Aredia

Clinical Pharmacology

font size

Clinical Pharmacology

Aredia

Two double-blind, randomized, placebo-controlled trials compared the safety and efficacy of 90 mg of Aredia infused over 2 hours every 3 to 4 weeks for 24 months to that of placebo in preventing SREs in breast cancer patients with osteolytic bone metastases who had one or more predominantly lytic metastases of at least 1 cm in diameter: one in patients being treated with antineoplastic chemotherapy and the second in patients being treated with hormonal antineoplastic therapy at trial entry.

382 patients receiving chemotherapy were randomized, 185 to Aredia and 197 to placebo. 372 patients receiving hormonal therapy were randomized, 182 to Aredia and 190 to placebo. All but three patients were evaluable for efficacy. Patients were followed for 24 months of therapy or until they went off study. Median duration of follow-up was 13 months in patients receiving chemotherapy and 17 months in patients receiving hormone therapy. Twenty-five percent of the patients in the chemotherapy study and 37% of the patients in the hormone therapy study received Aredia for 24 months. The efficacy results are shown in the table below:

	Breast Cancer Patients Receiving Chemotherapy						Breast Cancer Patients Receiving Hormonal Therapy
	Any SRE		Radiation		Fractures		Any SRE		Radiation		Fractures
	A	P	A	P	A	P	A	P	A	P	A	P
N	185	195	185	195	185	195	182	189	182	189	182	189
Skeletal Morbidity Rate (#SRE/year) Mean	2.5	3.7	0.8	1.3	1.6	2.2	2.4	3.6	0.6	1.2	1.6	2.2
P-Value	< .001		< .001^†		.018^†		.021		.013^†		.040^†
Proportion of patients having an SRE	46%	65%	28%	45%	36%	49%	55%	63%	31%	40%	45%	55%
P-Value	< .001		< .001^†		.014^†		.094		.058^†		.054^†
Median Time to SRE (months)	13.9	7.0	NR**	14.2	25.8	13.3	10.9	7.4	NR**	23.4	20.6	12.8
P-Value	< .001		< .001^†		.009^†		.118		.016^†		.113^†
^†Fractures and radiation to bone were two of several secondary endpoints. The statistical significance of these analyses may be overestimated since numerous analyses were performed. **NR = Not Reached.