Condition category
Cancer
Date applied
31/08/2005
Date assigned
16/09/2005
Last edited
19/11/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.crukctuglasgow.org/

Contact information

Type

Scientific

Primary contact

Dr Diana Ritchie

ORCID ID

Contact details

Beatson Oncology Centre
Western Infirmary
Glasgow
G11 6NT
United Kingdom

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 measures

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

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

http://www.ngt.org.uk/research/home.htm

Funders

Funder type

Industry

Funder name

Roche (UK)

Alternative name(s)

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

Results - basic reporting

Publication summary

2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25454689

Publication citations

Additional files

Editorial Notes