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A Pilot Trial of Intravenous Pamidronate for Low Back Pain


Phase 1/Phase 2
21 Years
N/A
Not Enrolling
Both
Chronic Low Back Pain

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Trial Information

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

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Principal Investigator

Marco Pappagallo, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mount Sinai School of Medicine

Authority:

United States: Food and Drug Administration

Study ID:

06-0782

NCT ID:

NCT01210599

Start Date:

April 2004

Completion Date:

October 2009

Related Keywords:

  • Chronic Low Back Pain
  • Back Pain
  • Bisphosphonate
  • Pamidronate
  • Bone Pain
  • Back Pain
  • Low Back Pain

Name

Location

Mount Sinai Medical CenterNew York, New York  10029