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
Contact information
Dr Diana Ritchie
Scientific
Scientific
Beatson Oncology Centre
Western Infirmary
Glasgow
G11 6NT
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | 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 study start date | 11/06/2004 |
| Completion date | 01/01/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 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
- Scotland
- United Kingdom
Study participating centre
Beatson Oncology Centre
Glasgow
G11 6NT
United Kingdom
G11 6NT
United Kingdom
Sponsor information
Greater Glasgow NHS Board, North Glasgow Division (UK)
Hospital/treatment centre
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" |
https://ror.org/05kdz4d87 |
Funders
Funder type
Industry
Roche (UK)
Government organisation / For-profit companies (industry)
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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not 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 |
