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A randomised controlled clinical trial to evaluate the anti-osteolytic agent clodronate for the prevention of the development of bone metastases in patients with primary breast cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN83688026
Enrollment
1000
Registered
2006-02-01
Start date
1989-01-01
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast cancer Cancer Breast cancer

Interventions

Clodronate 1600 mg taken orally per day for two years

Sponsors

Royal Marsden Hospital (UK), secondary sponsor Schering (Germany)
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: Histologically or cytologically confirmed primary operable breast cancer with no evidence of metastases

Exclusion criteria

Exclusion criteria: 1. Significant renal, hepatic or non-malignant bone disease 2. Previous history of malignant disease 3. Prior bisphosphonate use

Design outcomes

Primary

MeasureTime frame
Time to first bone metastases over five-year study period

Secondary

MeasureTime frame
Survival

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 22, 2026