoporosis	Warner Chilcott	2009-05	Phase 2
NCT00868907	Completed	Healthy	Warner Chilcott\|Sanofi	2009-03	Phase 1
NCT00717145	Completed	Postmenopausal\|Non-lactating\|Surgically Sterile	Warner Chilcott\|Sanofi	2008-07	Phase 1

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Risedronate is a pyridinyl bisphosphonate that selectively binds to hydroxyapatite crystals within the bone matrix and inhibits farnesyl pyrophosphate synthase, thereby disrupting the mevalonate pathway essential for lipid prenylation. This enzymatic block triggers osteoclast apoptosis and halts bone turnover, effectively mitigating pathologically increased bone resorption observed in conditions such as 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>).