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Effects of odanacatib on BMD and safety in the treatment of osteoporosis in postmenopausal women previously treated with alendronate: a randomized placebo-controlled trial.
J Clin Endocrinol Metab 2013; 98(12):4727-35JC

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.

Authors+Show Affiliations

MD, PhD, 126 East Lincoln Avenue, Rahway, NJ 07065-0900. deborah.gurner@merck.com.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

24064689

Citation

Bonnick, Sydney, et al. "Effects of Odanacatib On BMD and Safety in the Treatment of Osteoporosis in Postmenopausal Women Previously Treated With Alendronate: a Randomized Placebo-controlled Trial." The Journal of Clinical Endocrinology and Metabolism, vol. 98, no. 12, 2013, pp. 4727-35.
Bonnick S, De Villiers T, Odio A, et al. Effects of odanacatib on BMD and safety in the treatment of osteoporosis in postmenopausal women previously treated with alendronate: a randomized placebo-controlled trial. J Clin Endocrinol Metab. 2013;98(12):4727-35.
Bonnick, S., De Villiers, T., Odio, A., Palacios, S., Chapurlat, R., DaSilva, C., ... Gurner, D. (2013). Effects of odanacatib on BMD and safety in the treatment of osteoporosis in postmenopausal women previously treated with alendronate: a randomized placebo-controlled trial. The Journal of Clinical Endocrinology and Metabolism, 98(12), pp. 4727-35. doi:10.1210/jc.2013-2020.
Bonnick S, et al. Effects of Odanacatib On BMD and Safety in the Treatment of Osteoporosis in Postmenopausal Women Previously Treated With Alendronate: a Randomized Placebo-controlled Trial. J Clin Endocrinol Metab. 2013;98(12):4727-35. PubMed PMID: 24064689.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Effects of odanacatib on BMD and safety in the treatment of osteoporosis in postmenopausal women previously treated with alendronate: a randomized placebo-controlled trial. AU - Bonnick,Sydney, AU - De Villiers,Tobias, AU - Odio,Alberto, AU - Palacios,Santiago, AU - Chapurlat,Roland, AU - DaSilva,Carolyn, AU - Scott,Boyd B, AU - Le Bailly De Tilleghem,Celine, AU - Leung,Albert T, AU - Gurner,Deborah, Y1 - 2013/09/24/ PY - 2013/9/26/entrez PY - 2013/9/26/pubmed PY - 2014/4/15/medline SP - 4727 EP - 35 JF - The Journal of clinical endocrinology and metabolism JO - J. Clin. Endocrinol. Metab. VL - 98 IS - 12 N2 - 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. SN - 1945-7197 UR - https://www.unboundmedicine.com/medline/citation/24064689/Effects_of_odanacatib_on_BMD_and_safety_in_the_treatment_of_osteoporosis_in_postmenopausal_women_previously_treated_with_alendronate:_a_randomized_placebo_controlled_trial_ L2 - https://academic.oup.com/jcem/article-lookup/doi/10.1210/jc.2013-2020 DB - PRIME DP - Unbound Medicine ER -