None listed
Conditions
Interventions
Group 1: Pamidronate disodium Type of group
Disodium pamidronate 90mg by IV infusion for 2 hours, every 3 weeks, for 9 doses.
Group name:Placebo Type of group
Placebo of Pamidronate by IV infusion of 2 hours, every 3 weeks, for 9 doses.
Sponsors
NOVARTIS BIOSCIENSES PERÚ S.A.,
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male patients over 18 who have signed informed consent. 2. Confirmed diagnosis of prostate cancer in phase D2 with at least 01 bone metastases. 3. Failure of 1st line therapy or more (documented). 4. Life expectancy of at least 6 months. 6. Presence of bone pain secondary to bone metastases.
Exclusion criteria
Exclusion criteria: 1. Abnormal laboratory values: WBC≤3.0x109 / L; Platelets Rct 2.5mg / dL. 2. Untreated brain metastases. 3. Previous treatment with more than 03 doses of a bisphosphonate or during the 90 days prior to V2. 4. Previous history of allergic reaction or sensitivity to bisphosphonates. 5. Use of other investigational drugs during the 30 days prior to V2. 6. Change in the endocrine or chemotherapy treatment regimen during the 6 weeks prior to V2. 7. History of non-compliance with medical regimens and patients that are considered potentially unreliable. 8. ECG with significant abnormalities. 9. Ascistis. 10. Patients who have experienced an event related to the Skeleton (pathological fracture, bone radiation, bone surgery, spinal orthosis or compression of the ME) in the month prior to V2. 11. Orthopedic surgery or radiation therapy (including radiotherapy) to correct or treat defects related to metastatic bone lesions. 12. Compression of imminent ME.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Brief pain inventory scale (BPI) self-evaluated by the patient. Measure:Difference in the score of the worst pain during visits 2 to 5. Timepoints:9 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Brief pain inventory scale (BPI) self-evaluated by the patient. Measure:Change in the BPI score from V2 to VF (final visit) Timepoints:9 weeks ; Outcome name:SMR, defined as the ratio of number of episodes related to the skeleton (SRE) divided by the trial period. Measure:Skeletal morbidity rate (SMR) Timepoints:9 and 27 weeks ; Outcome name:Percentage of patients with SRE and time to the first SRE. Measure:Percentage of patients presenting some SRE and time elapsed until the first SRE. Timepoints:27 weeks | — |
Outcome results
None listed