A Pilot Trial of Intravenous Pamidronate for Low Back Pain
INCLUSION STUDY CRITERIA Males and females 21 years of age or older Non-specific, mechanical
predominantly axial CLBP (subjects with below the knee pain included when the LBP component
was 50% or more than the overall pain component) Pain for at least 3 months, with a minimum
average daily pain score of 4 on a 0-10 NRS MRI evidence of disc degeneration and changes
consistent with the diagnosis of degenerative disc disease or spondylotic disease of the
spine.
EXCLUSION STUDY CRITERIA Prior back surgery, compression fracture(s), cancer as possible
cause of back pain Clinically relevant radiculopathic pain, MRI evidence of frank DISK
HERNIATION or any other abnormality or pathology regarded as the probable cause of the
patient's pain.
Defect or fracture of a pars interarticularis, spondylolisthesis with greater than 4 mm of
misalignment Having a glomerular filtration rate (GFR) less than 60 ml/min/1.73m 2 .
Hypocalcemia, significant cardiac, hematological, renal, hepatic, metabolic,
endocrinological disease Being pregnant or nursing Receiving Worker's Compensation, having a
pending legal claim Weighing less than 45 kg Subjects who score 26 and above on the Beck
Depression Inventory Prior pamidronate treatment patients who in the opinion of the study
physician have poor oral hygiene, do not have regular dental care, had a tooth extraction or
another invasive dental procedure within 3 months prior to study enrollment
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Marco Pappagallo, MD
Principal Investigator
Mount Sinai School of Medicine
United States: Food and Drug Administration
06-0782
NCT01210599
April 2004
October 2009
Name | Location |
---|---|
Mount Sinai Medical Center | New York, New York 10029 |