NCT00334139

Brief Summary

Bisphosphonates have been used extensively in the treatment and the prevention of skeletal complications associated with bone metastases in patients with breast cancer and prostate cancer. The purpose of this study is to assess the effect of zoledronic acid patients with prostate cancer or breast cancer and bone metastasis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
411

participants targeted

Target at P75+ for phase_4 prostate-cancer

Timeline
Completed

Started May 2006

Typical duration for phase_4 prostate-cancer

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

May 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 2, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 6, 2006

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

February 7, 2017

Status Verified

February 1, 2017

Enrollment Period

3.2 years

First QC Date

June 2, 2006

Last Update Submit

February 3, 2017

Conditions

Prostate CancerBreast CancerBone Metastasis

Keywords

serum bone markersbone metastasisprostate cancerbreast cancerquality of lifebisphosphonates

Outcome Measures

Primary Outcomes (1)

  • Bone turnover assessed by bone turnover parameters

    every 30 days

Secondary Outcomes (5)

  • Pain

    every 30 days

  • Change in prostate specific antigen

    every 30 days

  • Quality of Life

    every 30 days

  • Correlation between pain and bone turnover

    at end of study

  • Correlation between bone complications and bone turnover

    end of study

Study Arms (1)

zoledronic acid

EXPERIMENTAL
Drug: Zoledronic Acid

Interventions

Zoledronic AcidDRUG

every 4 weeks for 4 months

Also known as: ZOL446
zoledronic acid

Eligibility Criteria

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

You may qualify if:

  • Prostate cancer with at least one cancer-related bone lesion with or without hormonal treatment.
  • Breast cancer with at least one cancer-related bone lesion
  • Negative pregnancy test at screening in case of child-bearing potential and Performance status ECOG 0-2
  • Normal liver and kidney function
  • Prior surgery, chemotherapy and radiotherapy is allowed. At least 4 weeks must have elapsed since the completion of surgery, chemotherapy and radiotherapy to breast or bone.

You may not qualify if:

  • Prior treatment with bisphosphonates within 6 months before study start, and during treatment with zoledronic acid. Known hypersensitivity to zoledronic acid or other bisphosphonates. Corrected (adjusted for serum albumin) serum calcium concentration \< 8.0 mg/dl (2.00 mmol/L) or ≥12.0mg/dl (3.00 mmol/L)
  • Current/active dental problems including
  • infection of the teeth or jawbone
  • dental or fixture trauma
  • current or previous osteonecrosis of the jaw
  • exposed bone in the mouth
  • slow healing after dental procedures
  • recent (within 6 weeks) or planned dental or jaw surgery (extraction, implants)
  • Patients with clinically symptomatic brain metastases. Severe physical or psychological concomitant diseases expected to impair compliance with the provisions of the study protocol or impair the assessment of drug of patient safety
  • Clinically significant ascites, NYHA III or IV, cardiac failure, clinically relevant pathologic findings in ECG
  • History of diseases with influence on bone metabolism such as Paget´s disease and primary hyperparathyroidism and with need of treatment for osteoporosis (defined according to DVO, T-Score ≤2.5).
  • Previous radiation therapy to bone (including therapeutic radioisotopes such as strontium 89) within 1 month

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novartis Investigative Site

Ulm, Germany

Location

Related Publications (1)

  • Thadepalli H, Gorbach SL, Broido PW, Norsen J, Nyhus L. Abdominal trauma, anaerobes, and antibiotics. Surg Gynecol Obstet. 1973 Aug;137(2):270-6. No abstract available.

    PMID: 4723349RESULT

MeSH Terms

Conditions

Prostatic NeoplasmsBreast Neoplasms

Interventions

Zoledronic Acid

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

DiphosphonatesOrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmeceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2006

First Posted

June 6, 2006

Study Start

May 1, 2006

Primary Completion

July 1, 2009

Study Completion

July 1, 2009

Last Updated

February 7, 2017

Record last verified: 2017-02

Locations

DE(1)