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1Department of Internal Medicine, Severance Hospital, Endocrine Research Institute, Yonsei University College of Medicine, Seoul, Korea
2Department of Orthopedic Surgery, Inje University Sanggye Paik Hospital, College of Medicine, Inje University, Seoul, Korea
3Division of Endocrinology and Metabolism, Department of Internal Medicine, Seoul St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea
4Amgen Korea Ltd., Seoul, Korea
5Division of Endocrinology and Metabolism, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
Copyright © 2022 Korean Endocrine Society
This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
CONFLICTS OF INTEREST
Sooa Kim, YuSun Lee, and Euna Jo are employees of Amgen Korea. This study was sponsored by Amgen Inc.
AUTHOR CONTRIBUTIONS
Conception or design: Y.R., D.G.C., J.H., S.K., J.M.K. Acquisition, analysis, or interpretation of data: Y.R., D.G.C., J.H., S.K., Y.L., E.J., J.M.K. Drafting the work or revising: Y.R., D.G.C., J.H., S.K., Y.L., E.J., J.M.K. Final approval of the manuscript: Y.R., D.G.C., J.H., S.K., Y.L., E.J., J.M.K.
Variable | Safety analysis set (n=3,185) |
---|---|
Sex | |
Female | 2,973 (93.3) |
Male | 212 (6.7) |
Age, yr | 68.9±9.9 |
<65 | 1,120 (35.2) |
65–74 | 1,010 (31.7) |
≥75 | 1,055 (33.1) |
BMI, kg/m2 | 22.5±3.3 |
History of fracturea | 1,413 (45.3) |
Prevalent vertebral fracture | 939 (30.1) |
Prevalent hip fracture | 236 (7.6) |
Prevalent other fracture | 454 (14.6) |
Diagnosis | |
Postmenopausal osteoporosis | 2,926 (91.9) |
Male osteoporosis | 211 (6.6) |
Bone loss due to AIT | 46 (1.4) |
Bone loss due to ADTb | 2 (0.06) |
Duration of osteoporosis, yr | |
<1 | 874 (27.4) |
≥1 to <5 | 1,127 (35.4) |
≥5 to <10 | 661 (20.8) |
≥10 | 468 (14.7) |
Unknown | 55 (1.7) |
History of medication use for osteoporosisa | |
Never usedc | 780 (25.0) |
Prior use or current use | 2,288 (73.4) |
Unknownd | 48 (1.5) |
History of BP usea | |
Not used | 1,277 (40.1) |
Previously used | 1,699 (53.3) |
Currently in use | 46 (1.4) |
Unknown | 94 (3.0) |
BMD T-scoree | |
Lumbar spine | −2.8±0.97 |
Total hip | −1.9±0.90 |
Femoral neck | −2.4±0.87 |
Values are expressed as number (%) or mean±standard deviation.
BMI, body mass index; AIT, aromatase inhibitor therapy; ADT, androgen deprivation therapy; BP, bisphosphonate; BMD, bone mineral density.
a Included in patients for whom information on previous medication use was available (n=3,116);
b One patient was incorrectly reported to be female;
c Defined “never used” in the history of osteoporosis medication as answered “never use” of BP and other medication in the medical history;
d Defined “unknown” as answered “unknown” of BP and other medication in the medical history;
e BMD data were analyzed in patients in the effectiveness analysis set for whom baseline and postbaseline BMD data were available (lumbar spine, n=1,423; total hip, n=1,222; femoral neck, n=1,362).
Variable |
Safety analysis set (n=3,185) |
|
---|---|---|
No. of patients (%) | No. of events | |
AEs | 613 (19.3) | 1,057 |
AEs leading to the discontinuation of denosumab | 36 (1.1) | 40 |
SAEs | 227 (7.1) | 295 |
Infections and infestationsa | 44 (1.4) | 49 |
Neoplasmsb | 18 (0.6) | 19 |
Cardiac disorders | 16 (0.5) | 18 |
Fatal AEsc | 26 (0.8) | 26 |
Most frequent AEs (>0.5%) | ||
Dizziness | 22 (0.7) | 25 |
Arthralgia | 21 (0.7) | 21 |
Back pain | 20 (0.6) | 21 |
Myalgia | 19 (0.6) | 19 |
Pneumonia | 17 (0.5) | 17 |
Headache | 16 (0.5) | 17 |
AEs of special interest | ||
Fracture | 40 (1.3) | 42 |
Musculoskeletal pain | 28 (0.9) | 28 |
Hypersensitivity | 20 (0.6) | 20 |
Hypocalcemia | 10 (0.3) | 11 |
Hyperparathyroidism tertiary | 1 (0.03) | 1 |
Fracture nonunion (delayed healing) | 1 (0.03) | 1 |
ADRs | 50 (1.6) | 62 |
Most frequent ADRs | ||
Myalgia | 10 (0.3) | 10 |
Paind | 9 (0.3) | 9 |
Hypocalcemia | 9 (0.3) | 10 |
Serious ADRs | 3 (0.09) | 4 |
Pneumonia | 2 (0.06) | 2 |
Vertebral compression fracture | 1 (0.03) | 2 |
AE, adverse event; ADR, adverse drug reaction; SAE, serious adverse event.
a Aspiration pneumonia was excluded;
b All benign tumors were excluded (e.g., uterine leiomyoma, thymoma);
c Other fatal AEs included sepsis in two patients and bacterial sepsis, pneumonia, septic shock, gastric cancer, Hodgkin’s disease, lung neoplasm malignant, metastatic gastric cancer, cardiac arrest, cardiac failure, Still’s disease, cerebral hemorrhage, chronic obstructive pulmonary disease, and thrombosis in one patient each;
d Includes general pains and shoulder and knee pains.
Variable |
Percent change in BMD, % |
P valuea | ||
---|---|---|---|---|
No. | Mean±SD | LS mean±SE | ||
Lumbar spine | ||||
Prior use of BP | ||||
Yes | 842 | 6.9±18.6 | 7.0±0.8 | 0.55 |
No | 581 | 7.9±29.4 | 7.7±1.0 | |
Total hip | ||||
Prior use of BP | ||||
Yes | 734 | 3.9±40.0 | 3.9±1.2 | 0.61 |
No | 488 | 3.0±8.2 | 3.0±1.4 | |
Femoral neck | ||||
Prior use of BP | ||||
Yes | 814 | 3.5±10.4 | 3.4±0.4 | 0.36 |
No | 548 | 2.8±11.3 | 2.9±0.4 |