Receiving Chemotherapy
 Breast Cancer Patients

Receiving Hormonal Therapy
 
Pamidronate

Disodium (PD)
 Placebo (P)
 PD vs P
 Pamidronate

Disodium (PD)
 Placebo (P)
 PD vs P
 
N
 Mean Δ
 N
 Mean Δ
 P-Value*
 N
 Mean Δ
 N
 Mean Δ
 P-Value*
 
     
Pain Score
 175
 +0.93
 183
 +1.69
 .050
 173
 +0.50
 179
 +1.60
 .007
 
Analgesic Score
 175
 +0.74
 183
 +1.55
 .009
 173
 +0.90
 179
 +2.28
 <.001
 
ECOG PS
 178
 +0.81
 186
 +1.19
 .002
 175
 +0.95
 182
 +0.90
 .773
 
Spitzer QOL
 177
 -1.76
 185
 -2.21
 .103
 173
 -1.86
 181
 -2.05
 .409
 
Decreases in pain, analgesic scores and ECOG PS, and increases in Spitzer QOL indicate an improvement from baseline.
 

INDICATIONS AND USAGE

Hypercalcemia of Malignancy
Pamidronate disodium, in conjunction with adequate hydration, is indicated for the treatment of moderate or severe hypercalcemia associated with malignancy, with or without bone metastases. Patients who have either epidermoid or non-epidermoid tumors respond to treatment with pamidronate disodium. Vigorous saline hydration, an integral part of hypercalcemia therapy, should be initiated promptly and an attempt should be made to restore the urine output to about 2 L/day throughout treatment. Mild or asymptomatic hypercalcemia may be treated with conservative measures (i.e., saline hydration, with or without loop diuretics). Patients should be hydrated adequately throughout the treatment, but overhydration, especially in those patients who have cardiac failure, must be avoided. Diuretic therapy should not be employed prior to correction of hypovolemia. The safety and efficacy of pamidronate disodium in the treatment of hypercalcemia associated with hyperparathyroidism or with other non-tumor-related conditions has not been established.

Paget’s Disease
Pamidronate disodium is indicated for the treatment of patients with moderate to severe Paget’s disease of bone. The effectiveness of pamidronate disodium was demonstrated primarily in patients with serum alkaline phosphatase ≥3 times the upper limit of normal. Pamidronate disodium therapy in patients with Paget’s disease has been effective in reducing serum alkaline phosphatase and urinary hydroxyproline levels by ≥50% in at least 50% of patients, and by ≥30% in at least 80% of patients. Pamidronate disodium therapy has also been effective in reducing these biochemical markers in patients with Paget’s disease who failed to respond, or no longer responded to other treatments.

Osteolytic Bone Metastases of Breast Cancer and Osteolytic Lesions of Multiple Myeloma