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.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-000885-20-NL

Enrollment

Registered

2007-05-11

Start date

2007-07-20

Completion date

Unknown

Last updated

2024-04-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with lung cancer and malignant disease to bone.

Interventions

Trade Name: Ibandronate Product Name: Ibondronate Pharmaceutical Form: Intravenous infusion CAS Number: 138926199 Other descriptive name: SODIUM IBANDRONATE

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: Other active malignancies. Nursing mothers. Pregnancy. Bone radiotherapy in the preceding 4 weeks

Design outcomes

Primary

Measure	Time frame
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. ;Secondary Objective: Mean WORSt PAIN scale of the Brief Pain Inventory (BPI) over time (first 7 days). Interference scales of the BPI (individually and total score). Analgesic consumption, expressed as Opioid equivalents. WHO performance score. Quality of Life. ;Primary end point(s): Bone pain response.	—

Measure

Time frame

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. ;Secondary Objective: Mean WORSt PAIN scale of the Brief Pain Inventory (BPI) over time (first 7 days). Interference scales of the BPI (individually and total score). Analgesic consumption, expressed as Opioid equivalents. WHO performance score. Quality of Life. ;Primary end point(s): Bone pain response.

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Countries

Netherlands

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026