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J Clin Endocrinol Metab. 2013 Dec;98(12):4727-35. doi: 10.1210/jc.2013-2020. Epub 2013 Sep 24.

Effects of odanacatib on BMD and safety in the treatment of osteoporosis in postmenopausal women previously treated with alendronate: a randomized placebo-controlled trial.

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1
MD, PhD, 126 East Lincoln Avenue, Rahway, NJ 07065-0900. deborah.gurner@merck.com.

Abstract

CONTEXT:

Odanacatib (ODN) is a selective cathepsin K inhibitor being developed to treat osteoporosis.

OBJECTIVE:

The effects of ODN were evaluated on bone mineral density (BMD), biochemical markers of bone turnover, and safety in patients previously treated with alendronate.

DESIGN:

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

SETTING:

The study was conducted at private or institutional practices.

PARTICIPANTS:

Postmenopausal women (n = 243) ≥ 60 years of age with low BMD at the total hip, femoral neck, or trochanter (T-score ≤-2.5 but >-3.5 without prior fracture or ≤-1.5 but >-3.5 with prior fracture) on alendronate for ≥ 3 years.

INTERVENTION:

The intervention included ODN 50 mg or placebo weekly.

MAIN OUTCOME MEASURES:

The primary end point was percentage change from baseline of femoral neck BMD at month 24. BMD was assessed by dual-energy x-ray absorptiometry at baseline and 6, 12, and 24 months. Biochemical markers of bone turnover (serum C-telopeptides of type 1 collagen, urinary N-telopeptides of type 1 collagen, serum bone specific alkaline phosphatase, and serum N-terminal propeptide of type 1 collagen) were measured at baseline and 3, 6, 12, 18, and 24 months.

RESULTS:

In the ODN group, BMD changes from baseline at the femoral neck, trochanter, total hip, and lumbar spine at 24 months (1.7%, 1.8%, 0.8%, and 2.3%, respectively) were significantly different from the placebo group. ODN significantly decreased urinary N-telopeptides of type 1 collagen to creatinine ratio and significantly increased serum N-terminal propeptide of type 1 collagen compared with placebo. Serum C-telopeptides of type 1 collagen was unexpectedly increased with ODN treatment. The safety profile appeared similar between groups.

CONCLUSIONS:

ODN provided incremental BMD gains in osteoporotic women after alendronate treatment.

PMID:
24064689
DOI:
10.1210/jc.2013-2020
[Indexed for MEDLINE]
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