Efficacy and Safety of Zoledronic Acid in the Treatment o... | NCT00375648

Studies
Efficacy and Safety of Zoledronic Acid in the Treatment of Bone Metastases-related Pain in Patients With Prostate Cancer

NCT00375648

Sponsor

Novartis Pharmaceuticals

Status

Completed

Last Update Posted

Jun 2, 2017Actual

Enrollment

61Actual

Phase

Phase 3

Conditions

Pain

Interventions

Zoledronic acid

Countries

France

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

May 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

Jun 2005

Primary Completion Date

Jul 2007Actual

Completion Date

Not provided

First Submitted Date

Sep 11, 2006

First Submission Date that Met QC Criteria

Sep 11, 2006

First Posted Date

Sep 13, 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

May 31, 2017

Last Update Posted Date

Jun 2, 2017Actual

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 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

61Actual

Label	Type	Description	Intervention Names
zoledronate	Experimental		Drug: Zoledronic acid

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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
to measure the intensity of the pain relief of the patients at the end of treatment with a five classes score (TOTPAR = TOTal PAin Relief)		at 12 weeks or at 16 weeks (end of treatment)

Secondary Outcomes

Measure	Description	Time Frame
To measure the intensity of the pain relief of the patients with the PAR at each visit		every 3 or 4 weeks during 12 to 16 weeks
To evaluate the pain variation with VAS between V1 and V2, V3, V4, V5.		every 3 or 4 weeks during 12 to 16 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Histologically proven adenocarcinoma of the prostate
Bone-scan documented metastases
Age > 18 years
Non-controlled bone pain despite systemic anti-tumor therapy (hormone or chemotherapy) initiated at least 4 weeks before inclusion
Life expectancy > 3 months
Written informed consent

Exclusion Criteria:

New systemic anti-tumor therapy initiated less than 4 weeks before study entry or predictable need for starting a new treatment within 8 weeks
Radiation therapy on bone target lesions or bone-targeted isotope therapy (strontium or samarium) completed less than 4 weeks before study entry
Bisphosphonate therapy within 8 weeks before study entry
Abnormal renal function (serum creatinine > 2 x the upper normal limit or creatinine clearance < 30 ml/min)
Corrected serum calcium > 3 mmol/L or < 2 mmol/L
Clinically relevant hypersensitivity to zoledronic acid, or another bisphosphonate, or one component present in the formulation of the study drug
Severe concomitant medical condition that could hamper patient's quality of life or influence the interpretation of pain
Patients unable to fill in a questionnaire (neurologic or psychiatric conditions, illiteracy, etc.)

Other protocol-defined exclusion criteria may apply.

Accepts Healthy Volunteers

Sex

Male

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

Name	Affiliation	Role
Novartis Pharmaceuticals	Novartis Pharmaceuticals	Study Director

Condition Browse Module

MeSH Terms

ID	Term
D010146	Pain
D009369	Neoplasms
D011471	Prostatic Neoplasms

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D005834	Genital Neoplasms, Male

Browse Leaves

Not provided

Browse Branches

Not provided

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