Trial information
A Study of Bondronat (Ibandronate) in Patients With Metastatic Bone Disease
Status: Completed
Protocol number: ML18044
Sponsor: Roche Bulgaria EOOD
Company division: Pharmaceutical
Official Scientific Title: An open-label study of oral Bondronat on skeletal events in patients with metastatic bone disease
Brief summary: This study will evaluate the efficacy, safety and effect on quality of life of oral Bondronat in patients with breast cancer and metastatic bone disease. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.
Target sample size is 50.
Study phase: IV
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. Skeletal Morbidity Period Rate, (composite end-point of skeletal events per 12 week period).
Key secondary outcomes: 1. Bone pain, analgesic use, dynamics of biochemical markers for bone destruction,QoL (SF36), adverse events, gastrointestinal intolerability, withdrawal due to drug intolerance; pharmacoeconomic assessments
Inclusion criteria:
- women >=18 years of age;
- breast cancer;
- bone metastases.
Exclusion criteria:
- previous treatment with bisphosphonates within the last 3 months;
- previous treatment with gallium nitrate or metastrone;
- severely impaired renal function;
- hypocalcemia or primary hyperparathyroidism;
- brain metastases.
Gender: Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Trial registration date: 10/28/2005
Date last updated: 10/15/2008
Link to trial result
This trial was conducted at the following locations:
Bulgaria
- Plovdiv
- Shumen
- Sofia
- Stara Zagora
- Varna
- Veliko Tarnovo
