Effect of Zoledronic Acid in Patients With Renal Cell Cancer and Bone Metastasis

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: NCT00172003
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : November 18, 2016
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

September 13, 2005
September 15, 2005
November 18, 2016
September 2004
July 2009   (Final data collection date for primary outcome measure)
Rate of skeletal complications [ Time Frame: continuous ]
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Complete list of historical versions of study NCT00172003 on Archive Site
  • Time to first skeletal complication [ Time Frame: from first application of Zometa until confirmed skeletal related event (SRE) ]
  • Bone pain [ Time Frame: every 9 weeks ]
  • Time to overall progression of disease [ Time Frame: continuous ]
  • Overall survival [ Time Frame: continuous ]
  • Bone turnover parameters [ Time Frame: every 9 weeks ]
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Effect of Zoledronic Acid in Patients With Renal Cell Cancer and Bone Metastasis
Effect of Zoledronic Acid in Patients With Renal Cell Cancer and Bone Metastasis
It is the aim of this clinical study to evaluate the skeletal-related event rate under therapy with zoledronic acid in patients with renal cell cancer having at least one cancer-related bone lesion.
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Phase 4
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Renal Cell Cancer
  • Neoplasm Metastasis
Drug: Zoledronic acid
Experimental: Zoledronic acid
Zoledronic acid, dosage according to calculated creatinine clearance, administered as a 15 minute infusion every 3 weeks for 12 months. Study infusion visits should occur not earlier than the scheduled visit and no later than 3 days after the scheduled visit. The dose of zoledronic acid in patients with baseline creatinine clearance > 60 mL/min was recommended to be 4 mg infused over no less than 15 minutes.
Intervention: Drug: Zoledronic acid
Tunn UW, Stenzl A, Schultze-Seemann W, Strauss A, Kindler M, Miller K, Wirth MP, Zantl N, Schulze M, May C, Ruebel A, Birkholz K, Gruenwald V. Positive effects of zoledronate on skeletal-related events in patients with renal cell cancer and bone metastases. Can J Urol. 2012 Jun;19(3):6261-7.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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July 2009
July 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • A histologically confirmed diagnosis of renal cell carcinoma with none, one or, at maximum, 2 of the following risk factors:

    1. Karnofsky performance status less than 80%
    2. Lactate dehydrogenase greater than 1.5 times upper limit of normal
    3. Hemoglobin less than lower limit of normal
    4. Absence of nephrectomy
  • Patients must have evidence of at least one cancer-related bone lesion. If diagnosis of bone metastases in bone scan or magnetic resonance imaging (MRI)-QuickScan is unclear radiographic (X-ray, computed tomography [CT] or MRI) confirmation of at least one focus is required.
  • ECOG performance status of 0, 1 or 2.
  • Life expectancy of ≥ 6 months
  • Adequate liver function - serum total bilirubin concentration less than 1.5 x upper limit of normal value
  • Patient has given written informed consent prior to any study-specific procedures

Exclusion Criteria:

  • Only patients who received 3 or less applications of an i.v. Bisphosphonate in the past are eligible
  • Previous radiation therapy to bone (including therapeutic radioisotopes such as strontium 89) is allowed. However, other loci of bone metastasis must be present, which were not treated with radiation therapy and thus can be assessed for primary and secondary endpoints.
  • Abnormal renal function as evidenced by a calculated creatinine clearance < 30 ml/minute. Creatinine clearance (CrCl) is calculated using the Cockcroft-Gault formula: CrCl = [140-age (years)] x weight (kg) {x 0.85 for female patients} [72 x serum creatinine (mg/dL)]
  • 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 Zometa® (zoledronic acid) or other bisphosphonates
  • Pregnancy and lactation
  • Women of childbearing potential not on a medically recognized form of contraception (i.e., oral contraceptives or implants, intrauterine device [IUD], vaginal diaphragm or sponge, or condom with spermicide)
  • Use of other investigational drugs (drugs not marketed for any indication) within 30 days prior to the date of study inclusion
  • Use of other investigational drugs (drugs not marketed for any indication) within 30 days prior to the date of study inclusion
  • Participation in another trial
  • Known history or present abuse of alcohol or drugs (accepted social alcohol usage will not exclude the patient)
  • 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 and exclusion criteria may apply.

Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
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Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
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Study Director: Novartis Pharmaceuticals Novartis Pharmeceuticals
November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP