Ignite Creation Date:
2024-05-05 @ 11:39 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00101790
Status:
UNKNOWN
Last Update Posted:
2010-01-07
First Post:
2005-01-13
Brief Title:
A Pilot Trial of Intravenous IV Pamidronate for Low Back Pain
Sponsor:
Icahn School of Medicine at Mount Sinai
Organization:
Icahn School of Medicine at Mount Sinai
Study Overview
Official Title:
A Pilot Trial of IV Pamidronate for Low Back Pain
Status:
UNKNOWN
Status Verified Date:
2010-01
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None