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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00171964
First received: September 13, 2005
Last updated: April 25, 2012
Last verified: April 2012
  Purpose

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 Intervention Phase
Pain
Neoplasm Metastasis
Cancer
Drug: Zoledronic acid in combination with therapy
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Pain reduction [ Time Frame: weekly assessments during 48 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to pain reduction [ Time Frame: weeks 0, 12, 24, 36, 48 and 60 ] [ Designated as safety issue: No ]
  • Duration of pain reduction [ Time Frame: weeks 0, 12, 24, 36, 48 and 60 ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: weeks 0, 12, 24, 36, 48 and 60 ] [ Designated as safety issue: No ]
  • Changes in parameters of bone turnover [ Time Frame: weeks 0, 12, 24, 36, 48 and 60 ] [ Designated as safety issue: No ]

Enrollment: 75
Study Start Date: May 2002
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00171964

Locations
Germany
Novartis Investigative Site
Herne, Germany
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00171964     History of Changes
Other Study ID Numbers: CZOL446EDE06
Study First Received: September 13, 2005
Last Updated: April 25, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

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

ClinicalTrials.gov processed this record on November 27, 2014