NCT00489905

Brief Summary

The purpose of this study is to assess the effect of zoledronic acid on bone mineral density in prostatic cancer patients currently receiving androgen deprivation therapy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2005

Typical duration for not_applicable

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

April 1, 2005

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

June 20, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 21, 2007

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
Last Updated

October 23, 2013

Status Verified

October 1, 2013

First QC Date

June 20, 2007

Last Update Submit

October 22, 2013

Conditions

Prostatic NeoplasmsBone Density

Keywords

prostate cancerbone mineral density

Outcome Measures

Primary Outcomes (2)

  • Bone mineral density of lumber spine

    12 months after administration of zolderonic acid

  • Bone mineral density of femoral neck

    12 months after administration of zolderonic acid

Secondary Outcomes (2)

  • Change in serum creatinine, calcium, phosphate and alkaline phosphatase

    From time of enrollment to 3 months after the last intervention

  • Change in creatinine clearance

    From time of enrollment to 3 months after the last intervention

Interventions

Zolderonic acid (Zometa)DRUG

Eligibility Criteria

Age50 Years - 80 Years
Sexmale
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Prostate cancer patients aged between 50-80 who is having or will have ADT. Baseline BMD in between -2 standard deviation (SD) and mean of that among young adults.

You may not qualify if:

  • Patients with renal or liver problems, on calcium or other bisphosphonate therapy within six months before enrolling into the study.
  • Patients who have:
  • Serum creatinine levels \>212 µmol/L (2.4 mg/dL).
  • Creatinine clearance \<50 ml/min.
  • WBC \<4.0x109/L, Hgb \<10 g/dL, platelets \<140x109/L. Patients with known hypersensitivity to bisphosphonates. Patients with history of diseases with influence on bone metabolism, such as Page's disease of bone, primary hyperparathyroidism or osteoporosis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Urology, Prince of Wales Hospital

Hong Kong, China

Location

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

  • Chi Fai Ng, Dr

    Department of Surgery, Division of Urology, The Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

June 20, 2007

First Posted

June 21, 2007

Study Start

April 1, 2005

Study Completion

May 1, 2008

Last Updated

October 23, 2013

Record last verified: 2013-10

Locations

CN(1)