Status:
COMPLETED
A Pilot Trial of IV Pamidronate for Low Back Pain
Lead Sponsor:
Pappagallo, Marco, M.D.
Conditions:
Chronic Low Back Pain
Eligibility:
All Genders
21+ years
Phase:
PHASE1
PHASE2
Brief Summary
INTRODUCTION Pamidronate and other bisphosphonates (bisph) have an anti-nociceptive effect in animals. In humans, IV pamidronate is analgesic in patients affected by numerous painful conditions, inclu...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT01210599
Start Date
April 1 2004
End Date
October 1 2009
Last Update
October 13 2010
Active Locations (1)
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1
Mount Sinai Medical Center
New York, New York, United States, 10029