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1. The use of denosumab in osteoporosis – an update on efficacy and drug safety

Author

Diab, Dima L. and Watts, Nelson B.

Abstract

ABSTRACTIntroductionDenosumab (Prolia) is a fully human monoclonal antibody against the receptor activator of the nuclear factor kappaB ligand. It is a potent antiresorptive agent that reduces osteoclastogenesis.Areas CoveredDenosumab has been shown to improve bone mineral density and reduce the incidence of new fractures in postmenopausal women and men. It is also used in the treatment of glucocorticoid-induced osteoporosis, as well as for the prevention of bone loss and reduction of fracture risk in men receiving androgen deprivation therapy for non-metastatic prostate cancer and women receiving adjuvant aromatase inhibitor therapy for breast cancer. Initial safety concerns included infections, cancer, skin reactions, cardiovascular disease, hypocalcemia, osteonecrosis of the jaw, and atypical femur fractures; however, further study and experience provide reassurance on these issues. Anecdotal reports have raised concerns about an increased risk of multiple vertebral fractures following discontinuation of denosumab.Expert OpinionAlthough bisphosphonates are often selected as initial therapy for osteoporosis, denosumab may be an appropriate initial therapy in patients at high risk for fracture, including older patients who have difficulty with the dosing requirements of oral bisphosphonates, as well as patients who are intolerant of, unresponsive to, or have contraindications to other therapies. Additional data is needed to address questions regarding treatment duration and discontinuation.

Published
2024
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2. Vitamin D for the Prevention of Disease: An Endocrine Society Clinical Practice Guideline.

Author

Demay, Marie B, Pittas, Anastassios G, Bikle, Daniel D, Diab, Dima L, Kiely, Mairead E, Lazaretti-Castro, Marise, Lips, Paul, Mitchell, Deborah M, Murad, M Hassan, Powers, Shelley, Rao, Sudhaker D, Scragg, Robert, Tayek, John A, Valent, Amy M, Walsh, Judith M E, and McCartney, Christopher R

Subjects
PREMATURE labor, PREECLAMPSIA, VITAMIN D, ENDOCRINE diseases, MEDICAL personnel, CHOLECALCIFEROL, PREVENTIVE medicine, OLANZAPINE
Abstract

Background Numerous studies demonstrate associations between serum concentrations of 25-hydroxyvitamin D (25[OH]D) and a variety of common disorders, including musculoskeletal, metabolic, cardiovascular, malignant, autoimmune, and infectious diseases. Although a causal link between serum 25(OH)D concentrations and many disorders has not been clearly established, these associations have led to widespread supplementation with vitamin D and increased laboratory testing for 25(OH)D in the general population. The benefit-risk ratio of this increase in vitamin D use is not clear, and the optimal vitamin D intake and the role of testing for 25(OH)D for disease prevention remain uncertain. Objective To develop clinical guidelines for the use of vitamin D (cholecalciferol [vitamin D3] or ergocalciferol [vitamin D2]) to lower the risk of disease in individuals without established indications for vitamin D treatment or 25(OH)D testing. Methods A multidisciplinary panel of clinical experts, along with experts in guideline methodology and systematic literature review, identified and prioritized 14 clinically relevant questions related to the use of vitamin D and 25(OH)D testing to lower the risk of disease. The panel prioritized randomized placebo-controlled trials in general populations (without an established indication for vitamin D treatment or 25[OH]D testing), evaluating the effects of empiric vitamin D administration throughout the lifespan, as well as in select conditions (pregnancy and prediabetes). The panel defined "empiric supplementation" as vitamin D intake that (a) exceeds the Dietary Reference Intakes (DRI) and (b) is implemented without testing for 25(OH)D. Systematic reviews queried electronic databases for publications related to these 14 clinical questions. The Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) methodology was used to assess the certainty of evidence and guide recommendations. The approach incorporated perspectives from a patient representative and considered patient values, costs and resources required, acceptability and feasibility, and impact on health equity of the proposed recommendations. The process to develop this clinical guideline did not use a risk assessment framework and was not designed to replace current DRI for vitamin D. Results The panel suggests empiric vitamin D supplementation for children and adolescents aged 1 to 18 years to prevent nutritional rickets and because of its potential to lower the risk of respiratory tract infections; for those aged 75 years and older because of its potential to lower the risk of mortality; for those who are pregnant because of its potential to lower the risk of preeclampsia, intra-uterine mortality, preterm birth, small-for-gestational-age birth, and neonatal mortality; and for those with high-risk prediabetes because of its potential to reduce progression to diabetes. Because the vitamin D doses in the included clinical trials varied considerably and many trial participants were allowed to continue their own vitamin D–containing supplements, the optimal doses for empiric vitamin D supplementation remain unclear for the populations considered. For nonpregnant people older than 50 years for whom vitamin D is indicated, the panel suggests supplementation via daily administration of vitamin D, rather than intermittent use of high doses. The panel suggests against empiric vitamin D supplementation above the current DRI to lower the risk of disease in healthy adults younger than 75 years. No clinical trial evidence was found to support routine screening for 25(OH)D in the general population, nor in those with obesity or dark complexion, and there was no clear evidence defining the optimal target level of 25(OH)D required for disease prevention in the populations considered; thus, the panel suggests against routine 25(OH)D testing in all populations considered. The panel judged that, in most situations, empiric vitamin D supplementation is inexpensive, feasible, acceptable to both healthy individuals and health care professionals, and has no negative effect on health equity. Conclusion The panel suggests empiric vitamin D for those aged 1 to 18 years and adults over 75 years of age, those who are pregnant, and those with high-risk prediabetes. Due to the scarcity of natural food sources rich in vitamin D, empiric supplementation can be achieved through a combination of fortified foods and supplements that contain vitamin D. Based on the absence of supportive clinical trial evidence, the panel suggests against routine 25(OH)D testing in the absence of established indications. These recommendations are not meant to replace the current DRIs for vitamin D, nor do they apply to people with established indications for vitamin D treatment or 25(OH)D testing. Further research is needed to determine optimal 25(OH)D levels for specific health benefits. [ABSTRACT FROM AUTHOR]

Published
2024
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3. American Association of Clinical Endocrinologists/American College of Endocrinology Clinical Practice Guidelines for the Diagnosis and Treatment of Postmenopausal Osteoporosis— 2020 Update Executive Summary

Author

Camacho, Pauline M., Petak, Steven M., Binkley, Neil, Diab, Dima L., Eldeiry, Leslie S., Farooki, Azeez, Harris, Steven T., Hurley, Daniel L., Kelly, Jennifer, Lewiecki, E. Michael, Pessah-Pollack, Rachel, McClung, Michael, Wimalawansa, Sunil J., and Watts, Nelson B.

Published
2020
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5. List of contributors

Author

Abrahamsen, Bo, primary, Adler, Robert A., additional, Ajjour, Sara, additional, Alemi, Mohammad Mehdi, additional, Anderson, Dennis E., additional, Arnett, Timothy R., additional, Assaad, Mariam A., additional, Ballane, Ghada T., additional, Baron, Roland, additional, Bassett, J.H. Duncan, additional, Bauer, Douglas C., additional, Bauman, William A., additional, Beavers, Kristen M., additional, Berry, Sarah D., additional, Bilezikian, John P., additional, Biver, Emmanuel, additional, Bliuc, Dana, additional, Bonewald, Lynda F., additional, Boskey, Adele L., additional, Bouxsein, Mary L., additional, Bravenboer, Nathalie, additional, Brown, Todd T., additional, Bukata, Susan V., additional, Burkhart, Katelyn, additional, Canalis, Ernesto, additional, Cardozo, Christopher, additional, Castillo, Alesha B., additional, Cauley, Jane A., additional, Center, Jacqueline R., additional, Chen, Julia C., additional, Civitelli, Roberto, additional, Cohen, Adi, additional, Cosman, Felicia, additional, Crandall, Carolyn J., additional, Crawford, Brooke M., additional, Cusano, Natalie E., additional, de Paula, Francisco J.A., additional, Delbaere, Kim, additional, Dempster, David W., additional, Diab, Dima L., additional, Dick-de-Paula, Ingrid, additional, DiMeglio, Linda A., additional, Drake, Matthew T., additional, Dubrovsky, Alanna M.K., additional, D’Onofrio, Luca, additional, Eastell, Richard, additional, Elder, Grahame J., additional, El-Hajj Fuleihan, Ghada A., additional, Ensrud, Kristine E., additional, Ferrari, Serge, additional, Freudenthal, Bernard, additional, Genant, Harry K., additional, Gerstenfeld, Louis C., additional, Giangregorio, Lora, additional, Gielen, Evelien, additional, Gold, Deborah T., additional, Goldring, Steven R., additional, Gordon, Catherine M., additional, Gori, Francesca, additional, Greendale, Gail A., additional, Griffith, James F., additional, Hadji, Peyman, additional, Hernandez, Christopher J., additional, Hoggatt, Jonathan, additional, Houston, Denise K., additional, Hussein, Amira I., additional, Jacobs, Christopher R., additional, Jiang, Xuezhi, additional, Johnston, James D., additional, Kagan, Risa, additional, Karim, Lamya, additional, Karvonen-Gutierrez, Carrie, additional, Katzman, Wendy B., additional, Kawai, Masanobu, additional, Khosla, Sundeep, additional, Kiel, Douglas P., additional, Kontulainen, Saija A., additional, Kostenuik, Paul, additional, Krez, Alexandra, additional, Kronenberg, Henry, additional, Kumar, Rajiv, additional, Lane, Nancy E., additional, Langsetmo, Lisa, additional, Laurent, Michaël R., additional, Lawenius, L., additional, Leikin, Sergey, additional, Leslie, William D., additional, Lewiecki, E. Michael, additional, Liu, Minghao, additional, Liu, Yi, additional, Lord, Stephen R., additional, Lorenzo, Joseph, additional, Ma, Nina S., additional, Maalouf, Naim M., additional, Marcus, Robert, additional, McClung, Michael R., additional, Mendes, Marcela Moraes, additional, Miller, Paul D., additional, Misra, Madhusmita, additional, Mohseni, Mahshid, additional, Morgan, Elise F., additional, Morin, Suzanne N., additional, Mukaddam, Mona Al, additional, Mulder, Chris J.J., additional, Nair, Nandini, additional, Napoli, Nicola, additional, Nasomyont, Nat, additional, Nelson, Dorothy A., additional, Nieves, Jeri W., additional, Nissenson, Robert, additional, Ohlsson, Claes, additional, Oleson, Christina V., additional, Ortinau, Laura, additional, Orwoll, Eric, additional, Ott, Susan M., additional, Pacifici, Roberto, additional, Palermo, Andrea, additional, Parfitt, A.M., additional, Park, Dongsu, additional, Provot, Sylvain, additional, Randhawa, Sonia Bhandari, additional, Randolph, John F., additional, Rivadeneira, Fernando, additional, Robey, Pamela Gehron, additional, Robinson, Lauren, additional, Rogers-Soeder, Tara, additional, Roodman, G. David, additional, Rosen, Clifford J., additional, Saag, Kenneth G., additional, Sahni, Shivani, additional, Sakhaee, Khashayar, additional, Scadden, David T., additional, Schafer, Anne L., additional, Schipani, Ernestina, additional, Serra, Monica C., additional, Shapiro, Jay R., additional, Sherrington, Catherine, additional, Shikany, James M., additional, Silverberg, Shonni J., additional, Singer, Andrea J., additional, Sjögren, K., additional, Snyder, Peter J., additional, Stein, Emily M., additional, Swanson, Christine M., additional, Szulc, Pawel, additional, Taxel, Pamela, additional, Tebben, Peter J., additional, Twardowski, Sarah E., additional, Uitterlinden, André G., additional, Vaidya, Rachana, additional, Vallera, Cristianna, additional, van Bodegraven, Adriaan A., additional, van der Eerden, Bram C.J., additional, van der Meulen, Marjolein C.H., additional, van Wijnen, André J., additional, Vanderschueren, Dirk, additional, Wactawski-Wende, Jean, additional, Watts, Laura, additional, Watts, Nelson B., additional, Weaver, Ashley A., additional, Weinstein, Robert S., additional, Williams, Graham R., additional, Wu, Joy, additional, Wu, Karin C., additional, Yin, Michael T., additional, Yu, Elaine W., additional, and Zhou, Hua, additional

Published
2021
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15. Contributors

Author

Adler, Robert A., primary, Anderson, Dennis E., additional, Arabi, Asma, additional, Arnett, Timothy R., additional, Bachrach, Laura K., additional, Ballane, Ghada, additional, Baran, Daniel, additional, Barnes, George L., additional, Baron, Roland, additional, Bauer, Douglas C., additional, Bauman, William A., additional, Berndt, Theresa J., additional, Berry, Sarah D., additional, Bilezikian, John P., additional, Bolam, Kate A., additional, Bonewald, Lynda F., additional, Bonnick, Sydney Lou, additional, Boonen†, Steven, additional, Boskey, Adele L., additional, Bouillon, Roger, additional, Bouxsein, Mary L., additional, Brown, Todd T., additional, Broy, Susan B., additional, Bruno, Alexander G., additional, Bukata, Susan V., additional, Burr, David B., additional, Canalis, Ernesto, additional, Cardozo, Christopher P., additional, Castillo, Alesha B., additional, Cauley, Jane A., additional, Center, Jacqueline R., additional, Chen, Julia C., additional, Civitelli, Roberto, additional, Cohen, Adi, additional, Coleman, Robert, additional, Compston, Juliet, additional, Cosman, Felicia, additional, Costa, Aline, additional, Cusano, Natalie E., additional, Daly, Robin M., additional, Danielson, Michelle E., additional, Dansey, Roger, additional, de Paula, Francisco J.A., additional, Delbaere, Kim, additional, Dempster, David W., additional, Diab, Dima L., additional, Dick-de-Paula, Ingrid, additional, DiMeglio, Linda A., additional, Einhorn, Thomas A., additional, Elder, Grahame J., additional, Ensrud, Kristine E., additional, Ettinger, Bruce, additional, Feldman, David, additional, Ferraro, Francesca, additional, Fitzpatrick, Lorraine A., additional, El-Hajj Fuleihan, Ghada, additional, Galvão, Daniel A., additional, Gass, Margery L.S., additional, Genant, Harry K., additional, Gold, Deborah T., additional, Goldring, Steven R., additional, Gori, Francesca, additional, Greendale, Gail A., additional, Griffith, James F., additional, Heaney, Robert P., additional, Heath, Hunter, additional, Hernandez, Christopher J., additional, Hoggatt, Jonathan, additional, Hoy, Christa L., additional, Hussein, Amira I., additional, Iwaniec, Urszula T., additional, Jacobs, Christopher R., additional, Jeffcoat, Marjorie K., additional, Johansson, Helena, additional, Judex, Stefan, additional, Kanis, John A., additional, Karim, Lamya, additional, Kawai, Masanobu, additional, Kemmis, Karen L., additional, Khan, Sobia, additional, Khosla, Sundeep, additional, Kiel, Douglas P., additional, Kostenuik, Paul, additional, Krishnan, Aruna V., additional, Kronenberg, Henry, additional, Kumar, Rajiv, additional, Leonard, Mary B., additional, Lewiecki, E. Michael, additional, Lian, Jane B., additional, Lindsay, Robert, additional, Lipton, Allan, additional, Lord, Stephen R., additional, Lorenzo, Joseph, additional, Luckey, Marjorie, additional, Macdonald, Heather M., additional, Marcus, Robert, additional, Martin, T. John, additional, McCloskey, Eugene V., additional, McClung, Michael R., additional, McDonnell, Donald P., additional, McKay, Heather A., additional, Miller, Paul, additional, Morgan, Elise F., additional, Mughal, M. Zulf, additional, Al Mukaddam, Mona, additional, Nelson, Erik R., additional, Nelson, Dorothy A., additional, Nieves, Jeri W., additional, Nissenson, Robert A., additional, Nordin, B.E. Christopher, additional, Odén, Anders, additional, Orwoll, Eric S., additional, Ott, Susan M., additional, Pacifici, Roberto, additional, Pack, Alison M., additional, Parfitt, A. Michael, additional, Park, Dongsu, additional, Premaor, Melissa, additional, Provot, Sylvain, additional, Qin, Yi-Xian, additional, Randolph, John F., additional, Reid, Ian R., additional, Rivadeneira, Fernando, additional, Rizzoli, René, additional, Robey, Pamela Gehron, additional, Roodman, G. David, additional, Rosen, Clifford J., additional, Rubin, Clinton T., additional, Rubin, Janet, additional, Saag, Kenneth G., additional, Saylor, Philip J., additional, Scadden, David T., additional, Schipani, Ernestina, additional, Shane, Elizabeth, additional, Shapiro, Jay R., additional, Sherrington, Catherine, additional, Silbermann, Rebecca, additional, Silva, Barbara C., additional, Silverberg, Shonni J., additional, Smith, Matthew R., additional, Snyder, Peter J., additional, Sowers, MaryFran R., additional, Stein, Gary S., additional, Stein, Emily, additional, Stern, Paula H., additional, Stuenkel, Cynthia A., additional, Suominen, Harri, additional, Swami, Srilatha, additional, Szulc, Pawel, additional, Taaffe, Dennis R., additional, Taylor, Brent C., additional, Tebben, Peter J., additional, Turner, Russell T., additional, Uitterlinden, André G., additional, van de Peppel, Jeroen, additional, Van der Eerden, Bram C.J., additional, van der Meulen, Marjolein C.H., additional, van Leeuwen, Johannes P.T.M., additional, Vanderschueren, Dirk, additional, Wagman, Rachel B., additional, Ward, Leanne, additional, Wardell, Suzanne E., additional, Watts, Nelson B., additional, Weinstein, Robert S., additional, Wiren, Kristine M., additional, Wu, Joy Y., additional, Yin, Michael T., additional, Zhou, Hua, additional, and Zillikens, M. Carola, additional

Published
2013
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29. Triglyceride Levels and Not Adipokine Concentrations Are Closely Related to Severity of Nonalcoholic Fatty Liver Disease in an Obesity Surgery Cohort

Author

Kashyap, Sangeeta R., primary, Diab, Dima L., additional, Baker, Allison R., additional, Yerian, Lisa, additional, Bajaj, Harpreet, additional, Gray-McGuire, Courtney, additional, Schauer, Philip R., additional, Gupta, Manjula, additional, Feldstein, Ariel E., additional, Hazen, Stanley L., additional, and Stein, Catherine M., additional

Published
2009
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30. Secondary Osteoporosis: Differential Diagnosis and Workup.

Author

DIAB, DIMA L. and WATTS, NELSON B.

Subjects
*OSTEOPENIA, *OSTEOPOROSIS diagnosis, *DISEASE risk factors, *BLOOD testing, *DIFFERENTIAL diagnosis, *MEDICAL screening, *OSTEOPOROSIS, *PHYSICAL diagnosis, *X-ray densitometry in medicine, *DIAGNOSIS
Abstract

Abstract: There are numerous causes of secondary osteoporosis including endocrine disorders, nutritional deficiencies, and other miscellaneous conditions and medications. It is essential to identify and address these factors to appropriately manage patients with osteoporosis. Failure to do so may result in further bone loss despite pharmacologic intervention for osteoporosis. The following diagnostic studies should be considered initially: complete blood count, complete metabolic panel, 25-hydroxyvitamin D level, testosterone level in men, and 24-hour urinary calcium, sodium, and creatinine. Further testing may be performed in selected patients depending on the clinical picture and results of the initial workup. [ABSTRACT FROM AUTHOR]

Published
2013
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31. Denosumabin osteoporosis

Author

Diab, Dima L and Watts, Nelson B

Abstract

Introduction:Denosumabis a fully human monoclonal antibody against the receptor activator of nuclear factor kappa-B ligand. It is an antiresorptive agent that reduces osteoclastogenesis.Areas covered:This drug evaluation reviews denosumab for use in osteoporosis. Denosumab has been shown to improve bone mineral density (BMD) and to reduce the incidence of new vertebral, hip and nonvertebral fractures in postmenopausal women. It prevents bone loss and reduces vertebral fracture risk in men with nonmetastatic prostate cancer who are receiving androgen deprivation therapy. It has also been shown to improve BMD in men with osteoporosis unrelated to androgen deprivation therapy. Safety concerns include infections, cancer, skin reactions, cardiovascular disease, hypocalcemia, osteonecrosis of the jaw and atypical femur fractures.Expert opinion:Although bisphosphonates are typically preferred as initial therapy for osteoporosis, denosumab could be used as initial therapy in select patients at high risk for fracture, including older patients who have difficulty with the dosing requirements of oral bisphosphonates, patients who are intolerant of or unresponsive to other therapies, and in those with impaired renal function. Additional data is needed to address issues regarding treatment duration and discontinuation, as well as to provide more information regarding denosumab's efficacy and safety.

Published
2014
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32. Denosumab in osteoporosis.

Author

Diab DL and Watts NB

Subjects
Denosumab, Fractures, Bone prevention & control, Humans, Antibodies, Monoclonal therapeutic use, Antibodies, Monoclonal, Humanized therapeutic use, Osteoporosis drug therapy
Abstract

Introduction: Denosumab is a fully human monoclonal antibody against the receptor activator of nuclear factor kappa-B ligand. It is an antiresorptive agent that reduces osteoclastogenesis., Areas Covered: This drug evaluation reviews denosumab for use in osteoporosis. Denosumab has been shown to improve bone mineral density (BMD) and to reduce the incidence of new vertebral, hip and nonvertebral fractures in postmenopausal women. It prevents bone loss and reduces vertebral fracture risk in men with nonmetastatic prostate cancer who are receiving androgen deprivation therapy. It has also been shown to improve BMD in men with osteoporosis unrelated to androgen deprivation therapy. Safety concerns include infections, cancer, skin reactions, cardiovascular disease, hypocalcemia, osteonecrosis of the jaw and atypical femur fractures., Expert Opinion: Although bisphosphonates are typically preferred as initial therapy for osteoporosis, denosumab could be used as initial therapy in select patients at high risk for fracture, including older patients who have difficulty with the dosing requirements of oral bisphosphonates, patients who are intolerant of or unresponsive to other therapies, and in those with impaired renal function. Additional data is needed to address issues regarding treatment duration and discontinuation, as well as to provide more information regarding denosumab's efficacy and safety.

Published
2014
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