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Efficacy and Tolerability of Zoledronic Acid With Radiotherapy in Pts With Advanced Osteolytic Bone Lesions

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ClinicalTrials.gov Identifier: NCT00171964
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : June 1, 2017
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Description
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Brief Summary:
It is the aim of this multicentric clinical study to assess the efficacy and tolerability of zoledronic acid in combination with radiotherapy in patients with advanced osteolytic bone lesions in terms of the reduction of pain and analgesic consumption.

Condition or disease Intervention/treatment Phase
Pain Neoplasm Metastasis Cancer Drug: Zoledronic acid in combination with therapy Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the Efficacy and Tolerability of Zoledronic Acid in Combination With Radiotherapy in Patients With Advanced Osteolytic Bone Lesions
Study Start Date : May 2002
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

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Arms and Interventions
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Arm Intervention/treatment
Experimental: zoledronic acid + radiotherapy
zoledronic acid every 4 weeks in combination with radiotherapy
 Drug: Zoledronic acid in combination with therapy
Other Names:
  • Zometa
  • Zomera
  • Aclasta
  • Reclast


Outcome Measures
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Primary Outcome Measures :
  1. Pain reduction [ Time Frame: weekly assessments during 48 weeks ]

Secondary Outcome Measures :
  1. Time to pain reduction [ Time Frame: weeks 0, 12, 24, 36, 48 and 60 ]
  2. Duration of pain reduction [ Time Frame: weeks 0, 12, 24, 36, 48 and 60 ]
  3. Quality of life [ Time Frame: weeks 0, 12, 24, 36, 48 and 60 ]
  4. Changes in parameters of bone turnover [ Time Frame: weeks 0, 12, 24, 36, 48 and 60 ]

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

Inclusion Criteria:

  • Diagnosis of at least one cancer-related bone lesion in cancer patients, confirmed by X-ray, MRT or computer tomography
  • Severity of pain ≥ 5 on item 3 of the BPI which is caused by the bone lesion(s) and requires radiotherapy
  • Adequate liver function - serum total bilirubin concentration less than 1.5 x the upper limit of normal value
  • Expected survival time ≥ 6 months
  • If the patient is of child-bearing potential: negative pregnancy test at screening
  • ECOG performance status of 0, 1 or 2.
  • Written informed consent

Exclusion Criteria:

  • Prior treatment with an oral bisphosphonate for more than 3 months or more than 3 intravenous (i.v.) bisphosphonate applications
  • Bisphosphonate treatment within 6 months before study start
  • Previous radiotherapy of the painful areas to be irradiated. An initiation of radiotherapy for the target area(s) up to 3 days at maximum prior to the first infusion is allowed.
  • Skeleton-related complications (e.g., pathological fractures, orthopedic intervention to treat or stabilize an osteolytic defect, spinal cord compression) during the last 3 weeks prior to the first infusion of trial medication.
  • Initiation of a new chemotherapeutic treatment regimen during the last 2 weeks prior to the first infusion of trial medication
  • 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
  • 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)
  • 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.

Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT00171964


Locations
Germany
Novartis Investigative Site
Herne, Germany
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
More Information
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Additional Information:
Related Info  This link exits the ClinicalTrials.gov site
Results for CZOL446EDE06 on the Novartis Clinical Trial Results Website  This link exits the ClinicalTrials.gov site

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00171964     History of Changes
Other Study ID Numbers: CZOL446EDE06
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: June 1, 2017
Last Verified: April 2012

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Pain
Bone metastasis
Analgesic consumption
Cancer patients
Cancer patients with painful bone metastasis

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplastic Processes
Neoplasms
Pathologic Processes
 Zoledronic acid
Diphosphonates
Bone Density Conservation Agents
Physiological Effects of Drugs