Open label study to establish the efficacy of intravenous loading doses of Ibandronate 6 mg in patients with lung cancer and skeletal metastases experiencing moderate to severe bone pain: NVALT 9.
Completed
- Conditions
- on small cell lung cancer (NSCLC)
- Registration Number
- NL-OMON19953
- Lead Sponsor
- VALT-oncology
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 53
Inclusion Criteria
1. Patients with MBD due to histology or cytology confirmed NSCLC;
2. MBD confirmed by bone scintigraphy, MRI, CT-scan, PET scan or X-ray or cytohistological proven;
Exclusion Criteria
1. Other active malignancies;
2. nursing mothers;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 /><br><br /><br /><br>The main efficacy endpoint is bone pain response. In this study, pain response is defined as a: <br /><br>25% decrease in mean pain score over a 3-day period (day 5,6 and 7) compared to pain score at baseline as determined by the WORST PAIN” scale of the Brief Pain Inventory (BPI), with no more than a 25% increase in mean analgesic consumption over the same 3-day period compared to mean Baseline analgesic consumption. <br>
- Secondary Outcome Measures
Name Time Method 1. Mean WORST PAIN scale of the BPI over time (first 7 days);<br /><br>2. Interference scales of the BPI (individually and total score);<br /><br>3. Analgesic consumption, expressed as Opioid equivalents;<br /><br>4. WHO performance score;<br /><br>5. QoL assessment;<br /><br>6. Safety.