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Completed

NCT Number: NCT00489905

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

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.

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Key information

Conditions

Prostatic Neoplasms Bone Density Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Urogenital Diseases Urogenital Neoplasms

Age range

50 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Department of Urology, Prince of Wales Hospital

Hong Kong, China

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

Zolderonic acid (Zometa)

Drug

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

Sponsors and collaborators

Lead sponsor

Hospital Authority, Hong Kong

Other Gov

Collaborators

  • Baxter Healthcare Corporation

Registry information

Official study title

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

Important dates

Study start
2005
Study completion
2008
First posted
Jun 21, 2007
Registry last updated
Oct 23, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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