Trial information
A Study to Assess the Efficacy of Intravenous/Oral Bondronat (Ibandronate) in Patients With Metastatic Bone Disease Experiencing Moderate to Severe Pain
Status: Completed
Protocol number: BO18039
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: A randomized, double-blind study of the effect of Bondronat compared with zoledronic acid on pain in patients with malignant bone disease experiencing moderate to severe pain
Brief summary: This 2 arm study will compare the efficacy of a regimen of intravenous (iv) and oral Bondronat with that of zoledronic acid in patients with malignant bone disease experiencing moderate to severe pain. Patients will be randomized to receive either Bondronat (6mg iv on days 1, 2 and 3 followed by Bondronat 5Omg po daily from day 22 to week 24) or zoledronic acid (4mg iv on day 1, and then every 3-4 weeks). The anticipated time of study treatment is 6-12 months, and the target sample size is 100-500 individuals.
Target sample size is 450.
Study phase: III
Study type: Interventional; Treatment; Randomized; Double Blind; Active; Parallel; Safety/Efficacy study
Condition: Pain; Bone Neoplasms; Neoplasm Metastasis
Intervention type: Drug
Intervention name: ibandronate [Bondronat]
Primary outcome: 1. Pain, as measured by Brief Pain Inventory and analgesic use Time frame: Week 24
Key secondary outcomes: 1. Performance score and QoL measures Time frame: Week 24
2. AEs and laboratory parameters Time frame: Throughout study
3. Opioid side effects Time frame: Throughout study
4. Skeletal-related events Time frame: Throughout study
Inclusion criteria:
- patients with malignant bone disease;
- patients with moderate to severe pain.
Exclusion criteria:
- patients who have received a bisphosphonate within 3 weeks from the signing of informed consent;
- patients receiving concurrent investigational therapy, or who have received investigational therapy within 30 days of the first scheduled day of dosing;
- untreated esophagitis or gastric ulcers;
- recent or pre-scheduled radiotherapy to bone;
- patients who are pregnant or breast-feeding.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Trial registration date: 04/05/2005
Date last updated: 8/29/2008
Link to trial result
This trial was conducted at the following locations:
Argentina
- Bahia Blanca
- Buenos Aires
- Rosario
Chile
Greece
Guatemala
Hungary
Panama
Poland
Russian Federation
United Kingdom
United States
