A Pilot Trial of Intravenous (IV) Pamidronate for Low Back Pain
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00101790|
Recruitment Status : Unknown
Verified January 2010 by Icahn School of Medicine at Mount Sinai.
Recruitment status was: Active, not recruiting
First Posted : January 14, 2005
Last Update Posted : January 7, 2010
|Condition or disease||Intervention/treatment||Phase|
|Low Back Pain||Drug: pamidronate||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||44 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||A Pilot Trial of IV Pamidronate for Low Back Pain|
|Study Start Date :||September 2003|
|Estimated Primary Completion Date :||June 2010|
|Estimated Study Completion Date :||June 2010|
|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.
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00101790
|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|