Trial information
A Study of Bondronat (Ibandronate) in Patients With Metastatic Bone Disease From Breast Cancer or Multiple Myeloma.
Status: Completed
Protocol number: ML19179
Sponsor: F Hoffman-La Roche Ltd
Company division: Pharmaceutical
Official Scientific Title: 'Evaluation of the effect of i.v. Bondronat followed by maintenance treatment with oral Bondronat on pain response in patients with bone metastases from breast cancer or multiple myeloma experiencing moderate to severe pain.'
Brief summary: This study will assess the efficacy and safety of an intravenous and oral regimen of Bondronat in patients with bone metastases from breast cancer or multiple myeloma experiencing moderate to severe pain. Bondronat will be administered as a 6mg intravenous infusion on days 1,2 and 3, followed by maintenance treatment with 50mg po daily from day 22. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals. Target sample size is
60.
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. 25% decrease in pain score compared to screening; <=25%increase in analgesic consumption compared to mean screening analgesic consumption that persists for >=6 weeks.
Key secondary outcomes: 1. Efficacy: pain response; duration of pain response; time to pain response; analgesic consumption; QOL. Safety: AEs; laboratory tests; renal safety.
Inclusion criteria:
- evidence of neoplastic disease (breast cancer, multiple myeloma);
- bone metastases;
- bone pain due to bone metastatic disease;
- normal renal function.
Exclusion criteria:
- patients who have received a bisphosphonate within 3 weeks of start of screening period;
- hypersensitivity to Bondronat;
- CNS or meningeal metastases.
Gender: Males or Females
Age limits: Min: N/A (No limit) Max: N/A (No limit)
Accepts healthy volunteers: No
Trial registration date: 05/17/2006
Date last updated: 12/2/2008
Link to trial result
This trial was conducted at the following locations:
Bosnia and Herzegovina
- Banja Luka
- Mostar
- Sarajevo
- Tuzla
