A randomised phase II study of a loading dose of ibandronate schedules in patients with bone metastases from breast cancer
- Conditions
- Breast cancer patients with metastatic bone diseaseCancerBreast cancer
- Registration Number
- ISRCTN11367078
- Lead Sponsor
- Greater Glasgow NHS Board, North Glasgow Division (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 44
1. Female patient aged>=18 years. Indication for the treatment of metastatic bone disease with bisphosphonates
2. ECOG performance status 0, 1 or 2. Histologically confirmed diagnosis of breast cancer
3. Radiological evidence of metastatic bone disease
4. Life expectancy of greater than 6 months
5. Normal renal function
6. Liver function tests within 2 times the upper limit of normal for the local laboratory
7. Calcium levels within normal range for local laboratory (no evidence of hypercalcaemia or hypocalcaemia)
8. Patient is not pregnant or lactating and is willing to use adequate contraception
9. Written informed consent in accordance with local requirements
1. Bisphosphonate use within 6 months
2. Previous bisphosphonate hypersensitivity
3. Change in systemic anti-cancer treatment within 3 months preceeding trial entry
4. Administration of Strontium or Sumarium within 6 months of trial entry
5. Local radiotherapy within 2 weeks of study
6. Any other bone disease: Paget's disease of bone, metabolic bone disease
7. Psychiatric condition that would preclude obtaining informed consent
8. Bone active treatment within 3 months (i.e. HRT use) but Tamoxifen permitted
9. Concurrent vitamin D or retinoids
10. Active peptic ulcer
11. Acetylsalicylic acid sensitive asthma
12. Treatment with aminoglycosides
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary study end-point is the percentage reduction in S-CTX-1 from baseline by day 5 on study
- Secondary Outcome Measures
Name Time Method The secondary study end-point is the percentage reduction in S-CTX-1 level from baseline at the end of weeks 1-8 averaged