Safety and Efficacy Study of Intravenous Loading Dose of... | NCT00381368

Studies
Safety and Efficacy Study of Intravenous Loading Dose of Ibandronate in Breast Cancer Patients

NCT00381368

Sponsor

University of Turku

Status

Unknown status

Last Update Posted

Dec 4, 2006Estimated

Enrollment

Phase

Phase 2

Conditions

Breast Cancer

Interventions

Ibandronic acid

Countries

Finland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
EudraCT: 2006-000697-74

Status Module

Record Verification Date

Nov 2006

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2006

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Sep 25, 2006

First Submission Date that Met QC Criteria

Sep 25, 2006

First Posted Date

Sep 27, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 1, 2006

Last Update Posted Date

Dec 4, 2006Estimated

Name	Class
Hoffmann-La Roche	INDUSTRY

Description Module

Brief Summary

The purpose of the study is to determine the efficacy and safety of a three time repeated loading dose of intravenous ibandronate (ibandronic acid), 6 mg, in breast cancer patients with painful skeletal metastases.

Detailed Description

Painful skeletal metastases are a common site of advanced disease. For instance, in breast cancer, and despite cancer treatments (radiotherapy, cytotoxic treatment and adequate treatment of pain), the patients often need additional treatments that may relieve their symptoms. Bisphosphonates, such as ibandronic acid, have in pilot studies shown a significant decrease in pain scores, both after loading dose and after long-term treatment. In this study the safety and efficacy of an intravenous loading dose of three times 6 mg ibandronate during three consecutive days in breast cancer patients with painful skeletal metastases will be studied.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
Ibandronic acid	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Worst and average pain in movement and rest on the visual analogue scale (VAS) before the first dose, on days 2, 3, 7 and on day 28
Analgesic consumption during the same period will additionally be assessed

Secondary Outcomes

Measure	Description	Time Frame
Bone markers: serum 1CTP, serum P1NP, serum NTX on day 1 before dosing, and on days 7 and 28
World Health Organization (WHO) performance status
Safety: serum cystatin C and serum creatinine, and reporting of adverse events

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Breast cancer with presence of bone metastases
Pain score over 4 on the VAS

Exclusion Criteria:

Patients with pathological fractures or medulla compression or neuropathic pain
Patients with infection or corticosteroid treatment
Pregnant or lactating patients

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Outi Paija, MD, PhD	Contact	+358-2-3130000	52863	outi.paija@tyks.fi
Tiina Saarto, MD, PhD	Contact			tiina.saarto@hus.fi

Overall Officials

Name	Affiliation	Role
Outi Paija, MD, PhD	Dept of Oncology, Turku University Hospital, Finland	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dept of Oncology, Helsinki University Central Hospital	Not yet recruiting	Helsinki	Helsinki	00029	Finland

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077557	Ibandronic Acid

Ancestor Terms

ID	Term
D004164	Diphosphonates
D063065	Organophosphonates
D009943	Organophosphorus Compounds
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided