New Drug Update 2010-2011 Faculty Disclaimer - CME Conferences

2 nd Annual Essentials in Primary Care
Fall Conference
Friday, November 11, 2011
Risedronate - Atelvia
• The efficacy of Atelvia 35 mg once-a-week in the
treatment of postmenopausal osteoporosis was
demonstrated in a randomized, double-blind, activecontrol
trial of approximately 900 subjects.
• All patients in this study received supplemental
calcium (1000 mg/day) and vitamin D (800 – 1000
IU/day).
• The primary efficacy endpoint was percent change in
lumbar spine bone mineral density at 1 year.
• Atelvia 35 mg once-a -week administered after
breakfast was shown to be non-inferior to
risedronate sodium immediate-release 5 mg daily
(3.3% vs. 3.1% increase in lumbar spine BMD)
Risedronate - Atelvia
HIP Trial (NEJM 2001;344:333-340)
• 5445 women 70 to 79 years old who had osteoporosis
(indicated by a T score for BMD at the femoral neck that was
more than 4 SD below the mean peak value in young adults
or lower than -3 plus a nonskeletal risk factor for hip
fracture, such as poor gait or a propensity to fall) and 3886
women at least 80 years old who had at least one
nonskeletal risk factor for hip fracture or low bone mineral
density at the femoral neck (T score, lower than -4
• Patients were randomly assigned to receive treatment with
oral risedronate (2.5 or 5.0 mg daily) or placebo for three
years.
• The primary end point was the occurrence of hip fracture.
Wayne Weart
New Drug Update Part I