Metastatic Bone Pain
Conditions
Interventions
Trade Name: Bondronat 6 mg/6 ml
Concentrate for solution for infusion
Product Name: Bondronat
Product Code: Ro 200-5450
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN:
Sponsors
F. Hoffmann-La Roche Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? Histological or cytological evidence of neoplastic disease (patients with prostate cancer must have progressive neoplastic disease despite at least 3 months of hormonal therapy, defined as a rise in PSA on 3 separate occasions at least 2 weeks apart or clear evidence of new bone metastases) ? Presence of bone metastases documented on bone x-ray, bone scintigram, CT scan or MRI scan ? Mean pain score of > 5 over a 7-day Baseline period on the WORST PAIN scale of the BPI ? Bone pain must correspond to areas of metastases on bone x-ray, bone scintigram, CT scan or MRI scan; patients whose pain is primarily due to visceral disease (e.g., liver metastases) or to neuropathy should be excluded. It is the responsibility of the investigator to insure that each patient’s pain is primarily due to bone metastatic disease. ? The use of at least a weak Opioid based on the WHO analgesic ladder (Appendix 13) ? No change in the type of systemic anti-neoplastic therapy for at least 6 weeks prior to Baseline period ? Age > 18 years ? WHO Performance Score of 0 – 3 (patients with PS of 3 must have their score based on bone pain, not underlying neoplastic disease) ? Adequate renal function as evidenced by a calculated creatinine clearance > 35 mL/min by Cockroft-Gault method. ? Normal serum calcium level ? Patients or their legal representatives must be able to read, understand and provide informed consent to participate in the trial. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: ? Patients with an active infection or with a fever > 38.50 C within 3 days of the first scheduled day of dosing ? Patients with an impending pathological fracture (erosion of at least 1/3 of the cortex by neoplastic process) ? Patients with known CNS or meningeal metastases ? Patients who have received a bisphosphonate within 3 weeks of the start of the Baseline period; however, use of bisphosphonates prior to this period IS PERMITTED ? Patients with known hypersensitivity to any of the components of ibandronic acid or zoledronic acid ? Patients with untreated esophagitis or gastric ulcers. ? Patients who are receiving concurrent investigational therapy or who have received investigational therapy within 30 days of the first scheduled day of dosing; investigational therapy is defined as treatment for which there is currently no regulatory authority approved indication. “Investigational therapy” DOES NOT refer to approved agents used in a clinical trial in an off-label manner, e.g., in a different dose or schedule, or in a non-approved tumor. ? Patients requiring systemic corticosteroid treatment in doses higher than the equivalent of 30 mg hydrocortisone per day; exceptions are topical steroids, inhalation steroids; and systemic steroids administered as prophylactic anti-emetics with chemotherapy ? Treatment with Strontium89 or Samarium153 within 6 months of baseline ? Radiotherapy to bone within 4 weeks of randomization ? Pre-scheduled or prophylactic radiotherapy to bone, whether administered for bone pain or not ? Patients with Paget’s disease of bone ? Patients who are pregnant or lactating ? Any other medical condition, including mental illness or substance abuse, deemed by the Investigator to be likely to interfere with a patient’s ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): The primary endpoint for the study is a decrease in the patient's mean pain score of at least 25% compared to their mean pain score at Baseline (based over 7- day periods using the 'worst pain' Brief Pain Inventory scale). There must be no more than a 25% increase in mean analgesic consumption over the same 7-day period compared to mean Baseline analgesic consumption, and the decrease in pain must persist for at least 6 weeks.;Main Objective: The primary objective is to compare the difference in pain responses between treatment with ibandronic acid vs. zoledronic acid in patients with malignancy and painful metastatic bone disease. In this study, pain response is defined as a: 25% decrease in mean pain score over a 7- day period compared to mean pain score at baseline, with no more than a 25% increase in mean analgesic consumption over the same 7-day period compared to mean Baseline analgesic consumption that persists for at least 6 weeks, as determined by the “WORST PAIN” scale of the Brief Pain Inventory (BPI). ;Secondary Objective: Efficacy: Duration of the Pain Response, length of time from baseline to initial pain response, opioid side effects, analgesic consumption, and several series of functional performance and quality of life assessments. Safety: A comparison of the safety and tolerance of ibandronic acid and zoledronic acid will be described based on spontaneous reporting of adverse events and the monitoring of clinical laboratory results. Skeletal related events (SREs), defined as fracture, the need for radiotherapy to bone, the need for surgery to bone or spinal cord compression, will be specifically and prospectively monitored for the 6-month duration of the trial. Pharmcokinetic Objectives: To evaluate by a population analysis approach the pharmacokinetics of ibandronate in the target patient population, including the influence of various covariates. | — |
Countries
Germany, Hungary, Italy, United Kingdom
Outcome results
None listed