Plain English Summary
Not provided at time of registration
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
B91
Study information
Scientific title
A randomised phase II study of a loading dose of ibandronate schedules in patients with bone metastases from breast cancer
Acronym
LDIS
Study hypothesis
To investigate if a loading dose can improve efficacy and time to biochemical response compared to standard oral therapy
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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 names
Ibandronate
Primary outcome measure
The primary study end-point is the percentage reduction in S-CTX-1 from baseline by day 5 on study
Secondary outcome measures
The secondary study end-point is the percentage reduction in S-CTX-1 level from baseline at the end of weeks 1-8 averaged
Overall trial start date
11/06/2004
Overall trial end date
01/01/2007
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
44
Participant 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
Recruitment start date
11/06/2004
Recruitment end date
01/01/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Beatson Oncology Centre
Glasgow
G11 6NT
United Kingdom
Sponsor information
Organisation
Greater Glasgow NHS Board, North Glasgow Division (UK)
Sponsor details
West Research Office
Administration Building
Western Infirmary
Glasgow
G11 6NT
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Industry
Funder name
Roche (UK)
Alternative name(s)
F. Hoffmann-La Roche Ltd, F. Hoffmann-La Roche & Co, F. Hoffmann-La Roche AG
Funding Body Type
private sector organisation
Funding Body Subtype
corporate
Location
Switzerland
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25454689