New Drug Update 2010-2011 Faculty Disclaimer - CME Conferences

2 nd Annual Essentials in Primary Care
Fall Conference
Friday, November 11, 2011
FREEDOM Trial 5 Year Data
• May 2, 2011 (San Diego, California) — Results from the first 2 years of the
international multicenter (FREEDOM) trial 10 year extension, in 4550
postmenopausal women with osteoporosis, showed that the drug
maintains its efficacy in improving bone mineral density (BMD) and
reducing the incidence of fractures over 5 years without any increase in
adverse events, according to researchers here at the American Association
of Clinical Endocrinologists 20th Annual Meeting and Clinical Congress.
– In the fourth and fifth year of denosumab treatment, those in the original intervention
group (2342 women) experienced further benefits in BMD of the lumbar spine and hip.
In the fourth year, BMD of the lumbar spine increased by 1.9% in the long-term
treatment group and BMD of the hip increased by 0.7%. In the fifth year of treatment,
BMD of the lumbar spine increased by 1.7% in the long-term treatment group and BMD
of the total hip increased by 0.6%.
– The de novo group (2207 women) in the extension trial experienced improvements in
BMD similar to those seen in the intervention group in the first 2 years of the original
FREEDOM trial. In the first 2 years of their treatment, the crossover group experienced a
7.9% increase in lumbar spine BMD and a 4.1% increase in total hip BMD (P < .0001,
compared with baseline).
FREEDOM Trial 5 Year Data
• The yearly incidence of new vertebral fractures was 1.4% in
the long-term denosumab group and 0.9% in the crossover
group. Rates of new nonvertebral fractures were also low,
with a yearly incidence of 1.4% in the fourth year and 1.1% in
the fifth year for the long-term treatment group. In contrast,
the yearly incidence rate of new nonvertebral fractures in the
crossover group was 2.4% in the first year of treatment and
1.7% in the second year of treatment
• The incidence of serious adverse events were low, with just 2
cases of osteonecrosis of the jaw and 1 case of cellulitis in the
crossover group of the extension trial. Three subjects in the
long-term treatment group experienced cellulitis.
Wayne Weart
New Drug Update Part I