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1. Long-term Outcomes with Spinal versus General Anesthesia for Hip Fracture Surgery: A Randomized Trial

Author

Vail, Emily A., Feng, Rui, Sieber, Frederick, Carson, Jeffrey L., Ellenberg, Susan S., Magaziner, Jay, Dillane, Derek, Marcantonio, Edward R., Sessler, Daniel I., Ayad, Sabry, Stone, Trevor, Papp, Steven, Donegan, Derek, Mehta, Samir, Schwenk, Eric S., Marshall, Mitchell, Jaffe, J. Douglas, Luke, Charles, Sharma, Balram, Azim, Syed, Hymes, Robert, Chin, Ki-Jinn, Sheppard, Richard, Perlman, Barry, Sappenfield, Joshua, Hauck, Ellen, Tierney, Ann, Horan, Annamarie D., Neuman, Mark D., Looke, Thomas, Bent, Sandra, Franco-Mora, Ariana, Hedrick, Pamela, Newbern, Matthew, Tadros, Rafik, Pealer, Karen, Vlassakov, Kamen, Buckley, Carolyn, Gavin, Lauren, Gorbatov, Svetlana, Gosnell, James, Steen, Talora, Vafai, Avery, Zeballos, Jose, Hruslinski, Jennifer, Cardenas, Louis, Berry, Ashley, Getchell, John, Quercetti, Nicholas, Hassan, Manal, Bajracharya, Gauasan, Billow, Damien, Bloomfield, Michael, Cuko, Evis, Elyaderani, Mehrun K., Hampton, Robert, Honar, Hooman, Khoshknabi, Dilara, Kim, Daniel, Krahe, David, Lew, Michael M., Maheshwer, Conjeevram B., Niazi, Azfar, Saha, Partha, Salih, Ahmed, de Swart, Robert J., Volio, Andrew, Bolkus, Kelly, DeAngelis, Matthew, Dodson, Gregory, Gerritsen, Jeffrey, McEniry, Brian, Mitrev, Ludmil, Kwofie, M. Kwesi, Belliveau, Anne, Bonazza, Flynn, Lloyd, Vera, Panek, Izabela, Dabiri, Jared, Chavez, Chris, Craig, Jason, Davidson, Todd, Dietrichs, Chad, Fleetwood, Cheryl, Foley, Mike, Getto, Chris, Hailes, Susie, Hermes, Sarah, Hooper, Andy, Koener, Greg, Kohls, Kate, Law, Leslie, Lipp, Adam, Losey, Allison, Nelson, William, Nieto, Mario, Rogers, Pam, Rutman, Steve, Scales, Garrett, Sebastian, Barbara, Stanciu, Tom, Lobel, Gregg, Giampiccolo, Michelle, Herman, Dara, Kaufman, Margit, Murphy, Bryan, Pau, Clara, Puzio, Thomas, Veselsky, Marlene, Apostle, Kelly, Boyer, Dory, Chen Fan, Brenda, Lee, Susan, Lemke, Mike, Merchant, Richard, Moola, Farhad, Payne, Kyrsten, Perey, Bertrand, Viskontas, Darius, Poler, Mark, D’Antonio, Patricia, O’Neill, Greg, Abdullah, Amer, Fish-Fuhrmann, Jamie, Giska, Mark, Fidkowski, Christina, Guthrie, Stuart Trent, Hakeos, William, Hayes, Lillian, Hoegler, Joseph, Nowak, Katherine, Beck, Jeffery, Cuff, Jaslynn, Gaski, Greg, Haaser, Sharon, Holzman, Michael, Malekzadeh, A. Stephen, Ramsey, Lolita, Schulman, Jeff, Schwartzbach, Cary, Azefor, Tangwan, Davani, Arman, Jaberi, Mahmood, Masear, Courtney, Haider, Syed Basit, Chungu, Carolyn, Ebrahimi, Ali, Fikry, Karim, Marcantonio, Andrew, Shelvan, Anitha, Sanders, David, Clarke, Collin, Lawendy, Abdel, Schwartz, Gary, Garg, Mohit, Kim, Joseph, Caruci, Juan, Commeh, Ekow, Cuevas, Randy, Cuff, Germaine, Franco, Lola, Furgiuele, David, Giuca, Matthew, Allman, Melissa, Barzideh, Omid, Cossaro, James, D’Arduini, Armando, Farhi, Anita, Gould, Jason, Kafel, John, Patel, Anuj, Peller, Abraham, Reshef, Hadas, Safur, Mohammed, Toscano, Fiore, Tedore, Tiffany, Akerman, Michael, Brumberger, Eric, Clark, Sunday, Friedlander, Rachel, Jegarl, Anita, Lane, Joseph, Lyden, John P., Mehta, Nili, Murrell, Matthew T., Painter, Nathan, Ricci, William, Sbrollini, Kaitlyn, Sharma, Rahul, Steel, Peter A.D., Steinkamp, Michele, Weinberg, Roniel, Stephenson Wellman, David, Nader, Antoun, Fitzgerald, Paul, Ritz, Michaela, Bryson, Greg, Craig, Alexandra, Farhat, Cassandra, Gammon, Braden, Gofton, Wade, Harris, Nicole, Lalonde, Karl, Liew, Allan, Meulenkamp, Bradley, Sonnenburg, Kendra, Wai, Eugene, Wilkin, Geoffrey, Troxell, Karen, Alderfer, Mary Ellen, Brannen, Jason, Cupitt, Christopher, Gerhart, Stacy, McLin, Renee, Sheidy, Julie, Yurick, Katherine, Chen, Fei, Dragert, Karen, Kiss, Geza, Malveaux, Halina, McCloskey, Deborah, Mellender, Scott, Mungekar, Sagar S., Noveck, Helaine, Sagebien, Carlos, Biby, Luat, McKelvy, Gail, Richards, Anna, Abola, Ramon, Ayala, Brittney, Halper, Darcy, Mavarez, Ana, Rizwan, Sabeen, Choi, Stephen, Awad, Imad, Flynn, Brendan, Henry, Patrick, Jenkinson, Richard, Kaustov, Lilia, Lappin, Elizabeth, McHardy, Paul, Singh, Amara, Donnelly, Joanne, Gonzalez, Meera, Haydel, Christopher, Livelsberger, Jon, Pazionis, Theresa, Slattery, Bridget, Vazquez-Trejo, Maritza, Baratta, Jaime, Cirullo, Michael, Deiling, Brittany, Deschamps, Laura, Glick, Michael, Katz, Daniel, Krieg, James, Lessin, Jennifer, Mojica, Jeffrey, Torjman, Marc, Jin, Rongyu, Salpeter, Mary Jane, Powell, Mark, Simmons, Jeffrey, Lawson, Prentiss, Kukreja, Promil, Graves, Shanna, Sturdivant, Adam, Bryant, Ayesha, Crump, Sandra Joyce, Verrier, Michelle, Green, James, Menon, Matthew, Applegate, Richard, Arias, Ana, Pineiro, Natasha, Uppington, Jeffrey, Wolinsky, Phillip, Gunnett, Amy, Hagen, Jennifer, Harris, Sara, Hollen, Kevin, Holloway, Brian, Horodyski, Mary Beth, Pogue, Trevor, Ramani, Ramachandran, Smith, Cameron, Woods, Anna, Warrick, Matthew, Flynn, Kelly, Mongan, Paul, Ranganath, Yatish, Fernholz, Sean, Ingersoll-Weng, Esperanza, Marian, Anil, Seering, Melinda, Sibenaller, Zita, Stout, Lori, Wagner, Allison, Walter, Alicia, Wong, Cynthia, Orwig, Denise, Goud, Maithri, Helker, Chris, Mezenghie, Lydia, Montgomery, Brittany, Preston, Peter, Schwartz, J. Sanford, Weber, Ramona, Fleisher, Lee A., Mehta, Samir, Stephens-Shields, Alisa J., Dinh, Cassandra, Schwartz, Aron, Chelly, Jacques E., Goel, Shiv, Goncz, Wende, Kawabe, Touichi, Khetarpal, Sharad, Monroe, Amy, Shick, Vladislav, Breidenstein, Max, Dominick, Timothy, Friend, Alexander, Mathews, Donald, Lennertz, Richard, Sanders, Robert, Akere, Helen, Balweg, Tyler, Bo, Amber, Doro, Christopher, Goodspeed, David, Lang, Gerald, Parker, Maggie, Rettammel, Amy, Roth, Mary, White, Marissa, Whiting, Paul, Allen, Brian F.S., Baker, Tracie, Craven, Debra, McEvoy, Matt, Turnbo, Teresa, Kates, Stephen, Morgan, Melanie, Willoughby, Teresa, Weigel, Wade, Auyong, David, Fox, Ellie, Welsh, Tina, Cusson, Bruce, Dobson, Sean, Edwards, Christopher, Harris, Lynette, Henshaw, Daryl, Johnson, Kathleen, McKinney, Glen, Miller, Scott, Reynolds, Jon, Segal, B. Scott, Turner, Jimmy, VanEenenaam, David, Weller, Robert, Lei, Jineli, Treggiari, Miriam, Akhtar, Shamsuddin, Blessing, Marcelle, Johnson, Chanel, Kampp, Michael, Kunze, Kimberly, OʼConnor, Mary, Gaskins, Lakisha J., Looke, Thomas, Tadros, Rafik, Vlassakov, Kamen, Cardenas, Louis, Hassan, Manal, Bolkus, Kelly, Mitrev, Ludmil, Kwofie, M. Kwesi, Dabiri, Jared, Lobel, Gregg, Poler, Mark, Giska, Mark, Sanders, David, Schwartz, Gary, Giuca, Matthew, Tedore, Tiffany, Nader, Antoun, Papp, Stephen, Bryson, Greg, Troxell, Karen, Kiss, Geza, Choi, Stephen, Powell, Mark, Applegate, Richard, Warrick, Matthew, Ranganath, Yatish, Elkassabany, Nabil, Chelly, Jacques E., Hoeft, Mark A., Lennertz, Richard, Sanders, Robert, Allen, Brian F.S., Kates, Stephen, Weigel, Wade, Li, Jinlei, Wijeysundera, Duminda N., Kheterpal, Sachin, Moore, Reneé H., Smith, Alexander K., Tosi, Laura L., Elkassabany, Nabil, Looke, Thomas, Menio, Diane, Mehta, Samir, Fleisher, Lee, Menio, Diane, Hruslinski, Jennifer, Ramsey, Lolita, Gaskins, Lakisha J., Langlois, Christine, Gaskins, Lakisha J., Mezenghie, Lydia, Montgomery, Brittany, Oduwole, Samuel, and Rose, Thomas

Published
2024
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3. Biomarkers and Noncalcified Coronary Artery Plaque Progression in Older Men Treated With Testosterone

Author

Shaikh, Kashif, Ellenberg, Susan S, Nakanishi, Rine, Snyder, Peter J, Lee, Juhwan, Wenger, Nanette K, Lewis, Cora E, Swerdloff, Ronald S, Preston, Peter, Hamal, Sajad, Stephens-Sheilds, Alisa, Bhasin, Shalender, Cherukuri, Lavanya, Cauley, Jane A, Crandall, Jill P, Cunningham, Glenn R, Ensrud, Kristine E, Matsumoto, Alvin M, Molich, Mark E, Alla, Venkata M, Birudaraju, Divya, Nezarat, Negin, Rai, Kelash, Almeida, Shone, Roy, Sion K, Sheikh, Mohammad, Trad, George, and Budoff, Mathew J

Subjects
Heart Disease, Clinical Research, Cardiovascular, Atherosclerosis, Clinical Trials and Supportive Activities, Aging, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Aged, Anthropometry, Biomarkers, Coronary Artery Disease, Disease Progression, Heart Disease Risk Factors, Hormone Replacement Therapy, Humans, Hypogonadism, Male, Plaque, Atherosclerotic, Testosterone, noncalcified coronary artery plaque, coronary artery disease, testosterone replacement, Clinical Sciences, Paediatrics and Reproductive Medicine, Endocrinology & Metabolism
Abstract

Recent results from the Cardiovascular Trial of the Testosterone Trials showed that testosterone treatment of older men with low testosterone was associated with greater progression of noncalcified plaque (NCP). We evaluated the effect of anthropometric measures and cardiovascular biomarkers on plaque progression in individuals in the Testosterone Trial. The Cardiovascular part of the trial included 170 men aged 65 years or older with low testosterone. Participants received testosterone gel or placebo gel for 12 months. The primary outcome was change in NCP volume from baseline to 12 months, as determined by coronary computed tomography angiography (CCTA). We assayed several markers of cardiovascular risk and analyzed each marker individually in a model as predictive variables and change in NCP as the dependent variable. Of 170 enrollees, 138 (73 testosterone, 65 placebo) completed the study and were available for the primary analysis. Of 10 markers evaluated, none showed a significant association with the change in NCP volume, but a significant interaction between treatment assignment and waist-hip ratio (WHR) (P = 0.0014) indicated that this variable impacted the testosterone effect on NCP volume. The statistical model indicated that for every 0.1 change in the WHR, the testosterone-induced 12-month change in NCP volume increased by 26.96 mm3 (95% confidence interval, 7.72-46.20). Among older men with low testosterone treated for 1 year, greater WHR was associated with greater NCP progression, as measured by CCTA. Other biomarkers and anthropometric measures did not show statistically significant association with plaque progression.

Published
2020

4. Pulmonary Hypertension and Anastrozole (PHANTOM): A Randomized, Double-Blind, Placebo-Controlled Trial

Author

Kawut, Steven M, primary, Feng, Rui, additional, Ellenberg, Susan S., additional, Zamanian, Roham, additional, Bull, Todd, additional, Chakinala, Murali, additional, Mathai, Stephen C., additional, Hemnes, Anna, additional, Lin, Grace, additional, Doyle, Margaret, additional, Andrew, Ruth, additional, MacLean, Margaret, additional, Stasinopoulos, Ioannis, additional, Austin, Eric, additional, DeMichele, Angela, additional, Shou, Haochang, additional, Minhas, Jasleen, additional, Song, Nianfu, additional, Moutchia, Jude, additional, and Ventetuolo, Corey E, additional

Published
2024
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5. The Effect of Testosterone on Cardiovascular Biomarkers in the Testosterone Trials.

Author

Mohler, Emile R, Ellenberg, Susan S, Lewis, Cora E, Wenger, Nanette K, Budoff, Matthew J, Lewis, Michael R, Barrett-Connor, Elizabeth, Swerdloff, Ronald S, Stephens-Shields, Alisa, Bhasin, Shalender, Cauley, Jane A, Crandall, Jill P, Cunningham, Glenn R, Ensrud, Kristine E, Gill, Thomas M, Matsumoto, Alvin M, Molitch, Mark E, Pahor, Marco, Preston, Peter E, Hou, Xiaoling, Cifelli, Denise, and Snyder, Peter J

Subjects
Aging, Cardiovascular, Prevention, Clinical Research, Heart Disease, Diabetes, Clinical Trials and Supportive Activities, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Aged, Aged, 80 and over, Biomarkers, Cardiovascular System, Double-Blind Method, Hormone Replacement Therapy, Humans, Hypogonadism, Male, Testosterone, United States, Clinical Sciences, Paediatrics and Reproductive Medicine, Endocrinology & Metabolism
Abstract

Context:Studies of the possible cardiovascular risk of testosterone treatment are inconclusive. Objective:To determine the effect of testosterone treatment on cardiovascular biomarkers in older men with low testosterone. Design:Double-blind, placebo-controlled trial. Setting:Twelve academic medical centers in the United States. Participants:In all, 788 men ≥65 years old with an average of two serum testosterone levels

Published
2018

7. Testosterone Treatment and Fractures in Men with Hypogonadism

Author

Snyder, Peter J., primary, Bauer, Douglas C., additional, Ellenberg, Susan S., additional, Cauley, Jane A., additional, Buhr, Kevin A., additional, Bhasin, Shalender, additional, Miller, Michael G., additional, Khan, Nader S., additional, Li, Xue, additional, and Nissen, Steven E., additional

Published
2024
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8. Changes in Coronary Artery Plaque With Testosterone Therapy—Reply

Author

Budoff, Matthew J, Ellenberg, Susan S, and Snyder, Peter J

Subjects
Coronary Angiography, Coronary Artery Disease, Coronary Vessels, Humans, Plaque, Amyloid, Plaque, Atherosclerotic, Testosterone, Medical and Health Sciences, General & Internal Medicine
Published
2017

9. Effect of Testosterone Treatment on Volumetric Bone Density and Strength in Older Men With Low Testosterone: A Controlled Clinical Trial

Author

Snyder, Peter J, Kopperdahl, David L, Stephens-Shields, Alisa J, Ellenberg, Susan S, Cauley, Jane A, Ensrud, Kristine E, Lewis, Cora E, Barrett-Connor, Elizabeth, Schwartz, Ann V, Lee, David C, Bhasin, Shalender, Cunningham, Glenn R, Gill, Thomas M, Matsumoto, Alvin M, Swerdloff, Ronald S, Basaria, Shehzad, Diem, Susan J, Wang, Christina, Hou, Xiaoling, Cifelli, Denise, Dougar, Darlene, Zeldow, Bret, Bauer, Douglas C, and Keaveny, Tony M

Subjects
Clinical Trials and Supportive Activities, Clinical Research, Prevention, Osteoporosis, Aging, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Musculoskeletal, Absorptiometry, Photon, Aged, Androgens, Bone Density, Double-Blind Method, Drug Administration Routes, Drug Monitoring, Hip Fractures, Humans, Lumbar Vertebrae, Male, Spinal Fractures, Testosterone, Tomography, X-Ray Computed, Treatment Outcome, Clinical Sciences, Opthalmology and Optometry, Public Health and Health Services
Abstract

ImportanceAs men age, they experience decreased serum testosterone concentrations, decreased bone mineral density (BMD), and increased risk of fracture.ObjectiveTo determine whether testosterone treatment of older men with low testosterone increases volumetric BMD (vBMD) and estimated bone strength.Design, setting, and participantsPlacebo-controlled, double-blind trial with treatment allocation by minimization at 9 US academic medical centers of men 65 years or older with 2 testosterone concentrations averaging less than 275 ng/L participating in the Testosterone Trials from December 2011 to June 2014. The analysis was a modified intent-to-treat comparison of treatment groups by multivariable linear regression adjusted for balancing factors as required by minimization.InterventionsTestosterone gel, adjusted to maintain the testosterone level within the normal range for young men, or placebo gel for 1 year.Main outcomes and measuresSpine and hip vBMD was determined by quantitative computed tomography at baseline and 12 months. Bone strength was estimated by finite element analysis of quantitative computed tomography data. Areal BMD was assessed by dual energy x-ray absorptiometry at baseline and 12 months.ResultsThere were 211 participants (mean [SD] age, 72.3 [5.9] years; 86% white; mean [SD] body mass index, 31.2 [3.4]). Testosterone treatment was associated with significantly greater increases than placebo in mean spine trabecular vBMD (7.5%; 95% CI, 4.8% to 10.3% vs 0.8%; 95% CI, -1.9% to 3.4%; treatment effect, 6.8%; 95% CI, 4.8%-8.7%; P

Published
2017

10. Testosterone Treatment and Coronary Artery Plaque Volume in Older Men With Low Testosterone

Author

Budoff, Matthew J, Ellenberg, Susan S, Lewis, Cora E, Mohler, Emile R, Wenger, Nanette K, Bhasin, Shalender, Barrett-Connor, Elizabeth, Swerdloff, Ronald S, Stephens-Shields, Alisa, Cauley, Jane A, Crandall, Jill P, Cunningham, Glenn R, Ensrud, Kristine E, Gill, Thomas M, Matsumoto, Alvin M, Molitch, Mark E, Nakanishi, Rine, Nezarat, Negin, Matsumoto, Suguru, Hou, Xiaoling, Basaria, Shehzad, Diem, Susan J, Wang, Christina, Cifelli, Denise, and Snyder, Peter J

Subjects
Aging, Clinical Trials and Supportive Activities, Cardiovascular, Heart Disease, Atherosclerosis, Heart Disease - Coronary Heart Disease, Prevention, Clinical Research, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Aged, Androgens, Coronary Angiography, Coronary Artery Disease, Disease Progression, Double-Blind Method, Gels, Hormone Replacement Therapy, Humans, Hypogonadism, Male, Observer Variation, Sample Size, Testosterone, United States, Vascular Calcification, Medical and Health Sciences, General & Internal Medicine
Abstract

ImportanceRecent studies have yielded conflicting results as to whether testosterone treatment increases cardiovascular risk.ObjectiveTo test the hypothesis that testosterone treatment of older men with low testosterone slows progression of noncalcified coronary artery plaque volume.Design, setting, and participantsDouble-blinded, placebo-controlled trial at 9 academic medical centers in the United States. The participants were 170 of 788 men aged 65 years or older with an average of 2 serum testosterone levels lower than 275 ng/dL (82 men assigned to placebo, 88 to testosterone) and symptoms suggestive of hypogonadism who were enrolled in the Testosterone Trials between June 24, 2010, and June 9, 2014.InterventionTestosterone gel, with the dose adjusted to maintain the testosterone level in the normal range for young men, or placebo gel for 12 months.Main outcomes and measuresThe primary outcome was noncalcified coronary artery plaque volume, as determined by coronary computed tomographic angiography. Secondary outcomes included total coronary artery plaque volume and coronary artery calcium score (range of 0 to >400 Agatston units, with higher values indicating more severe atherosclerosis).ResultsOf 170 men who were enrolled, 138 (73 receiving testosterone treatment and 65 receiving placebo) completed the study and were available for the primary analysis. Among the 138 men, the mean (SD) age was 71.2 (5.7) years, and 81% were white. At baseline, 70 men (50.7%) had a coronary artery calcification score higher than 300 Agatston units, reflecting severe atherosclerosis. For the primary outcome, testosterone treatment compared with placebo was associated with a significantly greater increase in noncalcified plaque volume from baseline to 12 months (from median values of 204 mm3 to 232 mm3 vs 317 mm3 to 325 mm3, respectively; estimated difference, 41 mm3; 95% CI, 14 to 67 mm3; P = .003). For the secondary outcomes, the median total plaque volume increased from baseline to 12 months from 272 mm3 to 318 mm3 in the testosterone group vs from 499 mm3 to 541 mm3 in the placebo group (estimated difference, 47 mm3; 95% CI, 13 to 80 mm3; P = .006), and the median coronary artery calcification score changed from 255 to 244 Agatston units in the testosterone group vs 494 to 503 Agatston units in the placebo group (estimated difference, -27 Agatston units; 95% CI, -80 to 26 Agatston units). No major adverse cardiovascular events occurred in either group.Conclusions and relevanceAmong older men with symptomatic hypogonadism, treatment with testosterone gel for 1 year compared with placebo was associated with a significantly greater increase in coronary artery noncalcified plaque volume, as measured by coronary computed tomographic angiography. Larger studies are needed to understand the clinical implications of this finding.Trial registrationclinicaltrials.gov Identifier: NCT00799617.

Published
2017

11. Benefit–risk assessment and reporting in clinical trials of chronic pain treatments: IMMPACT recommendations

Author

Kleykamp, Bethea A., Dworkin, Robert H., Turk, Dennis C., Bhagwagar, Zubin, Cowan, Penney, Eccleston, Christopher, Ellenberg, Susan S., Evans, Scott R., Farrar, John T., Freeman, Roy L., Garrison, Louis P., Gewandter, Jennifer S., Goli, Veeraindar, Iyengar, Smriti, Jadad, Alejandro R., Jensen, Mark P., Junor, Roderick, Katz, Nathaniel P., Kesslak, J. Patrick, Kopecky, Ernest A., Lissin, Dmitri, Markman, John D., McDermott, Michael P., Mease, Philip J., OʼConnor, Alec B., Patel, Kushang V., Raja, Srinivasa N., Rowbotham, Michael C., Sampaio, Cristina, Singh, Jasvinder A., Steigerwald, Ilona, Strand, Vibeke, Tive, Leslie A., Tobias, Jeffrey, Wasan, Ajay D., and Wilson, Hilary D.

Published
2022
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12. The Cardiovascular Trial of the Testosterone Trials

Author

alamir, Moshrik Abd, Ellenberg, Susan S, Swerdloff, Ronald S, Wenger, Nanette K, Mohler, Emile R, Lewis, Cora E, Barrett-Conner, Elizabeth, Nakanishi, Rine, Darabian, Sirous, Alani, Anas, Matsumoto, Suguru, Nezarat, Negin, Snyder, Peter J, and Budoff, Matthew J

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Clinical Trials and Supportive Activities, Heart Disease, Aging, Cardiovascular, Clinical Research, Atherosclerosis, Heart Disease - Coronary Heart Disease, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Aged, Androgens, Coronary Angiography, Coronary Artery Disease, Disease Progression, Double-Blind Method, Hormone Replacement Therapy, Humans, Hypogonadism, Male, Testosterone, Tomography, X-Ray Computed, cardiovascular disease, coronary artery plaque progression, coronary computed tomographic angiography, randomized controlled trial, testosterone, Cardiovascular System & Hematology, Cardiovascular medicine and haematology, Clinical sciences
Abstract

BackgroundData from prior studies have yielded inconsistent results on the association of serum testosterone levels with the risk for cardiovascular disease. There are no clinical trial data on the effects of testosterone replacement therapy on plaque progression.ObjectiveWe designed a study to investigate the effect of testosterone therapy on coronary artery plaque progression using serial coronary computed tomographic angiography (CCTA). In this paper, we describe the study design, methods, and characteristics of the study population.MethodsThe Cardiovascular Trial of the Testosterone Trials (TTrials; NCT00799617) is a double-blind, placebo-controlled trial of 1 year of testosterone therapy in men 65 years or older with clinical manifestations of androgen deficiency and unequivocally low serum testosterone concentrations (

Published
2016

13. The Cardiovascular Trial of the Testosterone Trials: rationale, design, and baseline data of a clinical trial using computed tomographic imaging to assess the progression of coronary atherosclerosis.

Author

Abd Alamir, Moshrik, Ellenberg, Susan S, Swerdloff, Ronald S, Wenger, Nanette K, Mohler, Emile R, Lewis, Cora E, Barrett-Conner, Elizabeth, Nakanishi, Rine, Darabian, Sirous, Alani, Anas, Matsumoto, Suguru, Nezarat, Negin, Snyder, Peter J, and Budoff, Matthew J

Subjects
Humans, Hypogonadism, Disease Progression, Testosterone, Androgens, Tomography, X-Ray Computed, Coronary Angiography, Hormone Replacement Therapy, Double-Blind Method, Aged, Male, Coronary Artery Disease, cardiovascular disease, coronary artery plaque progression, coronary computed tomographic angiography, randomized controlled trial, testosterone, Tomography, X-Ray Computed, Cardiovascular System & Hematology, Clinical Sciences
Abstract

BackgroundData from prior studies have yielded inconsistent results on the association of serum testosterone levels with the risk for cardiovascular disease. There are no clinical trial data on the effects of testosterone replacement therapy on plaque progression.ObjectiveWe designed a study to investigate the effect of testosterone therapy on coronary artery plaque progression using serial coronary computed tomographic angiography (CCTA). In this paper, we describe the study design, methods, and characteristics of the study population.MethodsThe Cardiovascular Trial of the Testosterone Trials (TTrials; NCT00799617) is a double-blind, placebo-controlled trial of 1 year of testosterone therapy in men 65 years or older with clinical manifestations of androgen deficiency and unequivocally low serum testosterone concentrations (

Published
2016

14. Symptomatic benefits of testosterone treatment in patient subgroups: a systematic review, individual participant data meta-analysis, and aggregate data meta-analysis

Author

Hudson, Jemma, primary, Cruickshank, Moira, additional, Quinton, Richard, additional, Aucott, Lorna, additional, Wu, Frederick, additional, Grossmann, Mathis, additional, Bhasin, Shalender, additional, Snyder, Peter J, additional, Ellenberg, Susan S, additional, Travison, Thomas G, additional, Brock, Gerald B, additional, Gianatti, Emily J, additional, van der Schouw, Yvonne T, additional, Emmelot-Vonk, Marielle H, additional, Giltay, Erik J, additional, Hackett, Geoff, additional, Ramachandran, Sudarshan, additional, Svartberg, Johan, additional, Hildreth, Kerry L, additional, Antonic, Kristina Groti, additional, Tenover, Joyce Lisa, additional, Tan, Hui Meng, additional, Ho Chee Kong, Christopher, additional, Tan, Wei Shen, additional, Marks, Leonard S, additional, Ross, Richard J, additional, Schwartz, Robert S, additional, Manson, Paul, additional, Roberts, Stephen A, additional, Skovsager Andersen, Marianne, additional, Velling Magnussen, Line, additional, Aceves-Martins, Magaly, additional, Gillies, Katie, additional, Hernández, Rodolfo, additional, Oliver, Nick, additional, Dhillo, Waljit S, additional, Bhattacharya, Siladitya, additional, Brazzelli, Miriam, additional, and Jayasena, Channa N, additional

Published
2023
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15. Designing, Conducting, Monitoring, and Analyzing Data from Pragmatic Randomized Clinical Trials: Proceedings from a Multi-stakeholder Think Tank Meeting

Author

Lentz, Trevor A., Curtis, Lesley H., Rockhold, Frank W., Martin, David, Andersson, Tomas L. G., Arias, Carolyn, Berlin, Jesse A., Binns, Cherie, Cook, Andrea, Cziraky, Mark, Dent, Ricardo, Desai, Manisha, Emmett, Andrew, Esserman, Denise, George, Jyothis, Hantel, Stefan, Heagerty, Patrick, Hernandez, Adrian F., Hucko, Thomas, Khan, Naeem, Lee, Shun Fu, LoCasale, Robert, Mardekian, Jack, McCall, Debbe, Monda, Keri, Normand, Sharon-Lise, Riesmeyer, Jeffrey, Roe, Matthew, Roessig, Lothar, Scott, Rob, Siedentop, Harald, Waldstreicher, Joanne, Wang, Lin, Weerakkody, Govinda, Wolf, Myles, and Ellenberg, Susan S.

Published
2020
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16. Data monitoring committees for pragmatic clinical trials

Author

Ellenberg, Susan S, Culbertson, Richard, Gillen, Daniel L, Goodman, Steven, Schrandt, Suzanne, and Zirkle, Maryan

Subjects
Clinical Research, Rare Diseases, Patient Safety, Clinical Trials and Supportive Activities, Clinical Trials Data Monitoring Committees, Clinical Trials as Topic, Data Collection, Humans, Information Dissemination, Research Design, United States, Pragmatic clinical trials, cluster-randomized trials, data monitoring committee, early termination, biostatistics, Statistics, Clinical Sciences, Statistics & Probability
Abstract

In any clinical trial, it is essential to monitor the accumulating data to be sure that the trial continues to be safe for participants and that the trial is being conducted properly. Data monitoring committees, independent expert panels who undertake regular reviews of the data as the trial progresses, serve an important role in safeguarding the interests of research participants and ensuring trial integrity in many trials. Many pragmatic clinical trials, which aim to inform healthcare decisions by comparing alternate interventions in heterogeneous healthcare delivery settings, will warrant review by an independent data monitoring committee due to their potential impact on clinical practice. However, the very features that make a trial "pragmatic" may pose challenges in terms of which aspects of a trial to monitor and when it is appropriate for a data monitoring committee to intervene. Using the Pragmatic-Explanatory Continuum Indicator Summary tool that draws distinctions between pragmatic and explanatory clinical trials, we review characteristics of pragmatic clinical trials that may have implications for data monitoring committees and interim monitoring plans. These include broad eligibility criteria, a focus on subjective patient-centered outcomes, and in some cases a lack of standardized follow-up procedures across study sites. Additionally, protocol adherence is often purposefully not addressed in pragmatic trials in order to accurately represent the clinical practice setting and maintain practicability of implementation; there are differing viewpoints as to whether adherence should be assessed and acted upon by data monitoring committees in these trials. Some other issues not specifically related to the Pragmatic-Explanatory Continuum Indicator Summary criteria may also merit special consideration in pragmatic trials. Thresholds for early termination of a pragmatic clinical trial might be controversial. The distinguishing features of pragmatic clinical trials require careful consideration when developing interim data monitoring plans, and trial sponsors, investigators, and data monitoring committees should agree on a plan before trial inception. Finally, special expertise, such as an informatics, may be helpful on data monitoring committees for some pragmatic clinical trials. Patient representatives may provide particularly valuable insights in the monitoring process.

Published
2015

17. Effect of testosterone replacement on measures of mobility in older men with mobility limitation and low testosterone concentrations: secondary analyses of the Testosterone Trials

Author

Bhasin, Shalender, Ellenberg, Susan S, Storer, Thomas W, Basaria, Shehzad, Pahor, Marco, Stephens-Shields, Alisa J, Cauley, Jane A, Ensrud, Kristine E, Farrar, John T, Cella, David, Matsumoto, Alvin M, Cunningham, Glenn R, Swerdloff, Ronald S, Wang, Christina, Lewis, Cora E, Molitch, Mark E, Barrett-Connor, Elizabeth, Crandall, Jill P, Hou, Xiaoling, Preston, Peter, Cifelli, Denise, Snyder, Peter J, and Gill, Thomas M

Published
2018
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18. The Testosterone Trials: Seven coordinated trials of testosterone treatment in elderly men

Author

Snyder, Peter J, Ellenberg, Susan S, Cunningham, Glenn R, Matsumoto, Alvin M, Bhasin, Shalender, Barrett-Connor, Elizabeth, Gill, Thomas M, Farrar, John T, Cella, David, Rosen, Raymond C, Resnick, Susan M, Swerdloff, Ronald S, Cauley, Jane A, Cifelli, Denise, Fluharty, Laura, Pahor, Marco, Ensrud, Kristine E, Lewis, Cora E, Molitch, Mark E, Crandall, Jill P, Wang, Christina, Budoff, Matthew J, Wenger, Nanette K, Mohler, Emile R, Bild, Diane E, Cook, Nakela L, Keaveny, Tony M, Kopperdahl, David L, Lee, David, Schwartz, Ann V, Storer, Thomas W, Ershler, William B, Roy, Cindy N, Raffel, Leslie J, Romashkan, Sergei, and Hadley, Evan

Subjects
Biological Psychology, Biomedical and Clinical Sciences, Clinical Sciences, Psychology, Clinical Trials and Supportive Activities, Clinical Research, Cardiovascular, Aging, Aged, Clinical Trials as Topic, Hormone Replacement Therapy, Humans, Male, Research Design, Testosterone, Statistics, Statistics & Probability, Clinical sciences, Clinical and health psychology
Abstract

Background The prevalence of low testosterone levels in men increases with age, as does the prevalence of decreased mobility, sexual function, self-perceived vitality, cognitive abilities, bone mineral density, and glucose tolerance, and of increased anemia and coronary artery disease. Similar changes occur in men who have low serum testosterone concentrations due to known pituitary or testicular disease, and testosterone treatment improves the abnormalities. Prior studies of the effect of testosterone treatment in elderly men, however, have produced equivocal results. Purpose To describe a coordinated set of clinical trials designed to avoid the pitfalls of prior studies and to determine definitively whether testosterone treatment of elderly men with low testosterone is efficacious in improving symptoms and objective measures of age-associated conditions. Methods We present the scientific and clinical rationale for the decisions made in the design of this set of trials. Results We designed The Testosterone Trials as a coordinated set of seven trials to determine if testosterone treatment of elderly men with low serum testosterone concentrations and symptoms and objective evidence of impaired mobility and/or diminished libido and/or reduced vitality would be efficacious in improving mobility (Physical Function Trial), sexual function (Sexual Function Trial), fatigue (Vitality Trial), cognitive function (Cognitive Function Trial), hemoglobin (Anemia Trial), bone density (Bone Trial), and coronary artery plaque volume (Cardiovascular Trial). The scientific advantages of this coordination were common eligibility criteria, common approaches to treatment and monitoring, and the ability to pool safety data. The logistical advantages were a single steering committee, data coordinating center and data and safety monitoring board, the same clinical trial sites, and the possibility of men participating in multiple trials. The major consideration in participant selection was setting the eligibility criterion for serum testosterone low enough to ensure that the men were unequivocally testosterone deficient, but not so low as to preclude sufficient enrollment or eventual generalizability of the results. The major considerations in choosing primary outcomes for each trial were identifying those of the highest clinical importance and identifying the minimum clinically important differences between treatment arms for sample size estimation. Potential limitations Setting the serum testosterone concentration sufficiently low to ensure that most men would be unequivocally testosterone deficient, as well as many other entry criteria, resulted in screening approximately 30 men in person to randomize one participant. Conclusion Designing The Testosterone Trials as a coordinated set of seven trials afforded many important scientific and logistical advantages but required an intensive recruitment and screening effort.

Published
2014

19. Reply to Jacob and Colebunders

Author

Ellenberg, Susan S., Keusch, Gerald T., Babiker, Abdel G., Edwards, Kathryn M., Lewis, Roger J., Lundgren, Jens D., Wells, Charles D., Wabwire-Mangen, Fred, and McAdam, Keith P. W. J.

Published
2018

27. Monitoring Multiple U.S. Government–Supported Covid-19 Vaccine Trials

Author

Hunsberger, Sally, primary, Ellenberg, Susan S., additional, Joffe, Steven, additional, Babiker, Abdel, additional, Fix, Alan, additional, Griffin, Marie R., additional, Kalil, Jorge, additional, Levine, Myron M., additional, Makgoba, Malegapuru W., additional, Moore, Reneé H., additional, Tsiatis, Anastasios A., additional, and Whitley, Richard, additional

Published
2023
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32. Effect of the CCR5 antagonist maraviroc on the occurrence of immune reconstitution inflammatory syndrome in HIV (CADIRIS): a double-blind, randomised, placebo-controlled trial

Author

Sierra-Madero, Juan G, Ellenberg, Susan S, Rassool, Mohammed S, Tierney, Ann, Belaunzarán-Zamudio, Pablo F, López-Martínez, Alondra, Piñeirúa-Menéndez, Alicia, Montaner, Luis J, Azzoni, Livio, Benítez, César Rivera, Sereti, Irini, Andrade-Villanueva, Jaime, Mosqueda- Gómez, Juan L, Rodriguez, Benigno, Sanne, Ian, and Lederman, Michael M

Published
2014
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33. A platform trial design for preventive vaccines against Marburg virus and other emerging infectious disease threats

Author

Longini, Ira M, primary, Yang, Yang, additional, Fleming, Thomas R, additional, Muñoz-Fontela, César, additional, Wang, Rui, additional, Ellenberg, Susan S, additional, Qian, George, additional, Halloran, M Elizabeth, additional, Nason, Martha, additional, Gruttola, Victor De, additional, Mulangu, Sabue, additional, Huang, Yunda, additional, Donnelly, Christl A, additional, and Henao Restrepo, Ana-Maria, additional

Published
2022
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39. Adverse cardiovascular events and mortality in men during testosterone treatment: an individual patient and aggregate data meta-analysis

Author

Hudson, Jemma, primary, Cruickshank, Moira, additional, Quinton, Richard, additional, Aucott, Lorna, additional, Aceves-Martins, Magaly, additional, Gillies, Katie, additional, Bhasin, Shalender, additional, Snyder, Peter J, additional, Ellenberg, Susan S, additional, Grossmann, Mathis, additional, Travison, Thomas G, additional, Gianatti, Emily J, additional, van der Schouw, Yvonne T, additional, Emmelot-Vonk, Marielle H, additional, Giltay, Erik J, additional, Hackett, Geoff, additional, Ramachandran, Sudarshan, additional, Svartberg, Johan, additional, Hildreth, Kerry L, additional, Groti Antonic, Kristina, additional, Brock, Gerald B, additional, Tenover, J Lisa, additional, Tan, Hui Meng, additional, Kong, Christopher Ho Chee, additional, Tan, Wei Shen, additional, Marks, Leonard S, additional, Ross, Richard J, additional, Schwartz, Robert S, additional, Manson, Paul, additional, Roberts, Stephen, additional, Andersen, Marianne Skovsager, additional, Magnussen, Line Velling, additional, Hernández, Rodolfo, additional, Oliver, Nick, additional, Wu, Frederick, additional, Dhillo, Waljit S, additional, Bhattacharya, Siladitya, additional, Brazzelli, Miriam, additional, and Jayasena, Channa N, additional

Published
2022
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41. Improving the Approach to Defining, Classifying, Reporting and Monitoring Adverse Events in Seriously Ill Older Adults: Recommendations from a Multi-stakeholder Convening

Author

Baim-Lance, Abigail, primary, Ferreira, Katelyn B., additional, Cohen, Harvey Jay, additional, Ellenberg, Susan S., additional, Kuchel, George A., additional, Ritchie, Christine, additional, Sachs, Greg A., additional, Kitzman, Dalane, additional, Morrison, R. Sean, additional, and Siu, Albert, additional

Published
2022
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43. Testosterone Treatment and Cognitive Function in Older Men With Low Testosterone and Age-Associated Memory Impairment

Author

Resnick, Susan M., Matsumoto, Alvin M., Stephens-Shields, Alisa J., Ellenberg, Susan S., Gill, Thomas M., Shumaker, Sally A., Pleasants, Debbie D., Barrett-Connor, Elizabeth, Bhasin, Shalender, Cauley, Jane A., Cella, David, Crandall, Jill P., Cunningham, Glenn R., Ensrud, Kristine E., Farrar, John T., Lewis, Cora E., Molitch, Mark E., Pahor, Marco, Swerdloff, Ronald S., Cifelli, Denise, Anton, Stephen, Basaria, Shehzad, Diem, Susan J., Wang, Christina, Hou, Xiaoling, and Snyder, Peter J.

Published
2017
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44. Monitoring Multiple U.S. Government-Supported Covid-19 Vaccine Trials.

Author

Sacks, Chana A., Hunsberger, Sally, Ellenberg, Susan S., Joffe, Steven, Babiker, Abdel, Fix, Alan, Griffin, Marie R., Kalil, Jorge, Levine, Myron M., Makgoba, Malegapuru W., Moore, Reneé H., Tsiatis, Anastasios A., and Whitley, Richard

Subjects
CLINICAL trials, COVID-19 vaccines, VACCINE development, GOVERNMENT agencies, PATIENT safety
Abstract

Operation Warp Speed was a partnership created to accelerate the development of Covid-19 vaccines. The National Institutes of Health oversaw one data and safety monitoring board to review/monitor all Operation Warp Speed trials. This article describes the challenges faced in monitoring these trials and provides ideas for future similar endeavors. [ABSTRACT FROM AUTHOR]

Published
2023
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46. Survival Analysis in the Regulatory Setting

Author

Ellenberg, Susan S., Siegel, Jay P., Bickel, P., editor, Diggle, P., editor, Fienberg, S., editor, Krickeberg, K., editor, Olkin, I., editor, Wermuth, N., editor, Zeger, S., editor, Lin, D. Y., editor, and Fleming, T. R., editor

Published
1997
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47. Spinal Anesthesia or General Anesthesia for Hip Surgery in Older Adults

Author

Neuman, Mark D., primary, Feng, Rui, additional, Carson, Jeffrey L., additional, Gaskins, Lakisha J., additional, Dillane, Derek, additional, Sessler, Daniel I., additional, Sieber, Frederick, additional, Magaziner, Jay, additional, Marcantonio, Edward R., additional, Mehta, Samir, additional, Menio, Diane, additional, Ayad, Sabry, additional, Stone, Trevor, additional, Papp, Steven, additional, Schwenk, Eric S., additional, Elkassabany, Nabil, additional, Marshall, Mitchell, additional, Jaffe, J. Douglas, additional, Luke, Charles, additional, Sharma, Balram, additional, Azim, Syed, additional, Hymes, Robert A., additional, Chin, Ki-Jinn, additional, Sheppard, Richard, additional, Perlman, Barry, additional, Sappenfield, Joshua, additional, Hauck, Ellen, additional, Hoeft, Mark A., additional, Giska, Mark, additional, Ranganath, Yatish, additional, Tedore, Tiffany, additional, Choi, Stephen, additional, Li, Jinlei, additional, Kwofie, M. Kwesi, additional, Nader, Antoun, additional, Sanders, Robert D., additional, Allen, Brian F.S., additional, Vlassakov, Kamen, additional, Kates, Stephen, additional, Fleisher, Lee A., additional, Dattilo, James, additional, Tierney, Ann, additional, Stephens-Shields, Alisa J., additional, and Ellenberg, Susan S., additional

Published
2021
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48. Effects of Testosterone Treatment in Older Men

Author

Snyder, Peter J., Bhasin, Shalender, Cunningham, Glenn R., Matsumoto, Alvin M., Stephens-Shields, Alisa J., Cauley, Jane A., Gill, Thomas M., Barrett-Connor, Elizabeth, Swerdloff, Ronald S., Wang, Christina, Ensrud, Kristine E., Lewis, Cora E., Farrar, John T., Cella, David, Rosen, Raymond C., Pahor, Marco, Crandall, Jill P., Molitch, Mark E., Cifelli, Denise, Dougar, Darlene, Fluharty, Laura, Resnick, Susan M., Storer, Thomas W., Anton, Stephen, Basaria, Shehzad, Diem, Susan J., Hou, Xiaoling, Mohler, Emile R., III, Parsons, J. Kellogg, Wenger, Nanette K., Zeldow, Bret, Landis, J. Richard, and Ellenberg, Susan S.

Published
2016
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49. Prognosis for Spontaneous Resolution of OSA in Children

Author

Chervin, Ronald D., Ellenberg, Susan S., Hou, Xiaoling, Marcus, Carole L., Garetz, Susan L., Katz, Eliot S., Hodges, Elise K., Mitchell, Ron B., Jones, Dwight T., Arens, Raanan, Amin, Raouf, Redline, Susan, Rosen, Carol L., Katz, Eliot, Ware, Janice, Jones, Dwight, Redline, Susan, Wang, Rui, Mitchell, Ron, Paruthi, Shalini, Snyder, Karen, Marcus, Carole, Thomas, Nina H., Elden, Lisa, Amin, Raouf, Beebe, Dean, Willging, Paul, Arens, Raanan, Muzumdar, Hiren, Harris, Shelby, Rosen, Carol, Taylor, H. Gerry, Sprecher, Robert, Arnold, James, Gozal, David, Chervin, Ronald, Garetz, Susan, Giordani, Bruno, Hoban, Tim, Ellenberg, Susan, Moore, Reneé H., and Lacy, Kim

Published
2015
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