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1. Effect of Romosozumab Treatment in Postmenopausal Women With Osteoporosis and Knee Osteoarthritis: Results From a Substudy of a Phase 3 Clinical Trial

Author

Lane, Nancy E, Betah, Donald, Deignan, Cynthia, Oates, Mary, Wang, Zhenxun, Timoshanko, Jen, Khan, Aliya A, and Binkley, Neil

Subjects
Reproductive Medicine, Biomedical and Clinical Sciences, Clinical Sciences, Clinical Trials and Supportive Activities, Chronic Pain, Arthritis, Osteoporosis, Pain Research, Clinical Research, Aging, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Musculoskeletal, Clinical sciences
Abstract

ObjectiveRomosozumab is a bone-forming agent approved for osteoporosis treatment. Here we report results of the protocol-specified, noninferiority osteoarthritis substudy of the fracture study in postmenopausal women with osteoporosis (FRAME), which evaluated the effect of romosozumab versus placebo on knee osteoarthritis in patients with a clinical history of osteoarthritis.MethodsWomen in FRAME with a history of knee osteoarthritis were eligible for enrollment in the osteoarthritis substudy; key inclusion criteria were osteoarthritis-related signal knee pain, morning stiffness lasting less than 30 minutes, knee crepitus, and knee osteoarthritis confirmed by x-ray within 12 months. The protocol-specified outcomes were change from baseline through month 12 in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score, incidence of worsening knee osteoarthritis, and treatment-emergent adverse events (TEAEs) with romosozumab versus placebo. In a post hoc analysis, percentage change from baseline to month 12 in bone mineral density (BMD) was assessed.ResultsOf 7180 women in FRAME, 347 participated in the osteoarthritis substudy (placebo, 177; romosozumab, 170). At month 12, no significant difference in progression of knee osteoarthritis was observed with romosozumab versus placebo (least squares mean total WOMAC score: -2.2 vs. -1.3; P = 0.71). Incidence of worsening symptoms of knee osteoarthritis was comparable between romosozumab (17.1%) and placebo (20.5%) (odds ratio 0.9 [95% confidence interval: 0.5, 1.7]; P = 0.69). Incidence of TEAEs of osteoarthritis was numerically lower with romosozumab (13 [7.7%]) versus placebo (21 [12.0%]). BMD gains were higher with romosozumab.ConclusionRomosozumab treatment did not impact knee pain or function in postmenopausal women with osteoporosis and knee osteoarthritis and resulted in significant BMD gains in these women.

Published
2023

4. Efficacy of Apremilast in Patients with Moderate-to-Severe Genital Psoriasis: Body Surface Area Subgroup Results from the Phase 3 DISCREET Trial

Author

Merola, Joseph F., primary, Parish, Lawrence Charles, additional, Guenther, Lyn, additional, Lynde, Charles, additional, Lacour, Jean-Philippe, additional, Staubach, Petra, additional, Cheng, Sue, additional, Deignan, Cynthia, additional, Chen, Mindy, additional, Papp, Kim A., additional, and Nicewarner, Dawn, additional

Published
2023
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5. Effect of Romosozumab Treatment in Postmenopausal Women With Osteoporosis and Knee Osteoarthritis: Results From a Substudy of a Phase 3 Clinical Trial.

Author

Lane, Nancy E., Betah, Donald, Deignan, Cynthia, Oates, Mary, Wang, Zhenxun, Timoshanko, Jen, Khan, Aliya A., and Binkley, Neil

Subjects
THERAPEUTIC use of monoclonal antibodies, DISEASE complications, KNEE osteoarthritis, STATISTICS, CONFIDENCE intervals, OSTEOPOROSIS, TREATMENT effectiveness, COMPARATIVE studies, POSTMENOPAUSE, DESCRIPTIVE statistics, RESEARCH funding, DATA analysis, ODDS ratio, EVALUATION
Abstract

Objective: Romosozumab is a bone‐forming agent approved for osteoporosis treatment. Here we report results of the protocol‐specified, noninferiority osteoarthritis substudy of the fracture study in postmenopausal women with osteoporosis (FRAME), which evaluated the effect of romosozumab versus placebo on knee osteoarthritis in patients with a clinical history of osteoarthritis. Methods: Women in FRAME with a history of knee osteoarthritis were eligible for enrollment in the osteoarthritis substudy; key inclusion criteria were osteoarthritis‐related signal knee pain, morning stiffness lasting less than 30 minutes, knee crepitus, and knee osteoarthritis confirmed by x‐ray within 12 months. The protocol‐specified outcomes were change from baseline through month 12 in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score, incidence of worsening knee osteoarthritis, and treatment‐emergent adverse events (TEAEs) with romosozumab versus placebo. In a post hoc analysis, percentage change from baseline to month 12 in bone mineral density (BMD) was assessed. Results: Of 7180 women in FRAME, 347 participated in the osteoarthritis substudy (placebo, 177; romosozumab, 170). At month 12, no significant difference in progression of knee osteoarthritis was observed with romosozumab versus placebo (least squares mean total WOMAC score: –2.2 vs. –1.3; P = 0.71). Incidence of worsening symptoms of knee osteoarthritis was comparable between romosozumab (17.1%) and placebo (20.5%) (odds ratio 0.9 [95% confidence interval: 0.5, 1.7]; P = 0.69). Incidence of TEAEs of osteoarthritis was numerically lower with romosozumab (13 [7.7%]) versus placebo (21 [12.0%]). BMD gains were higher with romosozumab. Conclusion: Romosozumab treatment did not impact knee pain or function in postmenopausal women with osteoporosis and knee osteoarthritis and resulted in significant BMD gains in these women. [ABSTRACT FROM AUTHOR]

Published
2024
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6. Closing the gap in osteoporosis management: the critical role of primary care in bone health

Author

Singer, Andrea J., Sharma, Anita, Deignan, Cynthia, and Borgermans, Liesbeth

Subjects
General Medicine
Abstract

The World Health Organization issued a call to action for primary care to lead efforts in managing noncommunicable diseases, including osteoporosis. Although common, osteoporosis remains underdiagnosed and undertreated. Primary care practitioners (PCPs) are critical in identifying individuals at risk for osteoporosis and osteoporotic fractures; however, recent advances in assessment, diagnosis, and treatment of osteoporosis have not been incorporated into clinical practice in primary care due to numerous reasons including time constraints and insufficient knowledge. To close this gap in clinical practice, we believe PCPs need a practical strategy to facilitate osteoporosis assessment and management that is easy to implement. In this article, we consolidate information from various global guidelines and highlight areas of agreement to create a streamlined osteoporosis management strategy for a global audience of PCPs. We present a systematic approach to facilitate osteoporosis assessment and management that includes four steps: (1) identifying patients at risk through proactive screening strategies, (2) investigating and diagnosing patients, (3) intervening with personalized treatment plans, and (4) implementing patient-centered strategies for long-term management and monitoring of patients. Primary care has a central role in ensuring the incorporation of key elements of holistic care as outlined by the World Health Organization in managing noncommunicable diseases including osteoporosis; namely, a people-centered approach, incorporation of specialist services, and multidisciplinary care. This approach is designed to strengthen the health system’s response to the growing osteoporosis epidemic. Osteoporosis is a chronic condition associated with aging in which bones become “porous” and weak, and are more likely to break (i.e., fracture) even with minimal trauma such as tripping or falling from a standing height. A broken bone is a serious condition that not only affects daily activities, but can also lead to reduced quality of life, need for caregiver support, work loss, hospital and rehabilitation costs, nursing home costs, and increased mortality. Although osteoporosis is common, it is often undiagnosed or untreated, leaving many people at risk for experiencing broken bones. A broken bone increases the risk of more broken bones. Given the growing size of the aging global population, osteoporosis and the risk of broken bones represent an urgent problem and growing burden. We need ways to make it easier for primary care practitioners (PCPs), such as family physicians, internists, physician assistants, nurse practitioners, and nurses, to include osteoporosis care as part of routine clinical visits. In this article, we discuss the critical role of PCPs in early detection, diagnosis, and treatment of osteoporosis as they are often the first point of contact for at-risk patients. We present a simple, four-step approach to help PCPs and patients navigate the journey from osteoporosis diagnosis to a treatment plan. The four steps are to: (1) identify at-risk patients by screening for weak bones or osteoporosis, (2) perform necessary tests to diagnose patients, (3) develop a personalized treatment plan, and (4) determine long-term strategies for managing and monitoring bone health. Thoracic endovascular aortic repair of a large, multilobulated, calcified thoracic aneurysm. Read the transcript Watch the video on Vimeo

Published
2023
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7. Romosozumab Followed by Antiresorptive Treatment Increases the Probability of Achieving Bone Mineral Density Treatment Goals

Author

Cosman, Felicia, primary, Libanati, Cesar, additional, Deignan, Cynthia, additional, Yu, Zhigang, additional, Wang, Zhenxun, additional, Ferrari, Serge, additional, Beck Jensen, Jens‐Erik, additional, Peris, Pilar, additional, Bertoldo, Francesco, additional, Lespessailles, Eric, additional, Hesse, Eric, additional, and Cummings, Steven R, additional

Published
2021
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8. Romosozumab Followed by Antiresorptive Treatment Increases the Probability of Achieving Bone Mineral Density Treatment Goals

Author

Cosman, Felicia, Libanati, Cesar, Deignan, Cynthia, Yu, Zhigang, Wang, Zhenxun, Ferrari, Serge, Beck Jensen, Jens Erik, Peris, Pilar, Bertoldo, Francesco, Lespessailles, Eric, Hesse, Eric, Cummings, Steven R., Cosman, Felicia, Libanati, Cesar, Deignan, Cynthia, Yu, Zhigang, Wang, Zhenxun, Ferrari, Serge, Beck Jensen, Jens Erik, Peris, Pilar, Bertoldo, Francesco, Lespessailles, Eric, Hesse, Eric, and Cummings, Steven R.

Abstract

Increases in bone mineral density (BMD) with osteoporosis treatment are associated with reduced fracture risk. Increasing BMD is therefore a goal of osteoporosis therapy. Here, we compare the probability of achieving a T-score of > −2.5 over 3 years at the total hip (TH) or lumbar spine (LS) in women with osteoporosis, ≥55 years of age, after the following treatment sequences: 1 year romosozumab followed by 2 years denosumab (FRAME and FRAME extension trials), 1 year romosozumab followed by 2 years alendronate, or alendronate-only for 3 years (ARCH trial). Probabilities of attaining the BMD target within 1 year of treatment were also determined. At both skeletal sites, in women with a baseline Tscore ≥ −2.7, there was >50% probability of achieving the BMD target with any 3-year regimen. The probability of achieving the target BMD in those with a baseline TH Tscore equal to −3.0 was 61% with romosozumab/denosumab, 38% with romosozumab/alendronate, and 9% with alendronate. In those with a baseline LS Tscore equal to −3.0, the probability of achieving a T-score > −2.5 was 93% with romosozumab/denosumab, 81% with romosozumab/alendronate, and 55% with alendronate. With 1 year of treatment, in patients with a baseline TH T-score equal to −2.7, the probability of reaching the target Tscore with romosozumab was 71% to 78% and 38% with alendronate. For patients with an initial LS T-score equal to −3.0, the probability of achieving the target T-score over 1 year was 85% to 86% with romosozumab and 25% for alendronate. Our findings suggest baseline BMD and the probability of achieving BMD T-score goals are factors to consider when selecting initial treatment for patients with osteoporosis. As baseline T-score falls below −2.7 (TH) and −3.0 (LS), alendronate has <50% likelihood of achieving a BMD goal above osteoporosis range, whereas these probabilities remain relatively high for regimens beginning with romosozumab.

Published
2021

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