Tags

Type your tag names separated by a space and hit enter

Bone density, turnover, and estimated strength in postmenopausal women treated with odanacatib: a randomized trial.
J Clin Endocrinol Metab. 2013 Feb; 98(2):571-80.JC

Abstract

CONTEXT

Odanacatib, a cathepsin K inhibitor, increases spine and hip areal bone mineral density (BMD) in postmenopausal women with low BMD and cortical thickness in ovariectomized monkeys.

OBJECTIVE

The objective of the study was to examine the impact of odanacatib on the trabecular and cortical bone compartments and estimated strength at the hip and spine.

DESIGN

This was a randomized, double-blind, 2-year trial.

SETTING

The study was conducted at a private or institutional practice.

PARTICIPANTS

PARTICIPANTS included 214 postmenopausal women with low areal BMD.

INTERVENTION

The intervention included odanacatib 50 mg or placebo weekly.

MAIN OUTCOME MEASURES

Changes in areal BMD by dual-energy x-ray absorptiometry (primary end point, 1 year areal BMD change at lumbar spine), bone turnover markers, volumetric BMD by quantitative computed tomography (QCT), and bone strength estimated by finite element analysis were measured.

RESULTS

Year 1 lumbar spine areal BMD percent change from baseline was 3.5% greater with odanacatib than placebo (P < .001). Bone-resorption marker C-telopeptide of type 1 collagen was significantly lower with odanacatib vs placebo at 6 months and 2 years (P < .001). Bone-formation marker procollagen I N-terminal peptide initially decreased with odanacatib but by 2 years did not differ from placebo. After 6 months, odanacatib-treated women had greater increases in trabecular volumetric BMD and estimated compressive strength at the spine and integral and trabecular volumetric BMD and estimated strength at the hip (P < .001). At the cortical envelope of the femoral neck, bone mineral content, thickness, volume, and cross-sectional area also increased from baseline with odanacatib vs placebo (P < .001 at 24 months). Adverse experiences were similar between groups.

CONCLUSIONS

Over 2 years, odanacatib decreased bone resorption, maintained bone formation, increased areal and volumetric BMD, and increased estimated bone strength at both the hip and spine.

Authors+Show Affiliations

Department of Endocrinology, Institute of Clinical Research, University of Southern Denmark, DK-5000 Odense C., Denmark. kbrixen@health.sdu.dkNo 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 availableNo affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

23337728

Citation

Brixen, Kim, et al. "Bone Density, Turnover, and Estimated Strength in Postmenopausal Women Treated With Odanacatib: a Randomized Trial." The Journal of Clinical Endocrinology and Metabolism, vol. 98, no. 2, 2013, pp. 571-80.
Brixen K, Chapurlat R, Cheung AM, et al. Bone density, turnover, and estimated strength in postmenopausal women treated with odanacatib: a randomized trial. J Clin Endocrinol Metab. 2013;98(2):571-80.
Brixen, K., Chapurlat, R., Cheung, A. M., Keaveny, T. M., Fuerst, T., Engelke, K., Recker, R., Dardzinski, B., Verbruggen, N., Ather, S., Rosenberg, E., & de Papp, A. E. (2013). Bone density, turnover, and estimated strength in postmenopausal women treated with odanacatib: a randomized trial. The Journal of Clinical Endocrinology and Metabolism, 98(2), 571-80. https://doi.org/10.1210/jc.2012-2972
Brixen K, et al. Bone Density, Turnover, and Estimated Strength in Postmenopausal Women Treated With Odanacatib: a Randomized Trial. J Clin Endocrinol Metab. 2013;98(2):571-80. PubMed PMID: 23337728.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Bone density, turnover, and estimated strength in postmenopausal women treated with odanacatib: a randomized trial. AU - Brixen,Kim, AU - Chapurlat,Roland, AU - Cheung,Angela M, AU - Keaveny,Tony M, AU - Fuerst,Thomas, AU - Engelke,Klaus, AU - Recker,Robert, AU - Dardzinski,Bernard, AU - Verbruggen,Nadia, AU - Ather,Shabana, AU - Rosenberg,Elizabeth, AU - de Papp,Anne E, Y1 - 2013/01/21/ PY - 2013/1/23/entrez PY - 2013/1/23/pubmed PY - 2013/4/11/medline SP - 571 EP - 80 JF - The Journal of clinical endocrinology and metabolism JO - J Clin Endocrinol Metab VL - 98 IS - 2 N2 - CONTEXT: Odanacatib, a cathepsin K inhibitor, increases spine and hip areal bone mineral density (BMD) in postmenopausal women with low BMD and cortical thickness in ovariectomized monkeys. OBJECTIVE: The objective of the study was to examine the impact of odanacatib on the trabecular and cortical bone compartments and estimated strength at the hip and spine. DESIGN: This was a randomized, double-blind, 2-year trial. SETTING: The study was conducted at a private or institutional practice. PARTICIPANTS: PARTICIPANTS included 214 postmenopausal women with low areal BMD. INTERVENTION: The intervention included odanacatib 50 mg or placebo weekly. MAIN OUTCOME MEASURES: Changes in areal BMD by dual-energy x-ray absorptiometry (primary end point, 1 year areal BMD change at lumbar spine), bone turnover markers, volumetric BMD by quantitative computed tomography (QCT), and bone strength estimated by finite element analysis were measured. RESULTS: Year 1 lumbar spine areal BMD percent change from baseline was 3.5% greater with odanacatib than placebo (P < .001). Bone-resorption marker C-telopeptide of type 1 collagen was significantly lower with odanacatib vs placebo at 6 months and 2 years (P < .001). Bone-formation marker procollagen I N-terminal peptide initially decreased with odanacatib but by 2 years did not differ from placebo. After 6 months, odanacatib-treated women had greater increases in trabecular volumetric BMD and estimated compressive strength at the spine and integral and trabecular volumetric BMD and estimated strength at the hip (P < .001). At the cortical envelope of the femoral neck, bone mineral content, thickness, volume, and cross-sectional area also increased from baseline with odanacatib vs placebo (P < .001 at 24 months). Adverse experiences were similar between groups. CONCLUSIONS: Over 2 years, odanacatib decreased bone resorption, maintained bone formation, increased areal and volumetric BMD, and increased estimated bone strength at both the hip and spine. SN - 1945-7197 UR - https://www.unboundmedicine.com/medline/citation/23337728/Bone_density_turnover_and_estimated_strength_in_postmenopausal_women_treated_with_odanacatib:_a_randomized_trial_ L2 - https://academic.oup.com/jcem/article-lookup/doi/10.1210/jc.2012-2972 DB - PRIME DP - Unbound Medicine ER -