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

Pain Clinical Trial

Official title:

Evaluation of the Efficacy and Tolerability of Zoledronic Acid in Combination With Radiotherapy in Patients With Advanced Osteolytic Bone Lesions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00171964
• Other study ID #: CZOL446EDE06
• Status: Completed
• Phase: Phase 4
• First received: September 13, 2005
• Last updated: May 31, 2017
• Start date: May 2002
• Est. completion date: December 2008

Study information

• Verified date: April 2012
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer
• Neoplasm Metastasis
• Pain

Intervention

Drug:
• Zoledronic acid in combination with therapy

Locations

Country	Name	City	State
Germany	Novartis Investigative Site	Herne

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain reduction		weekly assessments during 48 weeks
Secondary	Time to pain reduction		weeks 0, 12, 24, 36, 48 and 60
Secondary	Duration of pain reduction		weeks 0, 12, 24, 36, 48 and 60
Secondary	Quality of life		weeks 0, 12, 24, 36, 48 and 60
Secondary	Changes in parameters of bone turnover		weeks 0, 12, 24, 36, 48 and 60

External Links

•   Link
•   Results for CZOL446EDE06 on the Novartis Clinical Trial Results Website