Condition category
Cancer
Date applied
09/01/2006
Date assigned
09/01/2006
Last edited
03/04/2006
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr L. Incrocci

ORCID ID

Contact details

Erasmus Medical Center
Daniel den Hoed Cancer Center
P.O. Box 5201
Rotterdam
3008 AE
Netherlands
+31 (0)10 4391421
l.incrocci@erasmusmc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

The purpose of this study is to evaluate the efficacy of oral ibandronate (versus placebo) added to the standard radiotherapy regimen for painful bone metastases to reduce pain, to reduce the need of analgesics, and to reduce skeletal-related events (impending fractures, need of repeated radiotherapy, or surgery).

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

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Prostate Cancer

Intervention

Ibandronate tablet or placebo

Intervention type

Drug

Phase

Not Specified

Drug names

ibandronate

Primary outcome measures

Primary objective will be pain reduction on the pain scale (scale 0-10) at 12 weeks of treatment. Response of treatment will be defined as a reduction of at least two points of the pain scale.

Secondary outcome measures

1. Pain reduction on the pain scale at 4-8-16-20-24 weeks of treatment. Use of analgesics at 4-8-12-16-20-24 weeks of treatment.
2. New skeletal-related events (= time to progression, including fractures, need of repeated radiotherapy, surgery)
3. Side effects at 4-8-12-16-20-24 weeks of treatment
4. Quality of Life, as measured by the EORTC-QLQ-C30 and EQ-5D, at 12-24 weeks

Overall trial start date

01/12/2005

Overall trial end date

01/12/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Karnofsky score >60%
2. Written informed consent
3. Histologically proven PC with documented (bone scintigraphy, CT scan, MRI, or conventional X-Ray) bone metastases, without spinal cord/cauda equina compression
4. Indication for analgesic radiotherapy
5. Estimated life expectancy of >6 months
6. Clinically documented painful bone metastases
7. Indication for analgesic radiotherapy for the painful bone metastases

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

80

Participant exclusion criteria

1. Previous treatment with any kind of bisphosphonates or radionuclides
2. Hypercalcemia (serum calcium level >2.65 mmol/l), hypocalcemia (serum calcium level <2.2 mmol/l), impaired renal function (creatinine >266 µmol/l; albumin >50 g/l), according to the medical charts
3. Investigational drugs within 30 days before study entry
4. Paget's disease
5. Untreated esophagitis or gastric ulcer

Recruitment start date

01/12/2005

Recruitment end date

01/12/2007

Locations

Countries of recruitment

Netherlands

Trial participating centre

Erasmus Medical Center
Rotterdam
3008 AE
Netherlands

Sponsor information

Organisation

Erasmus Medical Center (The Netherlands)

Sponsor details

Dr. Molewaterplein 40/50
Rotterdam
3000 CA
Netherlands

Sponsor type

Not defined

Website

Funders

Funder type

Industry

Funder name

Roche Nederland BV

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

Publication citations

Additional files

Editorial Notes