NCT00375648

Brief Summary

This study will evaluate the efficacy and safety of 4 mg zoledronic acid administered intravenously every 3-4 weeks in the treatment of bone metastases-related pain in patients with prostate cancer.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
61

participants targeted

Target at below P25 for phase_3 pain

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

June 1, 2005

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

September 11, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 13, 2006

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
Last Updated

June 2, 2017

Status Verified

May 1, 2017

Enrollment Period

2.1 years

First QC Date

September 11, 2006

Last Update Submit

May 31, 2017

Conditions

Pain

Keywords

ProstateCancerBone metastasesZoledronic acidBone metastases-related painProstate cancer

Outcome Measures

Primary Outcomes (1)

  • 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 (8)

  • 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

  • To evaluate the pain variation with BPI (=Brief Pain Inventory) and correlate with VAS (=Visual Analog Scale)

    every 3 or 4 weeks during 12 to 16 weeks

  • To evaluate the use of analgesic (analgesic score) and the number of patients needing an analgesic radiotherapy between V1 and V5

    every 3 or 4 weeks during 12 to 16 weeks

  • To evaluate the duration of responses

    at 12 weeks or at 16 weeks (end of treatment)

  • +3 more secondary outcomes

Study Arms (1)

zoledronate

EXPERIMENTAL
Drug: Zoledronic acid

Interventions

Zoledronic acidDRUG
zoledronate

Eligibility Criteria

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

You may qualify if:

  • Histologically proven adenocarcinoma of the prostate
  • Bone-scan documented metastases
  • Age \> 18 years
  • Life expectancy \> 3 months
  • Written informed consent

You may not qualify if:

  • 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.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novartis Investigative Site

Monpellier, France

Location

MeSH Terms

Conditions

PainNeoplasmsProstatic Neoplasms

Interventions

Zoledronic Acid

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsGenital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

DiphosphonatesOrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 11, 2006

First Posted

September 13, 2006

Study Start

June 1, 2005

Primary Completion

July 1, 2007

Last Updated

June 2, 2017

Record last verified: 2017-05

Locations

FR(1)