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
Secondary identifying numbers B91
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

Study website

Contact information

Dr Diana Ritchie
Scientific

Beatson Oncology Centre
Western Infirmary
Glasgow
G11 6NT
United Kingdom

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleA randomised phase II study of a loading dose of ibandronate schedules in patients with bone metastases from breast cancer
Study acronymLDIS
Study objectivesTo 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) studiedBreast cancer patients with metastatic bone disease
Intervention1. 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 typeDrug
Pharmaceutical study type(s)
PhasePhase II
Drug / device / biological / vaccine name(s)Ibandronate
Primary outcome measureThe primary study end-point is the percentage reduction in S-CTX-1 from baseline by day 5 on study
Secondary outcome measuresThe secondary study end-point is the percentage reduction in S-CTX-1 level from baseline at the end of weeks 1-8 averaged
Overall study start date11/06/2004
Completion date01/01/2007

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexFemale
Target number of participants44
Key inclusion criteria1. 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 criteria1. 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 enrolment11/06/2004
Date of final enrolment01/01/2007

Locations

Countries of recruitment

  • Scotland
  • United Kingdom

Study participating centre

Beatson Oncology Centre
Glasgow
G11 6NT
United Kingdom

Sponsor information

Greater Glasgow NHS Board, North Glasgow Division (UK)
Hospital/treatment centre

West Research Office
Administration Building
Western Infirmary
Glasgow
G11 6NT
Scotland
United Kingdom

Website http://www.ngt.org.uk/research/home.htm
ROR logo "ROR" https://ror.org/05kdz4d87

Funders

Funder type

Industry

Roche (UK)
Government organisation / For-profit companies (industry)
Alternative name(s)
F. Hoffmann-La Roche Ltd, F. Hoffmann-La Roche & Co, F. Hoffmann-La Roche AG, Roche Holding AG, Roche Holding Ltd, Roche Holding, Roche Holding A.G., Roche Holding, Limited, F. Hoffmann-La Roche & Co.
Location
Switzerland

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/04/2015 Yes No