Assessment of Pain and Quality of Life in Breast and Pros... | NCT00434317

Studies
Assessment of Pain and Quality of Life in Breast and Prostate Cancer Patients With Bone Metastases

NCT00434317

Sponsor

Novartis

Status

Completed

Last Update Posted

Feb 23, 2017Actual

Enrollment

80Actual

Phase

Phase 4

Conditions

Neoplasm Metastasis

Interventions

Zoledronic acid

Countries

Hungary

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

Status Module

Record Verification Date

Feb 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2005

Primary Completion Date

Apr 2008Actual

Completion Date

Not provided

First Submitted Date

Feb 9, 2007

First Submission Date that Met QC Criteria

Feb 9, 2007

First Posted Date

Feb 13, 2007Estimated

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

Feb 21, 2017

Last Update Posted Date

Feb 23, 2017Actual

Description Module

Brief Summary

This study will evaluate the safety, tolerability and efficacy of zoledronic acid administered intravenously every 3-4 weeks in patients with bone metastases from either breast cancer or prostate cancer.

Detailed Description

Not provided

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 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Actual

Label	Type	Description	Intervention Names
ZOL446	Experimental		Drug: Zoledronic acid

Name	Type	Description	Arm Group Labels	Other Names
Zoledronic acid	Drug		ZOL446

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Measurement of pain assessed by a Visual Analogue Scale (VAS)		throughout the study

Secondary Outcomes

Measure	Description	Time Frame
Quality of Life assessment at baseline and last visit		throughout the study

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria:

Ambulatory patients >18 years
Proof of breast cancer or prostate cancer
Diagnosis of at least one cancer-related bone lesion that is detectable on conventional radiographs or bone scan at screening
Negative pregnancy test
ECOG performance status of 0,1 or 2

Exclusion criteria:

Patients with abnormal renal function
Patients with clinically symptomatic brain metastases
Known hypersensitivity on zoledronic acid or other bisphosphonates
Pregnancy or lactation

Other protocol-defined inclusion/exclusion criteria may apply.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Novartis Pharmaceuticals	Novartis Pharmaceuticals	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Novartis Investigative Site		Budapest			Hungary
Novartis Investigative Site

Condition Browse Module

MeSH Terms

ID	Term
D009362	Neoplasm Metastasis
D009369	Neoplasms
D010146	Pain
D001943	Breast Neoplasms
D011471	Prostatic Neoplasms

Ancestor Terms

ID	Term
D009385	Neoplastic Processes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D009461	Neurologic Manifestations

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077211	Zoledronic Acid

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided