Efficacy and Tolerability of Zoledronic Acid With Radiotherapy in Pts With Advanced Osteolytic Bone Lesions
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ClinicalTrials.gov Identifier: NCT00171964 |
Recruitment Status
:
Completed
First Posted
: September 15, 2005
Last Update Posted
: June 1, 2017
|
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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 |

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:
|
- Pain reduction [ Time Frame: weekly assessments during 48 weeks ]
- Time to pain reduction [ Time Frame: weeks 0, 12, 24, 36, 48 and 60 ]
- Duration of pain reduction [ Time Frame: weeks 0, 12, 24, 36, 48 and 60 ]
- Quality of life [ Time Frame: weeks 0, 12, 24, 36, 48 and 60 ]
- 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, Senior) |
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.

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 ClinicalTrials.gov identifier (NCT number): NCT00171964
Germany | |
Novartis Investigative Site | |
Herne, Germany |
Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
Additional Information:
Responsible Party: | Novartis Pharmaceuticals |
ClinicalTrials.gov 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 ):
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 |