Carlos A. Ramos, Barbara Savoldo, Vicky Torrano, Brandon Ballard, Huimin Zhang, Olga Dakhova, Enli Liu, George Carrum, Rammurti T. Kamble, Adrian P. Gee, Zhuyong Mei, Meng-Fen Wu, Hao Liu, Bambi Grilley, Cliona M. Rooney, Malcolm K. Brenner, Helen E. Heslop, Gianpietro Dotti
Martina Absinta, Pascal Sati, Matthew Schindler, Emily C. Leibovitch, Joan Ohayon, Tianxia Wu, Alessandro Meani, Massimo Filippi, Steven Jacobson, Irene C.M. Cortese, Daniel S. Reich
Matthew C. Frise, Hung-Yuan Cheng, Annabel H. Nickol, M. Kate Curtis, Karen A. Pollard, David J. Roberts, Peter J. Ratcliffe, Keith L. Dorrington, Peter A. Robbins
Cameron J. Turtle, Laïla-Aïcha Hanafi, Carolina Berger, Theodore A. Gooley, Sindhu Cherian, Michael Hudecek, Daniel Sommermeyer, Katherine Melville, Barbara Pender, Tanya M. Budiarto, Emily Robinson, Natalia N. Steevens, Colette Chaney, Lorinda Soma, Xueyan Chen, Cecilia Yeung, Brent Wood, Daniel Li, Jianhong Cao, Shelly Heimfeld, Michael C. Jensen, Stanley R. Riddell, David G. Maloney
BACKGROUND. Clinical laboratory tests are now being prescribed and made directly available to consumers through retail outlets in the USA. Concerns with these test have been raised regarding the uncertainty of testing methods used in these venues and a lack of open, scientific validation of the technical accuracy and clinical equivalency of results obtained through these services.
METHODS. We conducted a cohort study of 60 healthy adults to compare the uncertainty and accuracy in 22 common clinical lab tests between one company offering blood tests obtained from finger prick (Theranos) and 2 major clinical testing services that require standard venipuncture draws (Quest and LabCorp). Samples were collected in Phoenix, Arizona, at an ambulatory clinic and at retail outlets with point-of-care services.
RESULTS. Theranos flagged tests outside their normal range 1.6× more often than other testing services (
CONCLUSION. While laboratory practice standards exist to control this variability, the disparities between testing services we observed could potentially alter clinical interpretation and health care utilization. Greater transparency and evaluation of testing technologies would increase their utility in personalized health management.
FUNDING. This work was supported by the Icahn Institute for Genomics and Multiscale Biology, a gift from the Harris Family Charitable Foundation (to J.T. Dudley), and grants from the NIH (R01 DK098242 and U54 CA189201, to J.T. Dudley, and R01 AG046170 and U01 AI111598, to E.E. Schadt).
Brian A. Kidd, Gabriel Hoffman, Noah Zimmerman, Li Li, Joseph W. Morgan, Patricia K. Glowe, Gregory J. Botwin, Samir Parekh, Nikolina Babic, Matthew W. Doust, Gregory B. Stock, Eric E. Schadt, Joel T. Dudley
Bernhard Voller, Emily Lines, Gayle McCrossin, Sule Tinaz, Codrin Lungu, George Grimes, Judith Starling, Gopal Potti, Peter Buchwald, Dietrich Haubenberger, Mark Hallett
BACKGROUND. Severe gonadal steroid deficiency induces bone loss in adult men; however, the specific roles of androgen and estrogen deficiency in hypogonadal bone loss are unclear. Additionally, the threshold levels of testosterone and estradiol that initiate bone loss are uncertain.
METHODS. One hundred ninety-eight healthy men, ages 20–50, received goserelin acetate, which suppresses endogenous gonadal steroid production, and were randomized to treatment with 0, 1.25, 2.5, 5, or 10 grams of testosterone gel daily for 16 weeks. An additional cohort of 202 men was randomized to receive these treatments plus anastrozole, which suppresses conversion of androgens to estrogens. Thirty-seven men served as controls and received placebos for goserelin and testosterone. Changes in bone turnover markers, bone mineral density (BMD) by dual-energy x-ray absorptiometry (DXA), and BMD by quantitative computed tomography (QCT) were assessed in all men. Bone microarchitecture was assessed in 100 men.
RESULTS. As testosterone dosage decreased, the percent change in C-telopeptide increased. These increases were considerably greater when aromatization of testosterone to estradiol was also suppressed, suggesting effects of both testosterone and estradiol deficiency. Decreases in DXA BMD were observed when aromatization was suppressed but were modest in most groups. QCT spine BMD fell substantially in all testosterone-dose groups in which aromatization was also suppressed, and this decline was independent of testosterone dose. Estradiol deficiency disrupted cortical microarchitecture at peripheral sites. Estradiol levels above 10 pg/ml and testosterone levels above 200 ng/dl were generally sufficient to prevent increases in bone resorption and decreases in BMD in men.
CONCLUSIONS. Estrogens primarily regulate bone homeostasis in adult men, and testosterone and estradiol levels must decline substantially to impact the skeleton.
TRIAL REGISTRATION. ClinicalTrials.gov, NCT00114114.
FUNDING. AbbVie Inc., AstraZeneca Pharmaceuticals LP, NIH.
Joel S. Finkelstein, Hang Lee, Benjamin Z. Leder, Sherri-Ann M. Burnett-Bowie, David W. Goldstein, Christopher W. Hahn, Sarah C. Hirsch, Alex Linker, Nicholas Perros, Andrew B. Servais, Alexander P. Taylor, Matthew L. Webb, Jonathan M. Youngner, Elaine W. Yu
Iñigo Landa, Tihana Ibrahimpasic, Laura Boucai, Rileen Sinha, Jeffrey A. Knauf, Ronak H. Shah, Snjezana Dogan, Julio C. Ricarte-Filho, Gnana P. Krishnamoorthy, Bin Xu, Nikolaus Schultz, Michael F. Berger, Chris Sander, Barry S. Taylor, Ronald Ghossein, Ian Ganly, James A. Fagin
Raymond P. Najjar, Jamie M. Zeitzer
Yavuz Bayram, Ender Karaca, Zeynep Coban Akdemir, Elif Ozdamar Yilmaz, Gulsen Akay Tayfun, Hatip Aydin, Deniz Torun, Sevcan Tug Bozdogan, Alper Gezdirici, Sedat Isikay, Mehmed M. Atik, Tomasz Gambin, Tamar Harel, Ayman W. El-Hattab, Wu-Lin Charng, Davut Pehlivan, Shalini N. Jhangiani, Donna M. Muzny, Ali Karaman, Tamer Celik, Ozge Ozalp Yuregir, Timur Yildirim, Ilhan A. Bayhan, Eric Boerwinkle, Richard A. Gibbs, Nursel Elcioglu, Beyhan Tuysuz, James R. Lupski
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