A randomised phase II study of a loading dose of ibandronate schedules in patients with bone metastases from breast cancer

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN11367078

Enrollment

Registered

2005-09-16

Start date

2004-06-11

Completion date

Unknown

Last updated

2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast cancer patients with metastatic bone disease Cancer Breast cancer

Interventions

1. Intravenous ibandronate 12 mg day, followed on day 2 by oral ibandronate 50 mg po daily 2. Standard oral therapy of 50 mg daily from day 1

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
The primary study end-point is the percentage reduction in S-CTX-1 from baseline by day 5 on study	—

Secondary

Measure	Time frame
The secondary study end-point is the percentage reduction in S-CTX-1 level from baseline at the end of weeks 1-8 averaged	—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026