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CompletedNCT00489905Updated Oct 23, 2013

Study on Evaluation of Zoledronic Acid to Prevent Bone Loss in Men Receiving Androgen Deprivation Therapy for Prostate Cancer

An interventional study of Zolderonic acid (Zometa) in Prostatic Neoplasms and Bone Density, sponsored by Hospital Authority, Hong Kong. Completed at 1 site in China. Open to male participants aged 50 Years to 80 Years. Per ClinicalTrials.gov, last updated 2013-10-23.

Sponsored by Hospital Authority, Hong Kong · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Non-randomized
Ages
50 Years to 80 Years
Sex
Male
01

Study 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.

02

Conditions studied

  • Prostatic Neoplasms
  • Bone Density

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Keywords

  • prostate cancer
  • bone mineral density
03

In context

Prostatic Neoplasms

6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.

This study's planned enrollment of 24 is below the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

Hospital Authority, Hong Kong is the lead sponsor of 73 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 80 Years
Sexes eligible
Male

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
24 participants (estimated)

Interventions

  • DrugZolderonic acid (Zometa)
06

What researchers measure

Primary outcomes

  1. Bone mineral density of lumber spine

    Time frame: 12 months after administration of zolderonic acid

  2. Bone mineral density of femoral neck

    Time frame: 12 months after administration of zolderonic acid

Secondary outcomes

  1. Change in serum creatinine, calcium, phosphate and alkaline phosphatase

    Time frame: From time of enrollment to 3 months after the last intervention

  2. Change in creatinine clearance

    Time frame: From time of enrollment to 3 months after the last intervention

07

Study locations

1 site
  • Department of Urology, Prince of Wales Hospital
    Hong Kong, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 23, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00489905
Lead sponsor
Hospital Authority, Hong Kong
Collaborators
Baxter Healthcare Corporation
First posted
Jun 21, 2007
Start date
Apr 2005
Completion
May 2008
Last update
Oct 23, 2013

Study contacts

Chi Fai Ng, Dr
principal investigator · Department of Surgery, Division of Urology, The Chinese University of Hong Kong
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2013. You cannot join it, but the record below documents what was studied.

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