A Pilot Trial of Intravenous (IV) Pamidronate for Low Back Pain
Recruitment status was Active, not recruiting
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.
|Study Design:||Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||A Pilot Trial of IV Pamidronate for Low Back Pain|
- 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 ] [ Designated as safety issue: Yes ]
|Study Start Date:||September 2003|
|Estimated Study Completion Date:||June 2010|
|Estimated Primary Completion Date:||June 2010 (Final data collection date for primary outcome measure)|
|Active Comparator: 1||
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.
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.
|United States, New York|
|The Mount Sinai Medical Center|
|New York, New York, United States, 10029|
|Principal Investigator:||Marco Pappagallo, MD||The Mount Sinai Medical Center|