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Evaluation of Bone Markers as Diagnostic Tools for Early Detection of Bone Metastases in Patients With High Risk Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00391690
Recruitment Status : Completed
First Posted : October 24, 2006
Last Update Posted : November 18, 2016
Information provided by (Responsible Party):

Brief Summary:
It is the aim of this prospective, single-group, clinical study to assess whether bone parameters can be used as diagnostic tools for early detection of bone metastases in patients with high risk prostate cancer. The usefulness in monitoring zoledronic acid therapy in patients who have developed bone metastases will also be assessed.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: Zoledronic acid Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 99 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Bone Markers as Diagnostic Tools for Early Detection of Bone Metastases in Patients With High Risk Prostate Cancer
Study Start Date : February 2006
Actual Primary Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Intervention Details:
  • Drug: Zoledronic acid
    In case of bone metastases: Zoledronic acid every 4 weeks for 3 months.

Primary Outcome Measures :
  1. • To assess the relationship between change in bone parameters and bone scan with respect to bone metastases [ Time Frame: Every 3 months ]

Secondary Outcome Measures :
  1. Assessment of course of bone parameters (PINP, amino-terminal propeptide of procollagen type 1) and (ICTP, Pyridinoline cross-linked carboxyterminal telopeptide of type I collagen) [ Time Frame: Every 3 months ]
  2. Assessment of course of Prostate-specific antigen (PSA) [ Time Frame: Every 3 months ]
  3. Assessment of correlation of bone parameters and PSA [ Time Frame: Every 3 months ]
  4. Assessment of optimal intervals for bone scans based on serum markers [ Time Frame: Every 3 months ]
  5. Assessment of time to rise in bone markers PINP and ICTP [ Time Frame: Every 3 months ]
  6. • Time to detection of bone metastases in bone scan [ Time Frame: Every 3 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion criteria:

  • Patients with histologically confirmed diagnosis of prostate cancer who have not yet developed bone metastases
  • Prostate cancer patients with a rise in PSA under hormone therapy.

PSA criteria:

  • Patients who have undergone prostatectomy: any rise in PSA or
  • Patients without prostatectomy: 2 consecutive rises in PSA levels relative to a previous reference value, separated by one month. The first measurement must occur one month after the reference value and must be above the reference value. The second confirmatory measurement taken one month after the first measurement must be greater than the first measurement.
  • Previous chemotherapy or radiotherapy must have been performed ≥ 8 weeks prior to study entry.
  • Eastern Cooperative Oncology Group (ECOG) score of 0, 1 or 2 (patients that spend less than 50% of time in bed during the day)
  • Adequate liver function - serum total bilirubin concentration less than 1.5 x upper limit of normal value
  • Age: ≥ 18 years
  • Patient has given written informed consent prior to any study-specific procedures. Patients with psychiatric or addictive disorders which prevent them from giving their informed consent must not enter the study.

Exclusion criteria:

  • Prior treatment with a bisphosphonate
  • Abnormal renal function as evidenced by a calculated creatinine clearance < 30 ml/minute.
  • Corrected (adjusted for serum albumin) serum calcium concentration < 8.0 mg/dl (2.00 mmol/L) or ≥ 12.0 mg/dl (3.00 mmol/L).
  • Patients with clinically symptomatic brain metastases
  • History of diseases with influence on bone metabolism such as Paget's disease and primary hyperparathyroidism
  • Severe physical or psychological concomitant diseases that might impair compliance with the provisions of the study protocol or that might impair the assessment of drug or patient safety, e.g. clinically significant ascites, cardiac failure, NYHA III or IV, clinically relevant pathologic findings in ECG
  • Known hypersensitivity to zoledronic acid or other bisphosphonates
  • Use of other investigational drugs 30 days prior to the date of randomization
  • Known history or present abuse of alcohol or drugs
  • Subjects who, in the opinion of the investigator, are unlikely to cooperate fully during the study
  • Current active dental problems including infection of the teeth or jawbone (maxilla or mandibular); dental or fixture trauma, or a current or prior diagnosis of osteonecrosis of the jaw (ONJ), of exposed bone in the mouth, or of slow healing after dental procedures.
  • Recent (within 6 weeks) or planned dental or jaw surgery (e.g. extraction, implants)

Other protocol defined inclusion/exclusion criteria may apply.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00391690

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Novartis Investigative Site
Tuebingen, Germany
Sponsors and Collaborators
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Study Director: Novartis Pharmaceuticals Novartis Pharmeceuticals
Additional Information:
Publications of Results:
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Responsible Party: Novartis Identifier: NCT00391690    
Other Study ID Numbers: CZOL446GDE22
First Posted: October 24, 2006    Key Record Dates
Last Update Posted: November 18, 2016
Last Verified: November 2016
Keywords provided by Novartis:
Serum bone marker
Prostate cancer
Early detection of metastasis
Additional relevant MeSH terms:
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Prostatic Neoplasms
Neoplasm Metastasis
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Prostatic Diseases
Neoplastic Processes
Pathologic Processes
Zoledronic Acid
Bone Density Conservation Agents
Physiological Effects of Drugs