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

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

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, Senior)
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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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 

Results for CZOL446EDE06 on the Novartis Clinical Trial Results Website 

Responsible Party:	Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00171964 History of Changes
Other Study ID Numbers:	CZOL446EDE06
First Posted:	September 15, 2005
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