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Changes in bone mineral density, bone turnover markers, and vertebral fracture risk reduction with once weekly teriparatide.
Curr Med Res Opin. 2014 May; 30(5):931-6.CM

Abstract

OBJECTIVE

We aimed to evaluate the surrogacy of bone mineral density and bone turnover markers for incident vertebral fracture using data from 237 patients treated with once weekly 56.5 μg teriparatide or placebo.

METHODS

This analysis was conducted using data from the Teriparatide Once-Weekly Efficacy Research trial, a randomized, double-blind, placebo-controlled trial for patients with severe osteoporosis in Japan. A total of 237 subjects (placebo group, n = 130; teriparatide group, n = 107) were assessed at baseline and at 72 weeks. Main outcome measures included estimation of the treatment effects of once weekly teriparatide on vertebral fracture risk reduction using percentage changes in lumbar bone mineral density and bone turnover markers.

RESULTS

The percentage change in lumbar bone mineral density was 6.69% in the teriparatide group compared with 0.28% in the placebo group (p < 0.01). One incident vertebral fracture occurred in the teriparatide group compared with 16 in the placebo group. The unadjusted and adjusted hazard ratios of the teriparatide group compared with the placebo group were 0.07 (95% confidence interval: 0.01 to 0.56) and 0.64 (95% confidence interval: 0.06 to 6.36), respectively. The proportion of treatment effect explained by changes in lumbar bone mineral density was 83% (Freedman's method) and 66% (Chen's method). There were no notable changes in hazard ratios if we adjusted for bone turnover markers.

CONCLUSIONS

Most of the vertebral fracture risk reduction with once weekly 56.5 μg teriparatide is explained by changes in lumbar bone mineral density rather than changes in bone turnover markers.

Authors+Show Affiliations

Graduate School of Medicine and Public Health, Kyoto University , Kyoto , Japan.No 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

24392946

Citation

Tanaka, Shiro, et al. "Changes in Bone Mineral Density, Bone Turnover Markers, and Vertebral Fracture Risk Reduction With once Weekly Teriparatide." Current Medical Research and Opinion, vol. 30, no. 5, 2014, pp. 931-6.
Tanaka S, Kuroda T, Sugimoto T, et al. Changes in bone mineral density, bone turnover markers, and vertebral fracture risk reduction with once weekly teriparatide. Curr Med Res Opin. 2014;30(5):931-6.
Tanaka, S., Kuroda, T., Sugimoto, T., Nakamura, T., & Shiraki, M. (2014). Changes in bone mineral density, bone turnover markers, and vertebral fracture risk reduction with once weekly teriparatide. Current Medical Research and Opinion, 30(5), 931-6. https://doi.org/10.1185/03007995.2013.879440
Tanaka S, et al. Changes in Bone Mineral Density, Bone Turnover Markers, and Vertebral Fracture Risk Reduction With once Weekly Teriparatide. Curr Med Res Opin. 2014;30(5):931-6. PubMed PMID: 24392946.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Changes in bone mineral density, bone turnover markers, and vertebral fracture risk reduction with once weekly teriparatide. AU - Tanaka,Shiro, AU - Kuroda,Tatsuhiko, AU - Sugimoto,Toshitsugu, AU - Nakamura,Toshitaka, AU - Shiraki,Masataka, Y1 - 2014/01/13/ PY - 2014/1/8/entrez PY - 2014/1/8/pubmed PY - 2014/10/29/medline SP - 931 EP - 6 JF - Current medical research and opinion JO - Curr Med Res Opin VL - 30 IS - 5 N2 - OBJECTIVE: We aimed to evaluate the surrogacy of bone mineral density and bone turnover markers for incident vertebral fracture using data from 237 patients treated with once weekly 56.5 μg teriparatide or placebo. METHODS: This analysis was conducted using data from the Teriparatide Once-Weekly Efficacy Research trial, a randomized, double-blind, placebo-controlled trial for patients with severe osteoporosis in Japan. A total of 237 subjects (placebo group, n = 130; teriparatide group, n = 107) were assessed at baseline and at 72 weeks. Main outcome measures included estimation of the treatment effects of once weekly teriparatide on vertebral fracture risk reduction using percentage changes in lumbar bone mineral density and bone turnover markers. RESULTS: The percentage change in lumbar bone mineral density was 6.69% in the teriparatide group compared with 0.28% in the placebo group (p < 0.01). One incident vertebral fracture occurred in the teriparatide group compared with 16 in the placebo group. The unadjusted and adjusted hazard ratios of the teriparatide group compared with the placebo group were 0.07 (95% confidence interval: 0.01 to 0.56) and 0.64 (95% confidence interval: 0.06 to 6.36), respectively. The proportion of treatment effect explained by changes in lumbar bone mineral density was 83% (Freedman's method) and 66% (Chen's method). There were no notable changes in hazard ratios if we adjusted for bone turnover markers. CONCLUSIONS: Most of the vertebral fracture risk reduction with once weekly 56.5 μg teriparatide is explained by changes in lumbar bone mineral density rather than changes in bone turnover markers. SN - 1473-4877 UR - https://www.unboundmedicine.com/medline/citation/24392946/Changes_in_bone_mineral_density_bone_turnover_markers_and_vertebral_fracture_risk_reduction_with_once_weekly_teriparatide_ L2 - https://www.tandfonline.com/doi/full/10.1185/03007995.2013.879440 DB - PRIME DP - Unbound Medicine ER -