NCT00502736

Brief Summary

This single arm study will assess the efficacy and safety of loading doses of intravenous Bondronat in patients with breast cancer and malignant bone disease experiencing moderate to severe bone pain. Patients will receive an intravenous infusion of 6mg Bondronat on days 1, 2 and 3. The anticipated time on study treatment is 3 months, and the target sample size is \<100 individuals.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 2008

Shorter than P25 for phase_2

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 17, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 18, 2007

Completed
6 months until next milestone

Study Start

First participant enrolled

January 1, 2008

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

January 22, 2014

Status Verified

January 1, 2014

Enrollment Period

1.2 years

First QC Date

July 17, 2007

Last Update Submit

January 20, 2014

Conditions

Pain; Bone Neoplasms; Neoplasm Metastasis

Outcome Measures

Primary Outcomes (1)

  • Pain and analgesic consumption

    Days 1, 7 and 14

Secondary Outcomes (3)

  • AEs and laboratory parameters

    Days 1, 4 and 7

  • Serum creatinine

    Days 1, 4 and 7

  • Karnofsky index

    Day 7

Study Arms (1)

1

EXPERIMENTAL
Drug: ibandronate [Bondronat]

Interventions

ibandronate [Bondronat]DRUG

6mg iv on days 1-3

1

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • female patients, \>=18 years of age;
  • breast cancer;
  • bone metastases;
  • moderate to severe pain;
  • adequate renal function.

You may not qualify if:

  • bisphosphonate treatment within 3 weeks of study enrollment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Unknown Facility

Ankara, 06018, Turkey (Türkiye)

Location

Unknown Facility

Ankara, 06230, Turkey (Türkiye)

Location

Unknown Facility

Istanbul, 34300, Turkey (Türkiye)

Location

Unknown Facility

Istanbul, 34390, Turkey (Türkiye)

Location

Unknown Facility

Izmir, 35100, Turkey (Türkiye)

Location

Unknown Facility

Shhiye, Ankara, 06100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

PainBone NeoplasmsNeoplasm Metastasis

Interventions

Ibandronic Acid

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsNeoplasms by SiteNeoplasmsBone DiseasesMusculoskeletal DiseasesNeoplastic ProcessesPathologic Processes

Intervention Hierarchy (Ancestors)

DiphosphonatesOrganophosphonatesOrganophosphorus CompoundsOrganic Chemicals

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2007

First Posted

July 18, 2007

Study Start

January 1, 2008

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

January 22, 2014

Record last verified: 2014-01

Locations

TU(6)