Trial information
A Study of Load-Dose Intravenous Bondronat (Ibandronate) on Bone Pain in Patients With Breast Cancer and Metastatic Bone Disease.
Status: Completed
Protocol number: ML20570
Sponsor: N.V. Roche S.A.
Company division: Pharmaceutical
Official Scientific Title: An open-label study of the effect of a loading dose of Bondronat on bone pain in patients with breast cancer and skeletal metastases experiencing moderate to severe pain.
Brief summary: This study will evaluate the efficacy of loading dose intravenous Bondronat in reducing pain and the use of analgesics in patients with breast cancer and metastatic bone disease experiencing moderate to severe pain. Patients will receive an intravenous infusion of 6mg Bondronat on 3 successive days. The anticipated time on study treatment is <3 months, and the target sample size is <100 individuals. Target sample size is 50.
Study phase: II
Study type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Single Group; Safety/Efficacy study
Condition: Pain; Bone Neoplasms; Neoplasm Metastasis
Intervention type: Drug
Intervention name: ibandronate[Bondronat]
Primary outcome: 1. Pain response (>=25% decrease in mean pain score over a 7 day period compared to mean pain score over 3 day baseline period, and <=10% increase in mean analgesic consumption).
Key secondary outcomes: 1. Efficacy: average pain score during day, and pain score at rest. Safety: AEs, laboratory parameters. QoL: FACT-BP on days 0, 7 and 28.
Inclusion criteria:
- adult patients, >=18 years of age;
- breast cancer;
- bone metastases;
- mean pain score >=4 during 3 day baseline period, corresponding to areas of bone metastases;
- stable dose of analgesics over a 3 day baseline period;
- adequate renal function.
Exclusion criteria:
- patients who have received a bisphosphonate within 3 weeks of start of baseline period;
- radiotherapy to bone within 28 days prior to study start;
- patients with an uncontrolled infection.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: February, 2007
Trial registration date: 10/17/2006
Date last updated: 8/29/2008
Link to trial result
This trial was conducted at the following locations:
Belgium
- Aalst
- Bonheiden
- Bruxelles
- Dendermonde
- Libramont
- Mont-Godinne
- Oostende
- Ottignies
- Tournai
