This Article Full Text Full Text (PDF) All Versions of this Article: 90/7/3970    most recent Author Manuscript (PDF) Submit a related Letter to the Editor Purchase Article View Shopping Cart Alert me when this article is cited Alert me when eLetters are posted Alert me if a correction is posted Citation Map Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Request Copyright Permission Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Dobnig, H. Articles by Eriksen, E. F. Search for Related Content PubMed PubMed Citation Articles by Dobnig, H. Articles by Eriksen, E. F. Related Collections Calcium and Bone Metabolism Female Endocrinology

Early Changes in Biochemical Markers of Bone Formation Correlate with Improvements in Bone Structure during Teriparatide Therapy

Department of Internal Medicine (H.D., A.F.-P.), Medical University of Graz, A-8036 Graz, Austria; Lilly Research Laboratories (A.S., I.P., J.W., E.F.E.), Eli Lilly and Company, Indianapolis, Indiana 46285; Osteoporosis and Arthritis Research Group (Y.J.), Department of Radiology, University of California, San Francisco, California 94143; Centre Hospitalier de l’Universite de Montreal Hospital St-Luc (L.-G.S.-M.), Montreal, Quebec, H2X 1P1, Canada; and Bone Metabolism Unit (J.C.G.), Creighton University, Omaha, Nebraska 68178

Address correspondence to: Harald Dobnig, M.D., Department of Internal Medicine, Division of Endocrinology, Medical University, Auenbruggerplatz 15, A-8036 Graz, Austria. E-mail: harald.dobnig{at}meduni-graz.at. Address requests for reprints to: Adrien A. Sipos, M.D., Ph.D., Lilly Research Laboratories, DC 6134, Eli Lilly and Company, Indianapolis, Indiana 46285.

Context: Biochemical markers of bone turnover may reflect bone structure during anabolic treatment.

Objective: The objective was to evaluate associations between changes in biochemical markers and structural and dynamic bone parameters during teriparatide treatment.

Design: This study was a randomized, multicenter, double-blind, placebo-controlled fracture prevention trial, with 20-month median treatment duration for biopsy subset.

Setting: The trial was conducted at 11 clinical study sites.

Patients: Sixty-one postmenopausal women with osteoporosis who had paired transiliac biopsy specimens participated in the study.

Interventions: Once-daily sc injections of either placebo or teriparatide (20 or 40 µg) were administered.

Main outcome measures: The study measured: 1) serum and urinary biochemical markers of bone formation [bone alkaline phosphatase and procollagen I C-terminal propeptide (PICP)] and resorption (N-telopeptide and deoxypyridinoline); and 2) structural and dynamic analyses of bone biopsies, including two-dimensional (2D) histomorphometry and three-dimensional (3D) micro-computed tomography evaluations measured at baseline (n = 57) and 12 (n = 21) or 22 (n = 36) months.

Results: U-N-telopeptide/creatinine and serum-PICP correlated with bone structure and dynamic indices at baseline, respectively. Changes in bone alkaline phosphatase at 1 month correlated with changes at 22 months in 2D wall thickness (r = 0.73; P = 0.001), trabecular bone volume (trabecular bone volume per total volume, BV/TV) (r = 0.58; P < 0.05), marrow star volume (r = –0.51; P = 0.05); 3D trabecular thickness (r = 0.49; P < 0.05), and BV/TV (r = 0.54; P < 0.05). Changes in PICP at 1 month correlated with changes in wall thickness (r = 0.60; P = 0.01), and 2D BV/TV (r = 0.51; P < 0.05) at 22 months. Changes in markers at 6 or 12 months were not associated with changes in structural or dynamic parameters.

Conclusions: Early (1-month) changes in biochemical markers of bone formation, but not resorption, correlated with improvements in bone structure after 22 months of teriparatide therapy.

This article has been cited by other articles:

				A. D Anastasilakis, D. G Goulis, S. A Polyzos, S. Gerou, V. Pavlidou, G. Koukoulis, and A. Avramidis Acute changes in serum osteoprotegerin and receptor activator for nuclear factor-{kappa}B ligand levels in women with established osteoporosis treated with teriparatide Eur. J. Endocrinol., March 1, 2008; 158(3): 411 - 415. [Abstract] [Full Text] [PDF]

				S. L. Greenspan, H. G. Bone, M. P. Ettinger, D. A. Hanley, R. Lindsay, J. R. Zanchetta, C. M. Blosch, A. L. Mathisen, S. A. Morris, T. B. Marriott, et al. Effect of Recombinant Human Parathyroid Hormone (1-84) on Vertebral Fracture and Bone Mineral Density in Postmenopausal Women with Osteoporosis: A Randomized Trial Ann Intern Med, March 6, 2007; 146(5): 326 - 339. [Abstract] [Full Text] [PDF]