Open label study to establish the efficacy of intravenous loading doses of Ibandronate 6 mg in patients with lung cancer and skeletal metastased experiencing moderate to severe bone pain.
- Conditions
- Patients with lung cancer and malignant disease to bone.
- Registration Number
- EUCTR2007-000885-20-NL
- Lead Sponsor
- academic hospital Maastricht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 53
Patients with Malignant Bone Disease due to histology of cytology confirmed NSCLC.
MBD confirmed by bone scintigraphy, MRI, CT-scan, PET-scan or X-ray.
Mean bone pain score equal to or higher than 5.
Bone pain must correspond to areas of metastases on bone scinthigraphy, MRI, CT-scan, PET-scan of X-ray.
The use of at lease a NSAID or a weak opioid based on the WHO analgesic ladder step 2.
Age above 18 years.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Other active malignancies.
Nursing mothers.
Pregnancy.
Bone radiotherapy in the preceding 4 weeks
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective is to establish the efficacy of ibandronic acid in patients with lung cancer and painful metastatic bone disease and pain responses over a 7 day period. <br>;Secondary Objective: Mean WORSt PAIN scale of the Brief Pain Inventory (BPI) over time (first 7 days).<br>Interference scales of the BPI (individually and total score).<br>Analgesic consumption, expressed as Opioid equivalents.<br>WHO performance score.<br>Quality of Life. <br>;Primary end point(s): Bone pain response.
- Secondary Outcome Measures
Name Time Method