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

ISRCTN	ISRCTN11367078
DOI	https://doi.org/10.1186/ISRCTN11367078
Protocol serial number	B91
Sponsor	Greater Glasgow NHS Board, North Glasgow Division (UK)
Funder	Roche (UK)

Submission date: 31/08/2005
Registration date: 16/09/2005
Last edited: 19/11/2015

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Diana Ritchie
Scientific

Beatson Oncology Centre
Western Infirmary
Glasgow
G11 6NT
United Kingdom

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	A randomised phase II study of a loading dose of ibandronate schedules in patients with bone metastases from breast cancer
Study acronym	LDIS
Study objectives	To investigate if a loading dose can improve efficacy and time to biochemical response compared to standard oral therapy
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Breast cancer patients with metastatic bone disease
Intervention	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
Intervention type	Drug
Phase	Phase II
Drug / device / biological / vaccine name(s)	Ibandronate
Primary outcome measure(s)	The primary study end-point is the percentage reduction in S-CTX-1 from baseline by day 5 on study
Key secondary outcome measure(s)	The secondary study end-point is the percentage reduction in S-CTX-1 level from baseline at the end of weeks 1-8 averaged
Completion date	01/01/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target sample size at registration	44
Key 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
Key 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
Date of first enrolment	11/06/2004
Date of final enrolment	01/01/2007

Locations

Countries of recruitment

United Kingdom
Scotland

Study participating centre

Beatson Oncology Centre

Glasgow
G11 6NT
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/04/2015		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Study website	Study website	11/11/2025	11/11/2025	No	Yes