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OpenTrials
Completed

NCT Number: NCT00242554

Open-label Phase IV Clinical Trial to Evaluate the Safety and Tolerability of Zoledronic Acid in Patients With Prostate Cancer and Bone Metastases

To assess the effects of i.v. zoledronic acid 4 mg with respect to safety and tolerability

Completed

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age ≥ 18 years
  • Histological confirmed diagnosis of carcinoma of the prostate
  • Current or previous evidence of metastatic disease to the bone
  • Receiving currently or not, hormonal therapy
  • ECOG performance status of 0, 1, or 2

Exclusion criteria

  • Patients with abnormal renal function as evidenced by either a serum creatinine determination 1.5 x or greater above the upper limit of normal, or by a calculated creatinine clearance of 60 ml/minute or less.
  • Corrected serum calcium concentration, adjusted for serum albumin < 8.0 mg/dl (2.00 mmol/L).
  • WBC<3.0x10^9, ANC < 1500/mm3, Hb < 8.0 g/dL, platelets < 75 x 10^9/L.
  • Liver function tests >2.5 ULN, serum creatinine >1.5 ULN.
  • Patients with another non malignant disease, which could confound the evaluation of primary endpoints, or prevent the patient complying with the protocol.
  • Known hypersensitivity to zoledronic acid or other bisphosphonates or each of the compounds which perform the formula.

Other protocol-related inclusion / exclusion criteria may apply

Treatment and study plan

Zoledronic acid

Drug

Primary outcomes

  1. To evaluate the tolerability and safey of zoledronic acid 4mg, IV, for the following eficacy metrics: QoL, Safety (Aes) and evaluation of pain

Secondary outcomes

  1. No secondary outcomes/objectives planned

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Important dates

Study start
2002
Primary completion
2007
First posted
Oct 20, 2005
Registry last updated
Feb 23, 2017

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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