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

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

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 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

Resource links provided by the National Library of Medicine

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

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 ]

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

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.

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): NCT00171964

Novartis Investigative Site
Herne, Germany
Sponsors and Collaborators
Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Additional Information:
Responsible Party: Novartis Pharmaceuticals 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 ):
Bone metastasis
Analgesic consumption
Cancer patients
Cancer patients with painful bone metastasis

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