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CompletedNCT00242554Updated Feb 23, 2017

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

A Phase 4 interventional study of Zoledronic acid in Prostate Cancer, sponsored by Novartis Pharmaceuticals. Completed. Open to male participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-02-23.

Sponsored by Novartis Pharmaceuticals (part of Novartis) · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
150
Allocation
Non-randomized
Ages
18 Years to 80 Years
Sex
Male
01

Study summary

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

02

Conditions studied

  • Prostate Cancer

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Keywords

  • Prostate Cancer
  • Bone Metastases
  • Zoledronic acid
03

In context

Prostatic Neoplasms

6,484 studies on the registry are indexed under Prostatic Neoplasms; 1,415 are open to participants now.

This study's enrollment of 150 is above the median of 58 across 4,908 interventional studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

Novartis Pharmaceuticals is the lead sponsor of 2,711 studies on the registry; 218 are open to participants now.

Of its 582 completed or terminated interventional studies of FDA-regulated products, 435 (75%) have results posted.

Browse Novartis Pharmaceuticals studies →All Novartis studies →

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

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
150 participants

Interventions

06

What researchers measure

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

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Oct 2002 and a primary completion of Jul 2007. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 9, 2005
First posted
Oct 20, 2005
Start
Oct 2002
Primary completionActual
Jul 2007
Last update
Feb 23, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 23, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00242554
Lead sponsor
Novartis Pharmaceuticals
Responsible party
Sponsor
First posted
Oct 20, 2005
Start date
Oct 2002
Primary completion
Jul 2007
Last update
Feb 23, 2017

Study contacts

Novartis Pharmaceuticals
study director · Novartis Pharmaceuticals
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.

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Discussion

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