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

NCT00171964 | Completed Phase 4 DMC

• 1 other identifier: CZOL446EDE06
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain; Neoplasm Metastasis; Cancer

Keywords

Pain; Bone metastasis; Analgesic consumption; Cancer patients; Cancer patients with painful bone metastasis

Outcome Measures

Primary Outcomes (1)

• Pain reduction

  weekly assessments during 48 weeks

Secondary Outcomes (4)

• Time to pain reduction

  weeks 0, 12, 24, 36, 48 and 60

• Duration of pain reduction

  weeks 0, 12, 24, 36, 48 and 60

• Quality of life

  weeks 0, 12, 24, 36, 48 and 60

• Changes in parameters of bone turnover

  weeks 0, 12, 24, 36, 48 and 60

Study Arms (1)

zoledronic acid + radiotherapy

EXPERIMENTAL

zoledronic acid every 4 weeks in combination with radiotherapy

Drug: Zoledronic acid in combination with therapy

Interventions

Zoledronic acid in combination with therapy DRUG

Also known as: Zometa, Zomera, Aclasta, Reclast

zoledronic acid + radiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Novartis Investigative Site

Herne, Germany

Location

Related Links

• Related Info

MeSH Terms

Conditions

Pain; Neoplasm Metastasis; Neoplasms

Interventions

Zoledronic Acid; Therapeutics

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neoplastic Processes; Pathologic Processes

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 15, 2005
• Study Start: May 1, 2002
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: June 1, 2017

Record last verified: 2012-04

Locations

DE (1)