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

H

Hospital Authority, Hong Kong

Status

Completed

Conditions

Prostatic Neoplasms
Bone Density

Treatments

Drug: Zolderonic acid (Zometa)

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT00489905
HARECCTR0500010
CRE-2005.137-T

Details and patient eligibility

About

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.

Enrollment

24 estimated patients

Sex

Male

Ages

50 to 80 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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