NCT00237159

Brief Summary

It is the aim of this clinical study to evaluate the skeletal-related event rate and tolerability of zoledronic acid in patients with prostate cancer patients and bone metastases.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
284

participants targeted

Target at P75+ for phase_4

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

October 1, 2002

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

October 9, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 12, 2005

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2005

Completed
Last Updated

March 23, 2011

Status Verified

March 1, 2011

Enrollment Period

3.2 years

First QC Date

October 9, 2005

Last Update Submit

March 21, 2011

Conditions

Prostate Cancer Patients With Bone Metastasis

Keywords

Prostate cancerBone metastasisSkeletal related event

Outcome Measures

Primary Outcomes (1)

  • Rate of skeletal complications

    3 months

Secondary Outcomes (4)

  • Time to first skeletal complication

    3 months

  • Bone pain

    3 months

  • Patients´ satisfaction with treatment

    3 months

  • Bone turnover parameters

    3 months

Study Arms (1)

ZOL446

EXPERIMENTAL
Drug: Zoledronic acid

Interventions

Zoledronic acidDRUG
Also known as: ZOL446
ZOL446

Eligibility Criteria

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

You may qualify if:

  • Signed informed consent
  • A histologically confirmed diagnosis of carcinoma of the prostate
  • Therapy with hormonal treatments (medical or surgical castration)
  • Patients must have objective evidence of metastatic disease to bone.
  • Adequate liver function - serum total bilirubin concentration less than 1.5 x upper limit of normal value
  • ECOG performance status of 0, 1 or 2

You may not qualify if:

  • Bone pain which requires strong narcotic therapy with centrally acting analgesic agents.
  • More than 3 bisphosphonate applications in patients history.
  • Previous Radiation therapy to bone (including therapeutic radioisotopes such as strontium 89) within 3 months prior to Visit 2.
  • Abnormal renal function as evidenced by
  • A calculated creatinine clearance \< 30 ml/minute. Creatinine clearance (CrCl) is calculated using the Cockcroft-Gault formula:
  • CrCl= \[140-age (years)\] x weight (kg) {x 0.85 for female patients} \[72 x serum creatinine (mg/dL)\]
  • Corrected (adjusted for serum albumin) serum calcium concentration \< 8.0 mg/dl (2.00 mmol/L) or ≥ 12.0 mg/dl (3.00 mmol/L)
  • Life expectancy \< 6 months
  • Patients with evidence in the six months prior to randomization of severe cardiovascular disease (defined as uncontrolled congestive heart failure), hypertension refractory to treatment, or symptomatic coronary artery disease uncontrolled by treatment
  • Use of other investigational drugs (drugs not marketed for any indication) within 30 days prior to the date of randomization
  • Current active dental problems including infection of the teeth or jawbone (maxilla or mandibular); dental or fixture trauma, or a current or prior diagnosis of osteonecrosis of the jaw (ONJ), of exposed bone in the mouth, or of slow healing after dental procedures.
  • Recent (within 6 weeks) or planned dental or jaw surgery (e.g. extraction, implants)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Zoledronic Acid

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital 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 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 9, 2005

First Posted

October 12, 2005

Study Start

October 1, 2002

Primary Completion

December 1, 2005

Last Updated

March 23, 2011

Record last verified: 2011-03