Pouneh K Fazeli1, Irene S Wang, Karen K Miller, David B Herzog, Madhusmita Misra, Hang Lee, Joel S Finkelstein, Mary L Bouxsein, Anne Klibanski. 1. Neuroendocrine Unit (P.K.F., I.S.W., K.K.M., M.M., A.K.), Biostatistics Center (H.L.), and Endocrine Unit (J.S.F.), Massachusetts General Hospital, Boston, Massachusetts 02114; Center for Advanced Orthopaedic Studies (M.L.B.), Beth Israel Deaconess Medical Center, Boston, Massachusetts 02215; and Harvard Medical School (P.K.F., K.K.M., D.B.H., M.M., H.L., J.S.F., M.L.B., A.K.), Boston, Massachusetts 02115.
Abstract
CONTEXT: Anorexia nervosa (AN), a prevalent psychiatric disorder predominantly affecting women, is characterized by self-induced starvation and low body weight. Increased clinical fractures are common, and most women have low bone mineral density (BMD). Previously investigated treatments have led to no or modest increases in BMD in AN. OBJECTIVE: Our objective was to investigate the effect of teriparatide (TPT; human PTH[1-34]), an anabolic agent, on low bone mass in women with AN. DESIGN, SETTING, AND PATIENTS: This randomized, placebo-controlled trial at a clinical research center included 21 women with AN: 10 (mean age ± SEM, 47 ± 2.7 years) treated with TPT and 11 (47.1 ± 2.3 years) treated withplacebo. INTERVENTIONS:TPT (20 μg s.c.) or placebo was administered for 6 months. MAIN OUTCOME MEASURES: Our primary outcome measure was change in BMD of the spine and hip by dual-energy x-ray absorptiometry. Secondary outcome measures included changes in serum N-terminal propeptide of type 1 procollagen (P1NP), C-terminal collagen cross-links, sclerostin, and IGF-1 levels. RESULTS: At 6 months, spine BMD increased significantly more with TPT (posteroanterior spine, 6.0% ± 1.4%; lateral spine, 10.5% ± 2.5%) compared with placebo (posteroanterior spine, 0.2% ± 0.7%, P < .01; lateral spine, -0.6% ± 1.0%; P < .01). The results remained significant after controlling for baseline body mass index, P1NP, and IGF-1. Changes in femoral neck (P = .4) and total hip (P = 0.8) BMD were comparable in both groups, as were changes in weight. Serum P1NP levels increased after 3 months of TPT treatment and remained at this higher level at 6 months, whereas P1NP levels were unchanged in the placebo group (P = .02). TPT was well-tolerated by all subjects. CONCLUSIONS: This study demonstrates that TPT administration increases spine BMD substantially after only 6 months of therapy in women with AN.
RCT Entities:
CONTEXT: Anorexia nervosa (AN), a prevalent psychiatric disorder predominantly affecting women, is characterized by self-induced starvation and low body weight. Increased clinical fractures are common, and most women have low bone mineral density (BMD). Previously investigated treatments have led to no or modest increases in BMD in AN. OBJECTIVE: Our objective was to investigate the effect of teriparatide (TPT; humanPTH[1-34]), an anabolic agent, on low bone mass in women with AN. DESIGN, SETTING, AND PATIENTS: This randomized, placebo-controlled trial at a clinical research center included 21 women with AN: 10 (mean age ± SEM, 47 ± 2.7 years) treated with TPT and 11 (47.1 ± 2.3 years) treated with placebo. INTERVENTIONS:TPT (20 μg s.c.) or placebo was administered for 6 months. MAIN OUTCOME MEASURES: Our primary outcome measure was change in BMD of the spine and hip by dual-energy x-ray absorptiometry. Secondary outcome measures included changes in serum N-terminal propeptide of type 1 procollagen (P1NP), C-terminal collagen cross-links, sclerostin, and IGF-1 levels. RESULTS: At 6 months, spine BMD increased significantly more with TPT (posteroanterior spine, 6.0% ± 1.4%; lateral spine, 10.5% ± 2.5%) compared with placebo (posteroanterior spine, 0.2% ± 0.7%, P < .01; lateral spine, -0.6% ± 1.0%; P < .01). The results remained significant after controlling for baseline body mass index, P1NP, and IGF-1. Changes in femoral neck (P = .4) and total hip (P = 0.8) BMD were comparable in both groups, as were changes in weight. Serum P1NP levels increased after 3 months of TPT treatment and remained at this higher level at 6 months, whereas P1NP levels were unchanged in the placebo group (P = .02). TPT was well-tolerated by all subjects. CONCLUSIONS: This study demonstrates that TPT administration increases spine BMD substantially after only 6 months of therapy in women with AN.
Authors: Catherine M Gordon; Estherann Grace; S Jean Emans; Henry A Feldman; Elizabeth Goodman; Kelly A Becker; Clifford J Rosen; Caren M Gundberg; Meryl S LeBoff Journal: J Clin Endocrinol Metab Date: 2002-11 Impact factor: 5.958
Authors: Madhusmita Misra; Debra Katzman; Karen K Miller; Nara Mendes; Deirdre Snelgrove; Melissa Russell; Mark A Goldstein; Seda Ebrahimi; Laura Clauss; Thomas Weigel; Diane Mickley; David A Schoenfeld; David B Herzog; Anne Klibanski Journal: J Bone Miner Res Date: 2011-10 Impact factor: 6.741
Authors: S A Polyzos; A D Anastasilakis; C Bratengeier; W Woloszczuk; A Papatheodorou; E Terpos Journal: Osteoporos Int Date: 2011-01-11 Impact factor: 4.507
Authors: Amy D Divasta; Henry A Feldman; Courtney Giancaterino; Clifford J Rosen; Meryl S Leboff; Catherine M Gordon Journal: Metabolism Date: 2012-01-16 Impact factor: 8.694
Authors: Karen K Miller; Erinne Meenaghan; Elizabeth A Lawson; Madhusmita Misra; Suzanne Gleysteen; David Schoenfeld; David Herzog; Anne Klibanski Journal: J Clin Endocrinol Metab Date: 2011-04-27 Impact factor: 5.958
Authors: Pouneh K Fazeli; Elizabeth A Lawson; Rajani Prabhakaran; Karen K Miller; Daniel A Donoho; David R Clemmons; David B Herzog; Madhusmita Misra; Anne Klibanski Journal: J Clin Endocrinol Metab Date: 2010-07-28 Impact factor: 5.958
Authors: Matthew T Drake; Bhuma Srinivasan; Ulrike I Mödder; James M Peterson; Louise K McCready; B Lawrence Riggs; Denise Dwyer; Marina Stolina; Paul Kostenuik; Sundeep Khosla Journal: J Clin Endocrinol Metab Date: 2010-07-14 Impact factor: 5.958
Authors: Katherine Neubecker Bachmann; Pouneh K Fazeli; Elizabeth A Lawson; Brian M Russell; Ariana D Riccio; Erinne Meenaghan; Anu V Gerweck; Kamryn Eddy; Tara Holmes; Mark Goldstein; Thomas Weigel; Seda Ebrahimi; Diane Mickley; Suzanne Gleysteen; Miriam A Bredella; Anne Klibanski; Karen K Miller Journal: J Clin Endocrinol Metab Date: 2014-12 Impact factor: 5.958