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Amgen Bone Health Mentoring Program

Monday, October 15, at 11:30am – 2:30pm ◼ Ruth Chris, Minneapolis, MN

1027: Effects of Odanacatib on BMD and Overall Safety in the

Treatment of Osteoporosis in Postmenopausal Women

Previously Treated with Alendronate

De Villiers T, Bonnick S, Odio A et al.

Session: Concurrent Oral Session 05: John H. Carsten's
Memorial Session for Osteoporosis Treatment ◼ Saturday,
October 13, 10:00 AM - 10:15 AM ◼ Room Location: Auditorium-

Main/Minneapolis Convention Center

Background Abstract Information Additional Notes
/Objectives from
▪ ODN, a potent, orally-active cathepsin K
Methods inhibitor for management of PMO is under Poster/Presentation*
development.
Strengths,
▪ The purpose of this study was to evaluate Weaknesses, Key
the effect outcome of ODN 50 mg once Points
weekly on BMD levels and biochemical
bone markers in patients previously
treated with ALN for over 3 years.

▪ It was a randomized, double-blind,
placebo-controlled, 24-month study.

▪ Primary end point of the study was percent
change in FN BMD.

▪ A total of 243 postmenopausal women
aged ≥60 years with BMD T-score in the
range ≤–2.5 but >-3.5, no past history of
fracture and history of ALN therapy for ≥3
years were recruited into the study

▪ Patients either received ODN 50 mg once
weekly or placebo for 24 months

▪ BMD levels were recorded at 6, 12 and 24
months and biochemical marker of bone
turnover were assessed at baseline, 3, 6,
12, 18 and 24 months.

▪ Safety and tolerability of ODN was also
evaluated.

* Assignment notes will be collected at the Amgen Mentoring Program Debrief Meeting. Hardcopy or Electronic versions are acceptable