A Pilot Trial of Intravenous (IV) Pamidronate for Low Back Pain

NCT00101790 | Unknown Phase 1 DMC

• 1 other identifier: R01NS044845
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the test dose of pamidronate for treatment of low back pain in terms of safety, tolerability, and pain relief.

Conditions

Low Back Pain

Keywords

low back pain; pamidronate

Outcome Measures

Primary Outcomes (1)

• Best dose of pamidronate to be tested in a future large-scale study for treatment of low back pain. Criteria for best dose relate to safety/efficacy of the tested doses in this pilot trial

  Length of study

Study Arms (1)

1

ACTIVE COMPARATOR

Drug: pamidronate

Interventions

pamidronate DRUG

There will be four study groups, each with 7 subjects randomly assigned to pamidronate and 4 to placebo. The groups will occur in succession, not parallel. The dosage for group 1 will be 30 mg , 60 mg for group 2, and 90 mg for group 3. Group 4 will receive 2 treatments of 90mg IV pamidronate or placebo.

1

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females, 21 years of age or older
• Having mechanical low back pain (LBP) that is predominantly axial, i.e., subjects with low back pain with proximal radiation (above the knee), or subjects with low back pain with distal radiation of pain (below the knee), only if their low back pain component is 50% or more than their leg pain component. This pain will have been present for at least 3 months, with a minimum, average pain score of 4 on a 0-10 numeric rating scale \[NRS; a score of 4 is associated with pain of "moderate" intensity, and its use as a cutoff value is supported by the clinical relevance of similar scores found by others.
• MRI evidence of multiple level disc degeneration and vertebral changes consistent with the diagnosis of degenerative disc disease or spondylotic disease of the spine.
• Being capable of reading at a sixth-grade level.

You may not qualify if:

• Prior back surgery
• Compression fracture(s)
• Cancer that can be a possible cause of the back pain
• MRI evidence of frank disk herniation or any other abnormality or pathology (other than disc degeneration and vertebral changes consistent with the diagnosis of degenerative disc disease or spondylotic disease of the spine) regarding the probable cause of the patient's spinal pain; for example, arachnoiditis, moderate to severe spinal canal stenosis, lateral recess stenosis, congenital malformation of the spine, spinal nerve tumor, etc.
• Clinical diagnosis of relevant radiculopathic / neuropathic pain with leg pain, i.e., subjects with low back pain with distal radiation of pain (below the knee) if their leg pain component is more than 50% than their back pain component, or subjects with back pain with neurological deficits consistent with lumbosacral radiculopathy (upon examination)
• Presumptive compression of a spinal nerve root or fracture of a pars interarticularis (3) Spondylolisthesis (greater than grade one or more than 4 mm)
• A history of hypocalcemia
• Abnormal lab values:
• A baseline value for liver function that is 5% or more above the upper normal limit
• Upon the first laboratory screen, we will exclude anyone whose creatinine level is more than 5% outside the normal range. Then, of those who have acceptable creatinine levels, we will exclude anyone with a glomerular filtration rate (GFR) that is less than 60. The GFR will be calculated according to Levey et al.
• The principal investigator will use his judgment regarding excluding any individual with other abnormal lab values.
• A history of significant cardiac, hematological, renal, hepatic, metabolic, endocrinological, or neurological disease
• An allergy to bisphosphonates
• Leukopenia or thrombocytopenia
• Being pregnant or nursing

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

The Mount Sinai Medical Center

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Low Back Pain

Interventions

Pamidronate

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals

Study Officials

• Marco Pappagallo, MD

  The Mount Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 13, 2005
• First Posted: January 14, 2005
• Study Start: September 1, 2003
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: January 7, 2010

Record last verified: 2010-01

Locations

US (1)