Romosozumab efficacy in postmenopausal women with no prior fracture who fulfill criteria for very high fracture risk

Journal article

McClung, Michael R., Betah, Donald, Deignan, Cynthia, Shi, Yifei, Timoshanko, Jen and Cosman, Felicia. (2023). Romosozumab efficacy in postmenopausal women with no prior fracture who fulfill criteria for very high fracture risk. Endocrine Practice. 29(9), pp. 716-722. https://doi.org/10.1016/j.eprac.2023.06.011
AuthorsMcClung, Michael R., Betah, Donald, Deignan, Cynthia, Shi, Yifei, Timoshanko, Jen and Cosman, Felicia
Abstract

Objective
We evaluated the efficacy of romosozumab in women from FRAME who had no prior fracture but met other criteria for very high fracture risk (VHFR).

Methods
In FRAME, postmenopausal women received romosozumab or placebo for 12 months (year 1) followed by denosumab for 12 months (year 2). In this post hoc analysis, we applied the following criteria from the American Association of Clinical Endocrinology to define VHFR: lumbar spine or total hip T-score <−3.0 and/or Fracture Risk Assessment Tool probability of major osteoporotic fracture >30% or hip fracture >4.5% to women with no fracture history at baseline (no fracture-VHFR [NF-VHFR]). Incidence of new vertebral, clinical, and nonvertebral fractures and mean bone mineral density (BMD) percentage change from baseline were assessed at years 1 and 2.

Results
Of the 7180 women in FRAME, 2825 were included in the NF-VHFR subgroup analysis. At year 1, romosozumab versus placebo reduced the incidence of new vertebral fracture (relative risk reduction [RRR]: 76%), clinical fracture (RRR: 60%), and nonvertebral fracture (RRR: 54%) (all P <.05). This fracture reduction was maintained through year 2 in women receiving the romosozumab-to-denosumab sequence versus the placebo-to-denosumab sequence for new vertebral, clinical, and nonvertebral fractures (RRR: 77%, 54%, and 46%, respectively; all P <.05). The mean BMD changes in both treatment groups were similar to those in the overall FRAME population at years 1 and 2.

Conclusion
Romosozumab significantly reduced vertebral, clinical, and nonvertebral fracture risk and increased the BMD more than placebo in women at VHFR.

KeywordsAmerican Association of Clinical; Endocrinology (AACE); bone mineral density (BMD); osteoporosis; very high fracture risk (VHFR); treatment sequence
Year2023
JournalEndocrine Practice
Journal citation29 (9), pp. 716-722
PublisherAmerican Association of Clinical Endocrinologists
ISSN1530-891X
Digital Object Identifier (DOI)https://doi.org/10.1016/j.eprac.2023.06.011
PubMed ID37406858
Scopus EID2-s2.0-85169308309
Open accessPublished as ‘gold’ (paid) open access
Page range716-722
FunderAmgen, Inc.
UCB Pharma
Astellas Pharma
Publisher's version
License
File Access Level
Open
Output statusPublished
Publication dates
Online11 Sep 2023
Publication process dates
Accepted28 Jun 2023
Deposited04 Apr 2025
Additional information

© 2023 AACE. Published by Elsevier Inc. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

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McClung, Michael, Wagman, Rachel B., Miller, Paul, Wang, Andrea and Lewiecki, E M.. (2017). Observations following discontinuation of long-term denosumab therapy. Osteoporosis International. 28(5), pp. 1723 - 1732. https://doi.org/10.1007/s00198-017-3919-1
Bone mineral density and parathyroid hormone as independent risk factors for mortality in community-dwelling older adults: A population-based prospective cohort study in Brazil. The Sao Paulo Ageing & Health (SPAH) study
Domiciano, Diogo S., Machado, Luana G., Lopes, Jaqueline B., Figueiredo, Camille P., Caparbo, Valeria F., Oliveira, Ricardo M., Scazufca, Marcia, McClung, Michael R. and Pereira, Rosa M.R.. (2016). Bone mineral density and parathyroid hormone as independent risk factors for mortality in community-dwelling older adults: A population-based prospective cohort study in Brazil. The Sao Paulo Ageing & Health (SPAH) study. Journal of Bone and Mineral Research. 31(6), pp. 1146 - 1157. https://doi.org/10.1002/jbmr.2795
A phase 2 study of MK-5442, a calcium-sensing receptor antagonist, in postmenopausal women with osteoporosis after long-term use of oral bisphosphonates
Cosman, F., Gilchrist, N., McClung, Michael R., Foldes, J., de Villiers, T., Santora, A., Leung, A. T., Samanta, S., Heyden, N., McGinnis, J.P., Rosenberg, E. and Denker, A.E.. (2016). A phase 2 study of MK-5442, a calcium-sensing receptor antagonist, in postmenopausal women with osteoporosis after long-term use of oral bisphosphonates. Osteoporosis International. 27(1), pp. 377 - 386. https://doi.org/10.1007/s00198-015-3392-7
Vertebral fractures: Clinical importance and management
Kendler, D. L., Bauer, Doug C., Davison, K. S., Dian, L., Hanley, David A., Harris, S. T., McClung, Michael R., Miller, P. D., Schousboe, J. T., Yuen, C. K. and Lewiecki, E. Michael. (2016). Vertebral fractures: Clinical importance and management. American Journal of Medicine. 129(2), pp. 1 - 10. https://doi.org/10.1016/j.amjmed.2015.09.020
Proceedings of the 2015 Santa Fe Bone Symposium: Clinical applications of scientific advances in osteoporosis and metabolic bone disease
Lewiecki, E. Michael, Baron, Roland, Bilezikian, John P., Gagel, Robert E., Leonard, Mary B., Leslie, William D., McClung, Michael R. and Miller, Paul D.. (2016). Proceedings of the 2015 Santa Fe Bone Symposium: Clinical applications of scientific advances in osteoporosis and metabolic bone disease. United States of America: Elsevier Inc.. pp. 102 - 116 https://doi.org/10.1016/j.jocd.2015.11.003
Denosumab reduces cortical porosity of the proximal femoral shaft in postmenopausal women with osteoporosis
Zebaze, Roger M., Libanati, Cesar, McClung, Michael R., Zanchetta, Jose Ruben, Kendler, David L., Høiseth, Arne, Wang, Andrea, Ghasem-Zadeh, Ali and Seeman, Ego. (2016). Denosumab reduces cortical porosity of the proximal femoral shaft in postmenopausal women with osteoporosis. Journal of Bone and Mineral Research. 31(10), pp. 1827 - 1834. https://doi.org/10.1002/jbmr.2855
Emerging therapies for osteoporosis
McClung, Michael R.. (2015). Emerging therapies for osteoporosis. Endocrinology and Metabolism. 30(4), pp. 429 - 435. https://doi.org/10.3803/EnM.2015.30.4.429
Odanacatib for the treatment of postmenopausal osteoporosis: Development history and design and participant characteristics of LoFT, the Long-term odanacatib Fracture Trial
Bone, Henry G., Dempster, David W., Eisman, John A., Greenspan, S. L., McClung, Michael R., Nakamura, T., Papapoulos, S., Shih, W. J., Rybak-Feiglin, A., Santora, A. C., Verbruggen, Nadia, Leung, A. T. and Lombardi, Antonio. (2015). Odanacatib for the treatment of postmenopausal osteoporosis: Development history and design and participant characteristics of LoFT, the Long-term odanacatib Fracture Trial. Osteoporosis International. 26(2), pp. 699 - 712. https://doi.org/10.1007/s00198-014-2944-6
A 24-month study evaluating the efficacy and safety of denosumab for the treatment of men with low bone mineral density: Results from the ADAMO trial
Langdahl, Bente Lomholt, Teglbjaerg, Christence S., Ho, Pei-Ran, Chapurlat, Roland D., Czerwinski, Edward, Kendler, David L., Reginster, Jean Yves, Kivitz, Alan, Lewiecki, E. Michael, Miller, Paul D., Bolognese, Michael A., McClung, Michael R., Bone, Henry G., Ljunggren, Östen, Abrahamsen, Bo, Gruntmanis, Ugis, Yang, Yu-Ching, Wagman, Rachel B., Mirza, Faisal, ... Orwoll, Eric. (2015). A 24-month study evaluating the efficacy and safety of denosumab for the treatment of men with low bone mineral density: Results from the ADAMO trial. The Journal of Clinical Endocrinology and Metabolism. 100(4), pp. 1335 - 1342. https://doi.org/10.1210/jc.2014-4079
Serum 25-hydroxyvitamin D levels: Variability, knowledge gaps, and the concept of a desirable range
El-Hajj Fuleihan, Ghada, Bouillon, Roger, Clarke, Bart, Chakhtoura, Marlene, Cooper, Cyrus, McClung, Michael R. and Singh, Ravinder J.. (2015). Serum 25-hydroxyvitamin D levels: Variability, knowledge gaps, and the concept of a desirable range. Journal of Bone and Mineral Research. 30(7), pp. 1119 - 1133. https://doi.org/10.1002/jbmr.2536
Comparison of proximal femur and vertebral body strength improvements in the FREEDOM trial using an alternative finite element methodology
Zysset, Philippe, Pahr, Dieter, Engelke, Klaus, Genant, Harry K., McClung, Michael R., Kendler, David L., Recknor, Christopher, Kinzl, Michael, Schwiedrzik, Jakob, Museyko, Oleg, Wang, Andrea and Libanati, Cesar. (2015). Comparison of proximal femur and vertebral body strength improvements in the FREEDOM trial using an alternative finite element methodology. Bone. 81(December), pp. 122 - 130. https://doi.org/10.1016/j.bone.2015.06.025
Denosumab rapidly increases cortical bone in key locations of the femur: A 3D bone mapping study in women with osteoporosis
Poole, Kenneth E.S., Treece, Graham M., Gee, Andrew H., Brown, Jacques P., McClung, Michael R., Wang, Andrea and Libanati, Cesar. (2015). Denosumab rapidly increases cortical bone in key locations of the femur: A 3D bone mapping study in women with osteoporosis. Journal of Bone and Mineral Research. 30(1), pp. 46 - 54. https://doi.org/10.1002/jbmr.2325
Creation of an age-adjusted, dual-energy x-ray absorptiometry-derived trabecular bone score curve for the lumbar spine in non-hispanic US white women
Simonelli, Christine, Leib, Edward, Mossman, Ned, Winzenrieth, Renaud, Hans, Didier and McClung, Michael R.. (2014). Creation of an age-adjusted, dual-energy x-ray absorptiometry-derived trabecular bone score curve for the lumbar spine in non-hispanic US white women. Journal of Clinical Densitometry. 17(2), pp. 314 - 319. https://doi.org/10.1016/j.jocd.2013.09.002
Femoral and vertebral strength improvements in postmenopausal women with osteoporosis treated with denosumab
Keaveny, Tony M., McClung, Michael R., Genant, Harry K., Zanchetta, Jose Ruben, Kendler, David, Brown, Jacques P., Goemaere, Stefan, Recknor, Christopher, Brandi, Maria Luisa, Eastell, Richard, Kopperdahl, David L., Engelke, Klaus, Fuerst, Thomas, Radcliffe, Hoi-Shen and Libanati, Cesar. (2014). Femoral and vertebral strength improvements in postmenopausal women with osteoporosis treated with denosumab. Journal of Bone and Mineral Research. 29(1), pp. 158 - 165. https://doi.org/10.1002/jbmr.2024
Bone safety with risedronate: histomorphometric studies at different dose levels and exposure
Recker, Robert R., SteMarie, L.-G., Chavassieux, P., McClung, Michael R. and Lundy, M. W.. (2014). Bone safety with risedronate: histomorphometric studies at different dose levels and exposure. Osteoporosis International. 26(1), pp. 327 - 337. https://doi.org/10.1007/s00198-014-2850-y
Romosozumab in postmenopausal women with low bone mineral density
McClung, Michael R., Grauer, Andreas, Boonen, Steven and Bolognese, Michael A.. (2014). Romosozumab in postmenopausal women with low bone mineral density. New England Journal of Medicine. 370(5), pp. 412 - 420. https://doi.org/10.1056/NEJMoa1305224
Tibolone
McClung, M. R.. (2013). Tibolone. In In Genazzani, Andrea R. (Ed.). Postmenopausal osteoporosis : Hormones and other therapies pp. 233-238 Taylor & Francis. https://doi.org/10.1201/b14631-28
Bisphosphonate therapy for osteoporosis: Benefits, risks, and drug holiday
McClung, Michael R., Harris, Steven T., Miller, Paul D., Bauer, Doug C., Davison, K. Shawn, Dian, Larry, Hanley, David A., Kendler, David L., Yuen, Chui Kin and Lewiecki, E. Michael. (2013). Bisphosphonate therapy for osteoporosis: Benefits, risks, and drug holiday. American Journal of Medicine. 126(1), pp. 13 - 20. https://doi.org/10.1016/j.amjmed.2012.06.023
A novel monthly dosing regimen of risedronate for the treatment of postmenopausal Osteoporosis: 2-year data
McClung, Michael R., Benhamou, Claude-Laurent, Man, Zulema, Tlustochowicz, Witold, Zanchetta, Jose Ruben, Eusebio, Rachelle, Balske, Ana M., Matzkin, Ellen, Olszynski, Wojciech P., Recker, Robert R. and Delmas, Pierre D.. (2013). A novel monthly dosing regimen of risedronate for the treatment of postmenopausal Osteoporosis: 2-year data. Calcified Tissue International. 92(1), pp. 59 - 67. https://doi.org/10.1007/s00223-012-9668-4
Impact of denosumab on the peripheral skeleton of postmenopausal women with osteoporosis: Bone density, mass, and strength of the radius, and wrist fracture
Simon, James A., Recknor, Christopher, Moffett, Alfred H., Adachi, Jonathan D., Franek, Edward, Lewiecki, E. Michael, McClung, Michael R., Mautalen, Carlos A., Ragi-Eis, Sergio, Nicholson, Geoffrey Charles, Muschitz, Christian, Nuti, Ranuccio, Torring, Ove, Wang, Andrea and Libanati, Cesar. (2013). Impact of denosumab on the peripheral skeleton of postmenopausal women with osteoporosis: Bone density, mass, and strength of the radius, and wrist fracture. Menopause. 20(2), pp. 130 - 137. https://doi.org/10.1097/gme.0b013e318267f909
Efficacy and safety of risedronate 150-mg once a month in the treatment of postmenopausal osteoporosis: 2-year data
McClung, Michael R., Zanchetta, Jose Ruben, Racewicz, A., Roux, Christian, Benhamou, Claude-Laurent, Man, Zulema, Eusebio, Rachelle, Beary, J. F., Burgio, D.E., Matzkin, Ellen, Boonen, Steven and Delmas, P. D.. (2013). Efficacy and safety of risedronate 150-mg once a month in the treatment of postmenopausal osteoporosis: 2-year data. Osteoporosis International. 24(1), pp. 293 - 299. https://doi.org/10.1007/s00198-012-2056-0
Treatment of postmenopausal osteoporosis with delayed-release risedronate 35 mg weekly for 2 years
McClung, Michael R., Balske, Ana M., Burgio, D. E., Wenderoth, D. and Recker, Robert R.. (2013). Treatment of postmenopausal osteoporosis with delayed-release risedronate 35 mg weekly for 2 years. Osteoporosis International. 24(1), pp. 301 - 310. https://doi.org/10.1007/s00198-012-2175-7
Effects of pioglitazone on bone in postmenopausal women with impaired fasting glucose or impaired glucose tolerance: A randomized, double-Blind, placebo-controlled study
Bone, Henry G., Lindsay, Robert, McClung, Michael R., Perez, Alfonso T., Raanan, Marsha G. and Spanheimer, Robert G.. (2013). Effects of pioglitazone on bone in postmenopausal women with impaired fasting glucose or impaired glucose tolerance: A randomized, double-Blind, placebo-controlled study. The Journal of Clinical Endocrinology and Metabolism. 98(12), pp. 4691 - 4701. https://doi.org/10.1210/jc.2012-4096
Controversies in osteoporosis management: Concerns about bisphosphonates and when are "drug holidays" required?
McClung, Michael R.. (2013). Controversies in osteoporosis management: Concerns about bisphosphonates and when are "drug holidays" required? Clinical Obstetrics and Gynecology. 56(4), pp. 743 - 748. https://doi.org/10.1097/GRF.0b013e3182a98295
Denosumab densitometric changes assessed by quantitative computed tomography at the spine and hip in postmenopausal women with osteoporosis
McClung, Michael R., Zanchetta, Jose Ruben, Høiseth, Arne, Kendler, David L., Yuen, Chui Kin, Brown, Jacques P., Stonkus, Sigtas, Goemaere, Stefan, Recknor, Christopher, Woodson, Grattan C., Bolognese, Michael A., Franek, Edward, Brandi, Maria Luisa, Wang, Andrea and Libanati, Cesar. (2013). Denosumab densitometric changes assessed by quantitative computed tomography at the spine and hip in postmenopausal women with osteoporosis. Journal of Clinical Densitometry. 16(2), pp. 250 - 256. https://doi.org/10.1016/j.jocd.2012.02.014
Effect of denosumab on bone mineral density and biochemical markers of bone turnover: 8-year results of a phase 2 clinical trial
McClung, Michael R., Lewiecki, E. Michael, Geller, M. L. and Bolognese, Michael A.. (2013). Effect of denosumab on bone mineral density and biochemical markers of bone turnover: 8-year results of a phase 2 clinical trial. Osteoporosis International. 24(1), pp. 227 - 235. https://doi.org/10.1007/s00198-012-2052-4
In Memoriam: Sergio Ragi-Eis, MD
McClung, Michael. (2012). In Memoriam: Sergio Ragi-Eis, MD. Archives of Osteoporosis. 7(43862), pp. 1 - 2. https://doi.org/10.1007/s11657-012-0081-4
Effect of denosumab treatment on the risk of fractures in subgroupsof women with postmenopausal osteoporosis
McClung, Michael R., Boonen, Steven, Torring, Ove, Roux, Christian, Rizzoli, Rene, Bone, Henry G., Benhamou, Claude-Laurent, Lems, Willem F., Minisola, Salvatore, Halse, Johan, Hoeck, Hans C., Eastell, Richard, Wang, Andrea, Siddhanti, Suresh and Cummings, Steven R.. (2012). Effect of denosumab treatment on the risk of fractures in subgroupsof women with postmenopausal osteoporosis. Journal of Bone and Mineral Research. 27(1), pp. 211 - 218. https://doi.org/10.1002/jbmr.536
In memoriam: Sergio Ragi-Eis, MD
McClung, Michael R.. (2012). In memoriam: Sergio Ragi-Eis, MD. Journal of Clinical Densitometry. 23(6), pp. 1651 - 1652. https://doi.org/10.1007/s00198-012-1980-3
In memoriam: Sergio Ragi-Eis, MD, CCD, CDT (April 8, 1962-February 22, 2012)
Bilezikian, John P., Zerbini, Cristiano, Lewiecki, E. Michael, Borges, Joao Lindolfo, Miller, Paul D., Hans, Didier, Camargos, Bruno Muzzi and McClung, Michael R.. (2012). In memoriam: Sergio Ragi-Eis, MD, CCD, CDT (April 8, 1962-February 22, 2012). Osteoporosis International. 15(3), pp. 257 - 259. https://doi.org/10.1016/j.jocd.2012.05.003
Revisiting the prevention of bone loss at menopause
McClung, Michael R.. (2012). Revisiting the prevention of bone loss at menopause. Menopause. 19(11), pp. 1173 - 1175. https://doi.org/10.1097/gme.0b013e318274fb1d
Femoral strength in osteoporotic women treated with teriparatide or alendronate
Keaveny, Tony M., McClung, Michael R., Wan, Xiaohai, Kopperdahl, David L., Mitlak, Bruce H. and Krohn, Kelly. (2012). Femoral strength in osteoporotic women treated with teriparatide or alendronate. Bone. 50(1), pp. 165 - 170. https://doi.org/10.1016/j.bone.2011.10.002
Odanacatib in the treatment of postmenopausal women with low bone mineral density: Three-year continued therapy and resolution of effect
Eisman, John A., Bone, Henry G., Hosking, David J., McClung, Michael R., Reid, Ian R., Rizzoli, Rene, Resch, Heinrich, Verbruggen, Nadia, Hustad, Carolyn M., DaSilva, Carolyn, Petrovic, Romana, Santora, Arthur C., Ince, B. Avery and Lombardi, Antonio. (2011). Odanacatib in the treatment of postmenopausal women with low bone mineral density: Three-year continued therapy and resolution of effect. Journal of Bone and Mineral Research. 26(2), pp. 242 - 251. https://doi.org/10.1002/jbmr.212
Effects of denosumab on fracture and bone mineral density by level of kidney function
Jamal, Sophie A., Ljunggren, Östen, Stehman-Breen, Catherine, Cummings, Steven R., McClung, Michael R., Goemaere, Stefan, Ebeling, Peter R., Franek, Edward, Yang, Yu-ching, Egbuna, Ogo I., Boonen, Steven and Miller, Paul D.. (2011). Effects of denosumab on fracture and bone mineral density by level of kidney function. Journal of Bone and Mineral Research. 26(8), pp. 1829 - 1835. https://doi.org/10.1002/jbmr.403
Effects of denosumab on bone turnover markers in postmenopausal osteoporosis
Eastell, Richard, Christiansen, Claus, Grauer, Andreas, Kutilek, Stepan, Libanati, Cesar, McClung, Michael R., Reid, Ian R., Resch, Heinrich, Siris, Ethel, Uebelhart, Daniel, Wang, Andrea, Weryha, Georges and Cummings, Steven R.. (2011). Effects of denosumab on bone turnover markers in postmenopausal osteoporosis. Journal of Bone and Mineral Research. 26(3), pp. 530 - 537. https://doi.org/10.1002/jbmr.251
Osteoporosis update from the 2010 Santa Fe Bone Symposium
Lewiecki, E. Michael, Bilezikian, John P., Khosla, Sundeep, Marcus, Robert, McClung, Michael R., Miller, Paul D., Watts, Nelson B. and Maricic, Michael. (2011). Osteoporosis update from the 2010 Santa Fe Bone Symposium. Journal of Clinical Densitometry. 14(1), pp. 1 - 21. https://doi.org/10.1016/j.jocd.2010.12.001
Treatment with denosumab reduces the incidence of new vertebral and hip fractures in postmenopausal women at high risk
Boonen, Steven, Adachi, Jonathan D., Man, Zulema, Cummings, Steven R., Lippuner, K., Torring, Ove, Gallagher, J.C., Farrerons, J., Wang, Andrea, Franchimont, N., San Martin, Javier, Grauer, Andreas and McClung, Michael R.. (2011). Treatment with denosumab reduces the incidence of new vertebral and hip fractures in postmenopausal women at high risk. The Journal of Clinical Endocrinology and Metabolism. 96(6), pp. 1727 - 1736. https://doi.org/10.1210/jc.2010-2784
Markers of bone turnover for the prediction of fracture risk and monitoring of osteoporosis treatment: A need for international reference standards
Vasikaran, Samuel, Eastell, Richard, Bruyere, O., Foldes, A. J., Garnero, P., Griesmacher, Andrea, McClung, Michael R., Morris, Howard A., Silverman, S., Trenti, Tommaso, Wahl, D. A., Cooper, Cyrus and Kanis, John A.. (2011). Markers of bone turnover for the prediction of fracture risk and monitoring of osteoporosis treatment: A need for international reference standards. Osteoporosis International. 22(2), pp. 391 - 420. https://doi.org/10.1007/s00198-010-1501-1
Arzoxifene for prevention of fractures and invasive breast cancer in postmenopausal women
Cummings, Steven R., McClung, Michael R., Reginster, Jean-Yves, Cox, David, Mitlak, Bruce, Stock, John, Amewou-Atisso, Messan, Powles, Trevor, Miller, Paul, Zanchetta, Jose Ruben and Christiansen, Claus. (2011). Arzoxifene for prevention of fractures and invasive breast cancer in postmenopausal women. Journal of Bone and Mineral Research. 26(2), pp. 397 - 404. https://doi.org/10.1002/jbmr.191