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Differential Effects of Teriparatide and Zoledronic Acid on Bone Mineralization Density Distribution at 6 and 24 Months in the SHOTZ Study.
J Bone Miner Res. 2016 08; 31(8):1527-35.JB

Abstract

The Skeletal Histomorphometry in Patients on Teriparatide or Zoledronic Acid Therapy (SHOTZ) study assessed the progressive effects of teriparatide (TPTD) and zoledronic acid (ZOL) on bone remodeling and material properties in postmenopausal women with osteoporosis. Previously, we reported that biochemical and histomorphometric bone formation indices were significantly higher in patients receiving TPTD versus ZOL. Here we report bone mineralization density distribution (BMDD) results based on quantitative backscattered electron imaging (qBEI). The 12-month primary study was randomized and double blind until the month 6 biopsy, then open label. Patients (TPTD, n = 28; ZOL, n = 31) were then eligible to enter a 12-month open-label extension with their original treatment: TPTD 20 μg/d (subcutaneous injection) or ZOL 5 mg/yr (intravenous infusion). A second biopsy was collected from the contralateral side at month 24 (TPTD, n = 10; ZOL, n = 10). In cancellous bone, ZOL treatment was associated at 6 and 24 months with significantly higher average degree of mineralization (CaMEAN, +2.2%, p = 0.018; +3.9%, p = 0.009, respectively) and with lower percentage of low mineralized areas (CaLOW , -34.6%, p = 0.029; -33.7%, p = 0.025, respectively) and heterogeneity of mineralization CaWIDTH (-12.3%, p = 0.003; -9.9%, p = 0.012, respectively), indicating higher mineralization density and more homogeneous mineral content versus TPTD. Within the ZOL group, significant changes were found in all parameters from month 6 to 24, indicating a progressive increase in mineralization density. In sharp contrast, mineralization density did not increase over time with TPTD, reflecting ongoing deposition of new bone. Similar results were observed in cortical bone. In this study, TPTD stimulated new bone formation, producing a mineralized bone matrix that remained relatively heterogeneous with a stable mean mineral content. ZOL slowed bone turnover and prolonged secondary mineralization, producing a progressively more homogeneous and highly mineralized bone matrix. Although both TPTD and ZOL increase clinical measures of bone mineral density (BMD), this study shows that the underlying mechanisms of the BMD increases are fundamentally different. © 2016 American Society for Bone and Mineral Research.

Authors+Show Affiliations

Regional Bone Center, Helen Hayes Hospital, West Haverstraw, NY, USA. Department of Pathology and Cell Biology, College of Physicians and Surgeons, Columbia University, New York, NY, USA.Ludwig Boltzmann Institute of Osteology, Hanusch Hospital of WGKK and AUVA Trauma Center Meidling, 1st Med. Dept. Hanusch Hospital, Vienna, Austria.Ludwig Boltzmann Institute of Osteology, Hanusch Hospital of WGKK and AUVA Trauma Center Meidling, 1st Med. Dept. Hanusch Hospital, Vienna, Austria.Regional Bone Center, Helen Hayes Hospital, West Haverstraw, NY, USA.Ludwig Boltzmann Institute of Osteology, Hanusch Hospital of WGKK and AUVA Trauma Center Meidling, 1st Med. Dept. Hanusch Hospital, Vienna, Austria.Lilly USA, LLC, Indianapolis, IN, USA.Lilly USA, LLC, Indianapolis, IN, USA.Ludwig Boltzmann Institute of Osteology, Hanusch Hospital of WGKK and AUVA Trauma Center Meidling, 1st Med. Dept. Hanusch Hospital, Vienna, Austria.Lilly USA, LLC, Indianapolis, IN, USA.

Pub Type(s)

Clinical Trial, Phase IV
Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

26931279

Citation

Dempster, David W., et al. "Differential Effects of Teriparatide and Zoledronic Acid On Bone Mineralization Density Distribution at 6 and 24 Months in the SHOTZ Study." Journal of Bone and Mineral Research : the Official Journal of the American Society for Bone and Mineral Research, vol. 31, no. 8, 2016, pp. 1527-35.
Dempster DW, Roschger P, Misof BM, et al. Differential Effects of Teriparatide and Zoledronic Acid on Bone Mineralization Density Distribution at 6 and 24 Months in the SHOTZ Study. J Bone Miner Res. 2016;31(8):1527-35.
Dempster, D. W., Roschger, P., Misof, B. M., Zhou, H., Paschalis, E. P., Alam, J., Ruff, V. A., Klaushofer, K., & Taylor, K. A. (2016). Differential Effects of Teriparatide and Zoledronic Acid on Bone Mineralization Density Distribution at 6 and 24 Months in the SHOTZ Study. Journal of Bone and Mineral Research : the Official Journal of the American Society for Bone and Mineral Research, 31(8), 1527-35. https://doi.org/10.1002/jbmr.2825
Dempster DW, et al. Differential Effects of Teriparatide and Zoledronic Acid On Bone Mineralization Density Distribution at 6 and 24 Months in the SHOTZ Study. J Bone Miner Res. 2016;31(8):1527-35. PubMed PMID: 26931279.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Differential Effects of Teriparatide and Zoledronic Acid on Bone Mineralization Density Distribution at 6 and 24 Months in the SHOTZ Study. AU - Dempster,David W, AU - Roschger,Paul, AU - Misof,Barbara M, AU - Zhou,Hua, AU - Paschalis,Eleftherios P, AU - Alam,Jahangir, AU - Ruff,Valerie A, AU - Klaushofer,Klaus, AU - Taylor,Kathleen A, Y1 - 2016/03/30/ PY - 2015/12/21/received PY - 2016/02/18/revised PY - 2016/02/26/accepted PY - 2016/3/3/entrez PY - 2016/3/5/pubmed PY - 2017/12/19/medline KW - ANABOLICS KW - ANTIRESPORPTIVES KW - CLINICAL TRIALS KW - MATRIX MINERALIZATION KW - OSTEOPOROSIS SP - 1527 EP - 35 JF - Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research JO - J Bone Miner Res VL - 31 IS - 8 N2 - The Skeletal Histomorphometry in Patients on Teriparatide or Zoledronic Acid Therapy (SHOTZ) study assessed the progressive effects of teriparatide (TPTD) and zoledronic acid (ZOL) on bone remodeling and material properties in postmenopausal women with osteoporosis. Previously, we reported that biochemical and histomorphometric bone formation indices were significantly higher in patients receiving TPTD versus ZOL. Here we report bone mineralization density distribution (BMDD) results based on quantitative backscattered electron imaging (qBEI). The 12-month primary study was randomized and double blind until the month 6 biopsy, then open label. Patients (TPTD, n = 28; ZOL, n = 31) were then eligible to enter a 12-month open-label extension with their original treatment: TPTD 20 μg/d (subcutaneous injection) or ZOL 5 mg/yr (intravenous infusion). A second biopsy was collected from the contralateral side at month 24 (TPTD, n = 10; ZOL, n = 10). In cancellous bone, ZOL treatment was associated at 6 and 24 months with significantly higher average degree of mineralization (CaMEAN, +2.2%, p = 0.018; +3.9%, p = 0.009, respectively) and with lower percentage of low mineralized areas (CaLOW , -34.6%, p = 0.029; -33.7%, p = 0.025, respectively) and heterogeneity of mineralization CaWIDTH (-12.3%, p = 0.003; -9.9%, p = 0.012, respectively), indicating higher mineralization density and more homogeneous mineral content versus TPTD. Within the ZOL group, significant changes were found in all parameters from month 6 to 24, indicating a progressive increase in mineralization density. In sharp contrast, mineralization density did not increase over time with TPTD, reflecting ongoing deposition of new bone. Similar results were observed in cortical bone. In this study, TPTD stimulated new bone formation, producing a mineralized bone matrix that remained relatively heterogeneous with a stable mean mineral content. ZOL slowed bone turnover and prolonged secondary mineralization, producing a progressively more homogeneous and highly mineralized bone matrix. Although both TPTD and ZOL increase clinical measures of bone mineral density (BMD), this study shows that the underlying mechanisms of the BMD increases are fundamentally different. © 2016 American Society for Bone and Mineral Research. SN - 1523-4681 UR - https://www.unboundmedicine.com/medline/citation/26931279/Differential_Effects_of_Teriparatide_and_Zoledronic_Acid_on_Bone_Mineralization_Density_Distribution_at_6_and_24_Months_in_the_SHOTZ_Study_ L2 - https://doi.org/10.1002/jbmr.2825 DB - PRIME DP - Unbound Medicine ER -