Pamidronate Disodium Clinical Trials

Size	Price	Qty
25mg	USD 147

Clinical Trials

Numerous Phase 1 through Phase 4 clinical trials, sponsored by academic medical centers and public health organizations such as the National Cancer Institute and Mayo Clinic, have evaluated Pamidronate Disodium across metabolic and oncologic bone disorders. These studies investigate conditions including osteoporosis, Paget disease of bone, osteogenesis imperfecta, spondyloarthropathy, multiple myeloma, and metastatic breast cancer. While completed trials demonstrate its efficacy in managing bone pain and skeletal-related events, overall trial statuses vary, including recruiting, terminated, and withdrawn studies.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02074631	COMPLETED	Osteopenia; Osteoporosis	Masonic Cancer Center, University of Minnesota	2015-02	PHASE2
NCT02721433	COMPLETED	Breast Cancer; Prostate Cancer; Metastasis	Ottawa Hospital Research Institute	2016-08	PHASE4
NCT02594878	UNKNOWN	Immune System Disease; Musculoskeletal Disease	University of Aarhus	2015-10	PHASE2
NCT00004088	COMPLETED	Multiple Myeloma and Plasma Cell Neoplasm	City of Hope Medical Center	1999-04-13	PHASE2
NCT02313727	UNKNOWN	Ankylosing Spondylitis	Bnai Zion Medical Center	2014-12	PHASE4
NCT02544659	COMPLETED	SAPHO Syndrome	Peking Union Medical College Hospital	2015-10	PHASE1
NCT01907880	COMPLETED	Breast Cancer	Ottawa Hospital Research Institute	2012-08	PHASE4
NCT01799616	UNKNOWN	Intervertebral Disc Degeneration; Modic I Discopathy; Back Pain; Low Back Pain; Magnetic Resonance Imaging (MRI)	University Hospital, Clermont-Ferrand	2013-01	PHASE2
NCT02101164	WITHDRAWN	Solid Tumor; Metastatic Bone Disease	Amgen	2014-11	PHASE4
NCT00083382	COMPLETED	Multiple Myeloma	University of Arkansas	1998-12	PHASE2
NCT00005901	COMPLETED	Osteogenesis Imperfecta	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	2000-06	PHASE3
NCT01067989	TERMINATED	Chemotherapy; Breast Cancer, Metastatic	HaEmek Medical Center, Israel	2010-03	PHASE2
NCT01718951	COMPLETED	Spondyloarthropathy	Tuen Mun Hospital	2012-08	PHASE4
NCT00655681	COMPLETED	Osteoporosis; Cerebral Palsy; Spina Bifida; Osteopenia; Osteogenesis Imperfecta	University of New Mexico	2007-09
NCT00767169	COMPLETED	Edentatio (Toothlessness)	University Hospital, Linkoeping	2008-10	PHASE2
NCT02007915	TERMINATED	Femoral Head Avascular Necrosis	The Hospital for Sick Children	2009-07
NCT00101790	UNKNOWN	Low Back Pain	Icahn School of Medicine at Mount Sinai	2003-09	PHASE1
NCT00262392	WITHDRAWN	Heterotopic Ossification	University Hospital, Basel, Switzerland	2005-06
NCT01210599	COMPLETED	Chronic Low Back Pain	Pappagallo, Marco, M.D.	2004-04	PHASE1; PHASE2
NCT00124605	COMPLETED	Refractory Multiple Myeloma; Unspecified Adult Solid Tumor, Protocol Specific	National Cancer Institute (NCI)	2005-04	PHASE1
NCT00586846	COMPLETED	Osteosarcoma	Memorial Sloan Kettering Cancer Center	2003-07	PHASE2
NCT00159419	COMPLETED	Osteogenesis Imperfecta; Osteoporosis; Paget Disease of Bone	Indiana University	1999-08	PHASE4
NCT00482378	COMPLETED	Multiple Myeloma and Plasma Cell Neoplasm; Pain	Mayo Clinic	2005-03-21	PHASE1; PHASE2
NCT00033332	COMPLETED	Multiple Myeloma and Plasma Cell Neoplasm	National Cancer Institute (NCI)	2002-04	PHASE3
NCT00164008	COMPLETED	Osteopenia; Complications of Heart-lung Transplant; Other Complications of Lung Transplant	Bayside Health	2002-10	PHASE4
NCT00738257	COMPLETED	Bone Loss	Novartis Pharmaceuticals	2000-06	PHASE4
NCT00128297	COMPLETED	Breast Cancer; Neoplasm Metastasis	Spanish Breast Cancer Research Group	2000-10-18	PHASE4
NCT00657852	COMPLETED	Bone Disease, Metabolic	Hospital Clinic of Barcelona	2000-12	PHASE4
NCT00302627	COMPLETED	Transplant Bone Disease	Providence Health & Services	1999-01
NCT00376883	COMPLETED	Multiple Myeloma	Nordic Myeloma Study Group	2000-01	PHASE3
NCT00120133	COMPLETED	Osteoporosis	Children's Mercy Hospital Kansas City	2004-12
NCT00022841	TERMINATED	Osteoporosis	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)		PHASE1; PHASE2
NCT00372710	TERMINATED	Breast Cancer With Bone Metastasis	Novartis	2002-08	PHASE3
NCT00004906	COMPLETED	Breast Cancer	Hackensack Meridian Health	1999-10	PHASE2
NCT00108394	COMPLETED	Osteopenia; Renal Osteodystrophy	US Department of Veterans Affairs	2002-10	PHASE4
NCT00548288	UNKNOWN	Arthroplasty; Mineral Density	General and Teaching Hospital Celje	2007-11	PHASE1
NCT00083408	COMPLETED	Multiple Myeloma	University of Arkansas	1998-03	PHASE2

(data from https://clinicaltrials.gov, updated on 2024-02-20)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Pamidronate disodium selectively binds to hydroxyapatite in bone matrix and inhibits farnesyl pyrophosphate synthase within the mevalonate pathway, thereby disrupting the prenylation of essential small GTPases in osteoclasts. The resulting induction of osteoclast apoptosis and suppression of bone resorption effectively mitigates bone loss and skeletal complications in clinical conditions such as osteoporosis, Paget disease of bone, and bone metastases from breast cancer or multiple myeloma.

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>).