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1. Odanacatib for the treatment of postmenopausal osteoporosis: results of the LOFT multicentre, randomised, double-blind, placebo-controlled trial and LOFT Extension study

Author

Mautalén, Carlos Alfredo, Man, Zulema, Zanchetta, Jose Ruben, Magaril, Clelia Haydee, Sambrook, Philip, Reginster, Jean-Yves, Geusens, Piet, Goemaere, Stefan, Albergaria, Ben Hur, Zerbini, Cristiano Augusto de Freitas, Castro, Marise Lazaretti, Gregorio, Luiz Henrique, Stoilov, Rumen, Borissova, Anna-Maria I, Hristozov, Kiril Hristov, Temelkova, Nataliya L, Daskalova, Ivona Kirilova, Kuzmanova, Stefka Ivanova, Yaneva-Bichovska, Daniela, Batalov, Anastas Zgurov, Riedemann, Pablo, Rodriguez Portales, José Adolfo, Tang, Hai, Zhu, hanmin, Zhang, Zhenlin, Chao, Aijun, Hu, Yali, Liu, Zhiming, Lu, Juming, Qiu, Mingcai, Gao, Xin, Zhang, Shaofen, Xu, Ling, Xia, Weibo, Liao, Eryuan, Yang, Wenying, Wu, Wen, Dai, Kerong, Hu, Renming, Jaller, Juan Jose, Cabal, Francisco, Molina, José Fernando, Cure Cure, Carlos A, Yupanqui-Lozno, Hernan, Chalem, Philippe, Londono, John, Abello, Mauricio, Tobias, Edgardo D, Otero, William, Nikolic, Tatjana, Miskic, Blazenka, Stepan, Jan, Vyskocil, Vaclav, Novosad, Libor, Slesinger, Jan, Novosad, Pavel, Vlckova, Erika, Bortlik, Ladislav, Dokoupilova, Eva, Hala, Tomas, Jensen, Jens-Erik Beck, Brixen, Kim Torsten, Langdahl, Bente Lomholt, Schwarz, Peter, Eskildsen, Peter Claes, Eiken, Pia Agnete, Hermann, Anne Pernille, Gram, Jeppe, Schou, Maiken Brix, Alexandersen, Peter, Nedergaard, Bettina, Mejía, Dolores Magdalena, Estrella De Henriquez, Lourdes, Páez, Norka, Velazco, Casimiro, Valter, Ivo, Vahula, Kadri-Liina, Kull, Ingrid, Maasalu, Katre, Chapurlat, Roland, Fardellone, Patrice, Benhamou, Claude Laurent, Roux, Christian, Weryha, Georges, Herkt, Volkmar, Martz, Rene, Nischik, Ruth, Spieler, Wolfgang, Contzen, Christel, Felsenberg, Dieter, Frieling, Isolde, Frahm, Eike, Briones, Henry, Sandoval, Boris, Barrios, Patricia, García, Abraham, Avendaño, Carlos, González, Magdalena, Guerra, Jeremías, Tuna, Maria, Díaz, Olga Marina, Samayoa, Eduardo, López, Edgar, Barrera, José Raúl, Palencia, Mainor, Cifuentes, Mayra, Alvarado, Georgina, López, Miriam, Chavez, Nilmo, Haase, Franklin, Rivera, Ruddy, González, Claudio, Tan, Kathryn, Leung, Ping Chung, Mandalam, Sheshadri, Pitale, Shailesh Umakant, Bantwal, Ganapathi, Ammini, Ariachery Chinamma, Shaikh, Shehla Sajid Akhta, Kanakatte Mylariah, Prasanna Kumar, Dharmalingam, Mala, Mukhopadhyay, Satinath, Jain, Arpit, Singh, Parminder, Shetty, Naresh, Sathyanarayana, Srikanta Shamanna, Shah, Nalini, Chadha, Manoj Dharam, Bhandankar, Rajendra, Velayutham, Kumaravel, Marwah, Sudha, John, Mathew, Sahay, Rakesh Kumar, Adami, Silvano, Nuti, Ranuccio, Bianchi, Gerolamo, Brandi, Maria Luisa, Minisola, Salvatore, Fiore, Carmelo Erio, Rubinacci, Alessandro, Miyajima, Hisayuki, Yamane, Hiroo, Nakatani, Yuji, Okamoto, Sumiaki, Kuroda, Koji, Fujimori, Motoaki, Itabashi, Akira, Katayama, Kuniaki, Nakajo, Satoru, Somekawa, Yoshiaki, Ohsawa, Yoshimitsu, Tajima, Wataru, Mizuno, Katsunori, Mori, Shigeru, Kanabuchi, Takato, Hashizume, Hiroyuki, Oka, Nobuyuki, Hamada, Kazutoshi, Yamaguchi, Motoi, Hirahara, Fumiki, Atobe, Masaaki, Ohtake, Yoshiharu, Ichikawa, Shuichi, Onishi, Tomoyuki, Matsumoto, Kou, Nakamura, Tetsuro, Shirasawa, Eishi, Katayama, Ko, Takahashi, Mitsugu, Oguma, Tadanori, Matsui, Hideo, Katoh, Yoshiharu, Shigenobu, Keiichi, Onishi, Tsutomu, Shibukawa, Masato, Ikeda, Satoshi, Osaka, Kazuhiro, Kanda, Ryosuke, Inobe, Yoshito, Shigenobu, Masaharu, Hasegawa, Morimasa, Yamaji, Tetsuo, Miyazaki, Yu, Ito, Takayasu, Nakamura, Eisuke, Nagai, Shinji, Lim, Sung-Kil, Chung, Yoon-Sok, Shin, Chan-Soo, Min, Yong-Ki, Kim, Ghi Su, Yoon, Hyun Koo, Kang, Moo-Il, Yang, Kyu-Hyun, Park, Hyoung Moo, Kim, In Joo, Chung, Dong Jin, Chung, Ho Yeon, Jaundzeikare, Sandra, Andersone, Dace, Medne, Agita, Yaghi, Yasser, Alekna, Vidmantas, Kasiulevicius, Vytautas, Purtokaite - Labutiniene, Irina, Krasauskiene, Aurelija, Varanaviciene, Jurate, Basijokiene, Vida, Abraitiene, Agne, Radzeviciene, Lina, Walliser, Jesus, García Hernández, Pedro Alberto, Araujo, Maria Frida, Avila Armengol, Hilario Ernesto, De la Peña, Pilar, Tamayo, Juan, Zazueta, Beatriz, Cons, Fidencio, Gilchrist, Nigel Leslie, Reid, Ian Reginald, Leikis, Robert, Jones, Peter, Singh, Joe Gragrath Pradeep, Halse, Johan Inge, Syversen, Unni, Høivik, Hans Olav, Øfjord, Erik Snorre, Gulseth, Hans Christian, Elle, Sigbjørn, Norheim, Paal Dag, Calvo Quiroz, Armando A., Cesar Augusto, Pastor A., León Portocarrero, Manuel Gustavo, Vidal Neira, Luis Fernando, Chavez, Jose, Garro Barrera, Boris, Kuroiwa Sampei, Rita, Luis Fernando, Bellatín V., Oquelis Cabredo, Rogger, Castillo, Sonia, Morales, Agustin Miguel G, Tan, Perry Pua, Leagogo, Liberato Antonio C, Jr., Wang, Edward HM, Li-Yu, Julie T, Sawicki, Andrzej Z, Stasiuk, Barbara, Kania, Grzegorz, Lorenc, Roman, Sidorowicz-Bialynicka, Anna, Szczepanski, Leszek, Franek, Edward, Filip, Rafal, Sekula, Jan, Blicharski, Tomasz, Leszczynski, Piotr, Sewerynek, Ewa, Miazgowski, Tomasz, Milewicz, Andrzej, Dabrowska, Magda, Romaszko, Jerzy, Pluskiewicz, Wojciech, Wojnowski, Lukasz, Codreanu, Catalin, Bolosiu, Horatiu, Ionescu, Ruxandra, Zosin, Ioana, Macovei, Liviu, Bojinca, Mihai, Radulescu, Florin, Pop, Simona, Sarbu, Adrian, Benevolenskaya, Lidia I, Nasonov, Evgeny L, Rozhinskaya, Lyudmila Ya, Oganov, Raphael G, Rodionova, Svetlana S, Shlyakhto, Eugeny Vladimirovich, Trofimov, Vasiliy, Zotkin, Eugeny G, Zazerskaya, Irina E, Grineva, Elena N, Ershova, Olga, Lesnyak, Olga, Ostroumova, Olga D, Malichenko, Svetlana B, Pikhlak, Eduard G, Pilyaev, Valery G, Raskina, Tatiana, Zonova, Elena V, Shirinsky, Valery S, Dimic, Aleksandar N, Cobeljic, Goran, Vujovic, Svetlana, Ellis, Graham Charlston, Lipschitz, Stanley, De Villiers, Tobias Johannes, De Weerd, Albert Jan, Vally, Tasneem, Trinder, Yvonne, Coetsee, Jacobus Ludewikus, Davis, Charles Pierre, Nayiager, Savithree, Hough, Frans Stephanus, Oelofse, Louis F, van der Walt, Eugene, Lombaard, Johannes Jurgens, Blignaut, Suzanne, Govind, Uttam, Fouche, Leon Frederik, Kruger, Dawid Stephanus, Dalmeyer, Johannes Paul, Ferreira, Mada M, Escudero-Contreras, Alejandro, Muñoz Torres, Manuel, Hawkins Carranza, Federico, Perez Castrillon, Jose Luis, García Meijide, Juan Antonio, Jodar Gimeno, Esteban, Palacios Gil-Antuñana, Santiago, de Teresa Parreno, Luis, Martín Mola, Emilio, Alvarez Sanchez, Carmen, Lippuner, Kurt, Tsai, Keh-Sung, Tu, Shih-Te, Chen, Jung-Fu, Lee, Oscar Kuang-Sheng, Hsu, Wen-Wei, Grygorieva, Natalia Viktorivna, Povoroznyuk, Vladyslav Volodymyrovych, Korzh, Mykola Oleksiiovych, Loskutov, Oleksandr Levgeniiovych, Chukov, Andriy Borysovych, Sarmiento, Rex, Thomas, Hawys, Donnachie, Hugh, Pavel-Knox, Irina, Shaw, Hilary, Hassanin, Hana, Abdulhakim, Essam Eldin Ahmed, Savani, Naren, Bachmann, Gloria A, Barrett-Connor, Elizabeth, Binkley, Neil C, Bone, Henry G, Brandon, Donald M, Checketts, Darin David, Fraser, Neil J, Watts, Nelson B, Geller, Steven A, Gimbel, Joseph S, Greenwald, Maria White, Holt, Peter A, Johnston, Cyrus Conrad, Fang, Chien, Kiel, Douglas P, Klashman, David J, Lewiecki, E. Michael, Lowenstein, Mitchell B, McClung, Michael Roy, Nattrass, Susan M, Odio, Alberto, Levengood, Julie, Romaguera, Josefina, Saag, Kenneth G, Sebai, Mohamed Bassam, Snyder, Brian, Kutner, Mark Eliot, Streja, Dan, Schwartz, Elliott P, Christiansen, Mark G, McClung, Michael R, O'Donoghue, Michelle L, Papapoulos, Socrates E, Bone, Henry, Langdahl, Bente, Reid, Ian R, Cavallari, Ilaria, Bonaca, Marc P, Wiviott, Stephen D, de Villiers, Tobias, Ling, Xu, Nakamura, Toshitaka, Rodriguez-Portales, Jose Adolfo, Zanchetta, José, Zerbini, Cristiano A F, Park, Jeong-Gun, Im, KyungAh, Cange, Abby, Grip, Laura T, Heyden, Norman, DaSilva, Carolyn, Cohn, Dosinda, Massaad, Rachid, Scott, Boyd B, Verbruggen, Nadia, Gurner, Deborah, Miller, Deborah L, Blair, Micki L, Polis, Adam B, Stoch, S Aubrey, Santora, Arthur, Lombardi, Antonio, Leung, Albert T, Kaufman, Keith D, and Sabatine, Marc S

Published
2019
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2. Relationship of Weight, Height, and Body Mass Index With Fracture Risk at Different Sites in Postmenopausal Women: The Global Longitudinal Study of Osteoporosis in Women (GLOW)

Author

Compston, Juliet E, Flahive, Julie, Hosmer, David W, Watts, Nelson B, Siris, Ethel S, Silverman, Stuart, Saag, Kenneth G, Roux, Christian, Rossini, Maurizio, Pfeilschifter, Johannes, Nieves, Jeri W, Netelenbos, J Coen, March, Lyn, LaCroix, Andrea Z, Hooven, Frederick H, Greenspan, Susan L, Gehlbach, Stephen H, Díez‐Pérez, Adolfo, Cooper, Cyrus, Chapurlat, Roland D, Boonen, Steven, Anderson, Frederick A, Adami, Silvano, Adachi, Jonathan D, and Investigators, for the GLOW

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Aging, Nutrition, Obesity, Clinical Research, Osteoporosis, Prevention, Evaluation of treatments and therapeutic interventions, 6.7 Physical, Musculoskeletal, Age Factors, Aged, Body Mass Index, Body Weight, Bone and Bones, Female, Follow-Up Studies, Fractures, Bone, Humans, Middle Aged, Models, Biological, Postmenopause, Risk Factors, GLOW Investigators, BMI, FRACTURES, OBESITY, OSTEOPOROSIS, POSTMENOPAUSAL WOMEN, Biological Sciences, Engineering, Medical and Health Sciences, Anatomy & Morphology, Biological sciences, Biomedical and clinical sciences
Abstract

Low body mass index (BMI) is a well-established risk factor for fracture in postmenopausal women. Height and obesity have also been associated with increased fracture risk at some sites. We investigated the relationships of weight, BMI, and height with incident clinical fracture in a practice-based cohort of postmenopausal women participating in the Global Longitudinal study of Osteoporosis in Women (GLOW). Data were collected at baseline and at 1, 2, and 3 years. For hip, spine, wrist, pelvis, rib, upper arm/shoulder, clavicle, ankle, lower leg, and upper leg fractures, we modeled the time to incident self-reported fracture over a 3-year period using the Cox proportional hazards model and fitted the best linear or nonlinear models containing height, weight, and BMI. Of 52,939 women, 3628 (6.9%) reported an incident clinical fracture during the 3-year follow-up period. Linear BMI showed a significant inverse association with hip, clinical spine, and wrist fractures: adjusted hazard ratios (HRs) (95% confidence intervals [CIs]) per increase of 5 kg/m(2) were 0.80 (0.71-0.90), 0.83 (0.76-0.92), and 0.88 (0.83-0.94), respectively (all p

Published
2014

3. Risk Factors for Treatment Failure With Antiosteoporosis Medication: The Global Longitudinal Study of Osteoporosis in Women (GLOW)

Author

Díez‐Pérez, Adolfo, Adachi, Jonathan D, Adami, Silvano, Anderson, Frederick A, Boonen, Steven, Chapurlat, Roland, Compston, Juliet E, Cooper, Cyrus, Gehlbach, Stephen H, Greenspan, Susan L, Hooven, Frederick H, LaCroix, Andrea Z, Nieves, Jeri W, Netelenbos, J Coen, Pfeilschifter, Johannes, Rossini, Maurizio, Roux, Christian, Saag, Kenneth G, Silverman, Stuart, Siris, Ethel S, Wyman, Allison, Rushton‐Smith, Sophie K, Watts, Nelson B, and Investigators, for the Global Longitudinal Study of Osteoporosis in Women

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Aging, Clinical Research, Prevention, Osteoporosis, Injuries and accidents, Good Health and Well Being, Accidental Falls, Aged, Bone Density Conservation Agents, Comorbidity, Diphosphonates, Female, Fractures, Bone, Humans, Longitudinal Studies, Middle Aged, Osteoporosis, Postmenopausal, Prospective Studies, Risk Factors, Treatment Failure, TREATMENT FAILURE, ANTIRESORPTIVE THERAPY, RISK FACTORS, OSTEOPOROSIS TREATMENT, Global Longitudinal Study of Osteoporosis in Women (GLOW) Investigators, Biological Sciences, Engineering, Medical and Health Sciences, Anatomy & Morphology, Biological sciences, Biomedical and clinical sciences
Abstract

Antiosteoporosis medication (AOM) does not abolish fracture risk, and some individuals experience multiple fractures while on treatment. Therefore, criteria for treatment failure have recently been defined. Using data from the Global Longitudinal Study of Osteoporosis in Women (GLOW), we analyzed risk factors for treatment failure, defined as sustaining two or more fractures while on AOM. GLOW is a prospective, observational cohort study of women aged ≥55 years sampled from primary care practices in 10 countries. Self-administered questionnaires collected data on patient characteristics, fracture risk factors, previous fractures, AOM use, and health status. Data were analyzed from women who used the same class of AOM continuously over 3 survey years and had data available on fracture occurrence. Multivariable logistic regression was used to identify independent predictors of treatment failure. Data from 26,918 women were available, of whom 5550 were on AOM. During follow-up, 73 of 5550 women in the AOM group (1.3%) and 123 of 21,368 in the non-AOM group (0.6%) reported occurrence of two or more fractures. The following variables were associated with treatment failure: lower Short Form 36 Health Survey (SF-36) score (physical function and vitality) at baseline, higher Fracture Risk Assessment Tool (FRAX) score, falls in the past 12 months, selected comorbid conditions, prior fracture, current use of glucocorticoids, need of arms to assist to standing, and unexplained weight loss ≥10 lb (≥4.5 kg). Three variables remained predictive of treatment failure after multivariable analysis: worse SF-36 vitality score (odds ratio [OR] per 10-point increase, 0.85; 95% confidence interval [CI], 0.76-0.95; p = 0.004); two or more falls in the past year (OR, 2.40; 95% CI, 1.34-4.29; p = 0.011), and prior fracture (OR, 2.93; 95% CI, 1.81-4.75; p

Published
2014

4. When, Where and How Osteoporosis-Associated Fractures Occur: An Analysis from the Global Longitudinal Study of Osteoporosis in Women (GLOW)

Author

Costa, Aline G, Wyman, Allison, Siris, Ethel S, Watts, Nelson B, Silverman, Stuart, Saag, Kenneth G, Roux, Christian, Rossini, Maurizio, Pfeilschifter, Johannes, Nieves, Jeri W, Netelenbos, J Coen, March, Lyn, LaCroix, Andrea Z, Hooven, Frederick H, Greenspan, Susan L, Gehlbach, Stephen H, Díez-Pérez, Adolfo, Cooper, Cyrus, Compston, Juliet E, Chapurlat, Roland D, Boonen, Steven, Anderson, Frederick A, Adachi, Jonathan D, and Adami, Silvano

Subjects
Biomedical and Clinical Sciences, Public Health, Clinical Sciences, Health Sciences, Reproductive Medicine, Osteoporosis, Aging, Physical Injury - Accidents and Adverse Effects, Behavioral and Social Science, Musculoskeletal, Injuries and accidents, Accidental Falls, Age Factors, Aged, Aged, 80 and over, Hip Fractures, Humans, Male, Middle Aged, Osteoporosis, Postmenopausal, Retrospective Studies, Seasons, General Science & Technology
Abstract

ObjectiveTo examine when, where and how fractures occur in postmenopausal women.MethodsWe analyzed data from the Global Longitudinal Study of Osteoporosis in Women (GLOW), including women aged ≥55 years from the United States of America, Canada, Australia and seven European countries. Women completed questionnaires including fracture data at baseline and years 1, 2 and 3.ResultsAmong 60,393 postmenopausal women, 4122 incident fractures were reported (86% non-hip, non-vertebral [NHNV], 8% presumably clinical vertebral and 6% hip). Hip fractures were more likely to occur in spring, with little seasonal variation for NHNV or spine fractures. Hip fractures occurred equally inside or outside the home, whereas 65% of NHNV fractures occurred outside and 61% of vertebral fractures occurred inside the home. Falls preceded 68-86% of NHNV and 68-83% of hip fractures among women aged ≤64 to ≥85 years, increasing with age. About 45% of vertebral fractures were associated with falls in all age groups except those ≥85 years, when only 24% occurred after falling.ConclusionIn this multi-national cohort, fractures occurred throughout the year, with only hip fracture having a seasonal variation, with a higher proportion in spring. Hip fractures occurred equally within and outside the home, spine fractures more often in the home, and NHNV fractures outside the home. Falls were a proximate cause of most hip and NHNV fractures. Postmenopausal women at risk for fracture need counseling about reducing potentially modifiable fracture risk factors, particularly falls both inside and outside the home and during all seasons of the year.

Published
2013

5. Predictors of Treatment with Osteoporosis Medications After Recent Fragility Fractures in a Multinational Cohort of Postmenopausal Women

Author

Greenspan, Susan L, Wyman, Allison, Hooven, Frederick H, Adami, Silvano, Gehlbach, Stephen, Anderson, Frederick A, Boone, Steven, Lacroix, Andrea Z, Lindsay, Robert, Netelenbos, J Coen, Pfeilschifter, Johannes, Silverman, Stuart, Siris, Ethel S, and Watts, Nelson B

Subjects
Reproductive Medicine, Biomedical and Clinical Sciences, Clinical Sciences, Estrogen, Aging, Osteoporosis, Clinical Research, Musculoskeletal, Injuries and accidents, Aged, Chi-Square Distribution, Female, Follow-Up Studies, Fractures, Bone, Humans, Middle Aged, Osteoporosis, Postmenopausal, Prospective Studies, Regression Analysis, Risk Factors, Surveys and Questionnaires, osteoporosis, fracture, osteoporosis treatment, Medical and Health Sciences, Geriatrics, Biomedical and clinical sciences, Health sciences, Psychology
Abstract

ObjectivesTo determine the proportion of untreated women who reported receiving treatment after incident fracture and to identify factors that predict treatment across an international spectrum of individuals.DesignProspective observational study. Self-administered questionnaires were mailed at baseline and 1 year.SettingMultinational cohort of noninstitutionalized women recruited from 723 primary physician practices in 10 countries.ParticipantsSixty thousand three hundred ninety-three postmenopausal women aged 55 and older were recruited with a 2:1 oversampling of women aged 65 and older.MeasurementsData collected included participant demographics, medical history, fracture occurrence, medications, and risk factors for fracture. Anti-osteoporosis medications (AOMs) included estrogen, selective estrogen receptor modulators, bisphosphonates, calcitonin, parathyroid hormone, and strontium.ResultsAfter the first year of follow-up, 1,075 women reported an incident fracture. Of these, 17% had started AOM, including 15% of those with a single fracture and 35% with multiple fractures. Predictors of treatment included baseline calcium use (P = .01), baseline diagnosis of osteoporosis (P < .001), and fracture type (P < .001). In multivariable analysis, women taking calcium supplements at baseline (odds ratio (OR) = 1.67) and with a baseline diagnosis of osteoporosis (OR = 2.55) were more likely to be taking AOM. Hip fracture (OR = 2.61), spine fracture (OR = 6.61), and multiple fractures (OR = 3.79) were associated with AOM treatment. Age, global region, and use of high-risk medications were not associated with treatment.ConclusionMore than 80% of older women with new fractures were not treated, despite the availability of AOM. Important factors associated with treatment in this international cohort included diagnosis of osteoporosis before the incident fracture, spine fracture, and to a lesser degree, hip fracture.

Published
2012

6. Relationship between bone mineral density changes with denosumab treatment and risk reduction for vertebral and nonvertebral fractures

Author

Austin, Matthew, Yang, Yu‐Ching, Vittinghoff, Eric, Adami, Silvano, Boonen, Steven, Bauer, Douglas C, Bianchi, Gerolamo, Bolognese, Michael A, Christiansen, Claus, Eastell, Richard, Grauer, Andreas, Hawkins, Federico, Kendler, David L, Oliveri, Beatriz, McClung, Michael R, Reid, Ian R, Siris, Ethel S, Zanchetta, Jose, Zerbini, Cristiano AF, Libanati, Cesar, Cummings, Steven R, and Trial, for the FREEDOM

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Clinical Research, Osteoporosis, Physical Injury - Accidents and Adverse Effects, Musculoskeletal, Absorptiometry, Photon, Aged, Aged, 80 and over, Antibodies, Monoclonal, Antibodies, Monoclonal, Humanized, Bone Density, Bone Density Conservation Agents, Denosumab, Double-Blind Method, Female, Fractures, Bone, Humans, Middle Aged, Placebos, Risk Reduction Behavior, Spinal Fractures, DENOSUMAB, BONE MINERAL DENSITY, FRACTURE, SURROGATE, PERCENT OF TREATMENT EFFECT EXPLAINED, FREEDOM Trial, Biological Sciences, Engineering, Medical and Health Sciences, Anatomy & Morphology, Biological sciences, Biomedical and clinical sciences
Abstract

Dual-energy X-ray absorptiometric bone mineral density (DXA BMD) is a strong predictor of fracture risk in untreated patients. However, previous patient-level studies suggest that BMD changes explain little of the fracture risk reduction observed with osteoporosis treatment. We investigated the relevance of DXA BMD changes as a predictor for fracture risk reduction using data from the FREEDOM trial, which randomly assigned placebo or denosumab 60 mg every 6 months to 7808 women aged 60 to 90 years with a spine or total hip BMD T-score < -2.5 and not < -4.0. We took a standard approach to estimate the percent of treatment effect explained using percent changes in BMD at a single visit (months 12, 24, or 36). We also applied a novel approach using estimated percent changes in BMD from baseline at the time of fracture occurrence (time-dependent models). Denosumab significantly increased total hip BMD by 3.2%, 4.4%, and 5.0% at 12, 24, and 36 months, respectively. Denosumab decreased the risk of new vertebral fractures by 68% (p < 0.0001) and nonvertebral fracture by 20% (p = 0.01) over 36 months. Regardless of the method used, the change in total hip BMD explained a considerable proportion of the effect of denosumab in reducing new or worsening vertebral fracture risk (35% [95% confidence interval (CI): 20%-61%] and 51% [95% CI: 39%-66%] accounted for by percent change at month 36 and change in time-dependent BMD, respectively) and explained a considerable amount of the reduction in nonvertebral fracture risk (87% [95% CI: 35% - >100%] and 72% [95% CI: 24% - >100%], respectively). Previous patient-level studies may have underestimated the strength of the relationship between BMD change and the effect of treatment on fracture risk or this relationship may be unique to denosumab.

Published
2012

7. Regional differences in treatment for osteoporosis. The Global Longitudinal Study of Osteoporosis in Women (GLOW)

Author

Díez-Pérez, Adolfo, Hooven, Frederick H, Adachi, Jonathan D, Adami, Silvano, Anderson, Frederick A, Boonen, Steven, Chapurlat, Roland, Compston, Juliet E, Cooper, Cyrus, Delmas, Pierre, Greenspan, Susan L, LaCroix, Andrea Z, Lindsay, Robert, Netelenbos, J Coen, Pfeilschifter, Johannes, Roux, Christian, Saag, Kenneth G, Sambrook, Philip, Silverman, Stuart, Siris, Ethel S, Watts, Nelson B, Nika, Grigor, and Gehlbach, Stephen H

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Osteoporosis, Aging, Prevention, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Musculoskeletal, Aged, Australia, Bone Density Conservation Agents, Canada, Estrogen Replacement Therapy, Europe, Female, Fractures, Bone, Health Status, Humans, Longitudinal Studies, Middle Aged, Risk Factors, Surveys and Questionnaires, United States, Biological Sciences, Engineering, Medical and Health Sciences, Endocrinology & Metabolism, Clinical sciences
Abstract

PurposeTo determine if important geographic differences exist in treatment rates for osteoporosis and whether this variation can be explained by regional variation in risk factors.MethodsThe Global Longitudinal Study of Osteoporosis in Women is an observational study of women ≥55 years sampled from primary care practices in 10 countries. Self-administered questionnaires were used to collect data on patient characteristics, risk factors for fracture, previous fractures, anti-osteoporosis medication, and health status.ResultsAmong 58,009 women, current anti-osteoporosis medication use was lowest in Northern Europe (16%) and highest in U.S.A. and Australia (32%). Between 48% (U.S.A., Southern Europe) and 68% (Northern Europe) of women aged ≥65 years with a history of spine or hip fracture since age 45 were untreated. Among women with osteoporosis, the percentage of treated cases was lowest in Europe (45-52% versus 62-65% elsewhere). Women with osteopenia and no other risk factors were treated with anti-osteoporosis medication most frequently in U.S.A. (31%) and Canada (31%), and least frequently in Southern Europe (12%), Northern Europe (13%), and Australia (16%). After adjusting for risk factors, U.S. women were threefold as likely to be treated with anti-osteoporosis medication as Northern European women (odds ratio 2.8; 95% confidence interval 2.5-3.1) and 1.5 times as likely to be treated as Southern European women (1.5, 1.4-1.6). Up to half of women reporting previous hip or spine fracture did not receive treatment.ConclusionsThe likelihood of being treated for osteoporosis differed between regions, and cannot be explained by variation in risk factors. Many women at risk of fracture do not receive prophylaxis.

Published
2011

8. Impact of Prevalent Fractures on Quality of Life: Baseline Results From the Global Longitudinal Study of Osteoporosis in Women

Author

Adachi, Jonathan D, Adami, Silvano, Gehlbach, Stephen, Anderson, Frederick A, Boonen, Steven, Chapurlat, Roland D, Compston, Juliet E, Cooper, Cyrus, Delmas, Pierre, Díez-Pérez, Adolfo, Greenspan, Susan L, Hooven, Frederick H, LaCroix, Andrea Z, Lindsay, Robert, Netelenbos, J Coen, Wu, Olivia, Pfeilschifter, Johannes, Roux, Christian, Saag, Kenneth G, Sambrook, Philip N, Silverman, Stuart, Siris, Ethel S, Nika, Grigor, Watts, Nelson B, and Investigators, for the GLOW

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Arthritis, Clinical Research, Osteoporosis, Aging, Musculoskeletal, Good Health and Well Being, Age Factors, Aged, Europe, Female, Femoral Fractures, Fractures, Bone, Health Status, Hip Fractures, Humans, Linear Models, Longitudinal Studies, Middle Aged, Quality of Life, Spinal Fractures, GLOW Investigators, Medical and Health Sciences, Biomedical and clinical sciences
Abstract

ObjectiveTo examine several dimensions of health-related quality of life (HRQL) in postmenopausal women who report previous fractures, and to provide perspective by comparing these findings with those in other chronic conditions (diabetes, arthritis, lung disease).Patients and methodsFractures are a major cause of morbidity among older women. Few studies have examined HRQL in women who have had prior fractures and the effect of prior fracture location on HRQL. In this observational study of 57,141 postmenopausal women aged 55 years and older (enrollment from December 2007 to March 2009) from 17 study sites in 10 countries, HRQL was measured using the European Quality of Life 5 Dimensions Index (EQ-5D) and the health status, physical function, and vitality questions of the Medical Outcomes Study 36-Item Short Form Health Survey (SF-36).ResultsReductions in EQ-5D health-utility scores and SF-36-measured health status, physical function, and vitality were seen in association with 9 of 10 fracture locations. Spine, hip, and upper leg fractures resulted in the greatest reductions in quality of life (EQ-5D scores, 0.62, 0.64, and 0.61, respectively, vs 0.79 without prior fracture). Women with fractures at any of these 3 locations, as well as women with a history of multiple fractures (EQ-5D scores, 0.74 for 1 prior fracture, 0.68 for 2, and 0.58 for >/=3), had reductions in HRQL that were similar to or worse than those in women with other chronic diseases (0.67 for diabetes, 0.69 for arthritis, and 0.71 for lung disease).ConclusionPrevious fractures at a variety of bone locations, particularly spine, hip, and upper leg, or involving more than 1 location are associated with significant reductions in quality of life.

Published
2010

19. Adult-onset Still’s disease: an Italian multicentre retrospective observational study of manifestations and treatments in 245 patients

Author

Sfriso, Paolo, Priori, Roberta, Valesini, Guido, Rossi, Silvia, Montecucco, Carlo Maurizio, D’Ascanio, Anna, Carli, Linda, Bombardieri, Stefano, LaSelva, Gaetana, Iannone, Florenzo, Lapadula, Giovanni, Alivernini, Stefano, Ferraccioli, Gianfranco, Colaci, Michele, Ferri, Clodoveo, Iacono, Daniela, Valentini, Gabriele, Costa, Luisa, Scarpa, Raffaele, LoMonaco, Andrea, Bagnari, Valentina, Govoni, Marcello, Piazza, Ilaria, Adami, Silvano, Ciccia, Francesco, Triolo, Giovanni, Alessandri, Elisa, Cutolo, Maurizio, Cantarini, Luca, Galeazzi, Mauro, Ruscitti, Piero, Giacomelli, Roberto, Caso, Francesco, Galozzi, Paola, and Punzi, Leonardo

Published
2016
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24. Risedronate in children with osteogenesis imperfecta: a randomised, double-blind, placebo-controlled trial

Author

Bishop, Nick, Adami, Silvano, Ahmed, S Faisal, Antón, Jordi, Arundel, Paul, Burren, Christine P, Devogelaer, Jean-Pierre, Hangartner, Thomas, Hosszú, Eva, Lane, Joseph M, Lorenc, Roman, Mäkitie, Outi, Munns, Craig F, Paredes, Ana, Pavlov, Helene, Plotkin, Horacio, Raggio, Cathleen L, Reyes, Maria Loreto, Schoenau, Eckhard, Semler, Oliver, Sillence, David O, and Steiner, Robert D

Published
2013
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43. High rate of disease remission in moderate rheumatoid arthritis on etanercept therapy: data from GISEA, the Italian biologics register

Author

Iannone, Florenzo, Gremese, Elisa, Gallo, Gaia, Sarzi-Puttini, Piercarlo, Botsios, Costantino, Trotta, Francesco, Gasperini, Stefania, Galeazzi, Mauro, Adami, Silvano, Cantini, Fabrizio, Sebastiani, Marco, Gorla, Roberto, Marchesoni, Antonio, Giardina, AnnaRita, Foti, Rosario, Mele, Angiola, Bruschi, Eleonora, Bagnato, Gianluca, Erre, Gian Luca, Lapadula, Giovanni, and on behalf of GISEA (Gruppo Italiano Studio Early Arthritis)

Published
2014
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