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

NCT00101790 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2010-01-07

No results posted yet for this study

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

Interventions

DRUG

pamidronate

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.

Sponsors & Collaborators

Principal Investigators

  • Marco Pappagallo, MD · The Mount Sinai Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-09-30
Primary Completion
2010-06-30
Completion
2010-06-30

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00101790 on ClinicalTrials.gov