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

Primary Purpose

Low Back Pain

Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
pamidronate
Sponsored by
Icahn School of Medicine at Mount Sinai
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring low back pain, pamidronate

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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 Diagnosis of painful polyneuropathy, e.g., painful diabetic neuropathy Psychotic symptoms. Dr. Barry Snow, the study consulting psychologist, will train study staff to recognize these symptoms. Alcohol abuse or illicit drug use Receiving Worker's Compensation, or having a pending Worker's Compensation claim Being blind, deaf, or mute, or having a physical or mental handicap that impedes administration of instruments that will provide outcome data Weighing less than 45 kg (this is rare for an adult) Subjects who are suicidal according to the Beck Depression Inventory, or score 26 and above on the Beck Depression Inventory will be excluded from the study. Prior pamidronate treatment

Sites / Locations

  • The Mount Sinai Medical Center

Arms of the Study

Arm 1

Arm Type

Active Comparator

Arm Label

1

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
January 13, 2005
Last Updated
January 6, 2010
Sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
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1. Study Identification

Unique Protocol Identification Number
NCT00101790
Brief Title
A Pilot Trial of Intravenous (IV) Pamidronate for Low Back Pain
Official Title
A Pilot Trial of IV Pamidronate for Low Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
January 2010
Overall Recruitment Status
Unknown status
Study Start Date
September 2003 (undefined)
Primary Completion Date
June 2010 (Anticipated)
Study Completion Date
June 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Chronic low back pain-an enormous clinical problem which affects large segments of populations throughout the world-causes disability and loss of productivity, and leads to enormous costs in healthcare resources. Efforts to find relatively non-invasive therapies for individuals suffering from this problem are important. The main objective of this single-center, double-blind study is to determine the optimal dosing regimen-based on safety, tolerability, and pain relief- which should be used in planning a future, large-scale, clinical study to clarify conclusively whether chronic low back pain, unrelated to cancer, can be treated with pamidronate. Forty-four persons will be recruited for participation. There will be four study groups, each with 7 subjects randomly assigned to pamidronate and 4 to placebo. The dosage for the pamidronate participants will be 30 mg of pamidronate for the first group, 60 mg for the second group, and 90 mg for the third group. Members of the fourth group will receive 2 treatments of 90mg IV pamidronate or placebo. In this study, scientists also hope to find out if the effectiveness of pamidronate can be predicted with bone scans (a procedure used to see bone inflammation or injuries to the bone), and if improvement in performance of daily tasks is related to the amount of pamidronate a participant receives and to improvement in pain intensity, and to evaluate patient satisfaction with the pamidronate treatments.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
low back pain, pamidronate

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
44 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
pamidronate
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Time Frame
Length of study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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 Diagnosis of painful polyneuropathy, e.g., painful diabetic neuropathy Psychotic symptoms. Dr. Barry Snow, the study consulting psychologist, will train study staff to recognize these symptoms. Alcohol abuse or illicit drug use Receiving Worker's Compensation, or having a pending Worker's Compensation claim Being blind, deaf, or mute, or having a physical or mental handicap that impedes administration of instruments that will provide outcome data Weighing less than 45 kg (this is rare for an adult) Subjects who are suicidal according to the Beck Depression Inventory, or score 26 and above on the Beck Depression Inventory will be excluded from the study. Prior pamidronate treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marco Pappagallo, MD
Organizational Affiliation
The Mount Sinai Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Mount Sinai Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States

12. IPD Sharing Statement

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

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