Biomaterial Database

Risk factors for poor response to denosumab treatment in Japanese postmenopausal women with osteoporosis. 2022

Tokutaro Okawa, and Motomi Okawa, and Tatsuya Koike

Okawa Orthopaedic Surgery Hospital, Domyojimachi 6-12-34, Fujiidera, Osaka, 583-0012, Japan. tokawa12@kawachi.zaq.ne.jp.

BACKGROUND Denosumab has been reported to increase bone mineral density (BMD) and suppress fractures, but poor responders are not uncommon. This study aimed to identify risk factors for poor response to denosumab treatment. This is the first study to explore risk factors for poor response to denosumab. METHODS This retrospective observational study investigated 227 Japanese postmenopausal women who received denosumab with monitoring of BMD by dual-energy X-ray absorptiometry at 6-month intervals. Risk factors were identified using Cox's proportional hazard modeling. Poor responders were defined as not exceeding the least significant change of BMD from baseline for 3 years. RESULTS Mean relative change from baseline for 3 years in lumbar spine (LS)-BMD, femoral neck (FN)-BMD, and total hip (TH)-BMD were 12.6%, 6.8%, and 6.1%, respectively. Numbers of poor responders were 10 in LS-BMD, 47 in FN-BMD, 38 in TH-BMD. Risk factors for poor response were concomitant glucocorticoid use for LS-BMD, low body mass index or initiation at higher BMD for FN-BMD, and pretreatment with bisphosphonates or initiation at higher BMD for TH-BMD. CONCLUSIONS Risk factors for insufficient denosumab effect differed between BMD measurement sites. These results should be taken into consideration when selecting denosumab in clinical practice.

UI	MeSH Term	Description	Entries
D007564	Japan	A country in eastern Asia, island chain between the North Pacific Ocean and the Sea of Japan, east of the Korean Peninsula. The capital is Tokyo.	Bonin Islands
D010024	Osteoporosis	Reduction of bone mass without alteration in the composition of bone, leading to fractures. Primary osteoporosis can be of two major types: postmenopausal osteoporosis (OSTEOPOROSIS, POSTMENOPAUSAL) and age-related or senile osteoporosis.	Age-Related Osteoporosis,Bone Loss, Age-Related,Osteoporosis, Age-Related,Osteoporosis, Post-Traumatic,Osteoporosis, Senile,Senile Osteoporosis,Osteoporosis, Involutional,Age Related Osteoporosis,Age-Related Bone Loss,Age-Related Bone Losses,Age-Related Osteoporoses,Bone Loss, Age Related,Bone Losses, Age-Related,Osteoporoses,Osteoporoses, Age-Related,Osteoporoses, Senile,Osteoporosis, Age Related,Osteoporosis, Post Traumatic,Post-Traumatic Osteoporoses,Post-Traumatic Osteoporosis,Senile Osteoporoses
D005260	Female		Females
D006801	Humans	Members of the species Homo sapiens.	Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000069448	Denosumab	A humanized monoclonal antibody and an inhibitor of the RANK LIGAND, which regulates OSTEOCLAST differentiation and bone remodeling. It is used as a BONE DENSITY CONSERVATION AGENT in the treatment of OSTEOPOROSIS.	AMG 162,Prolia,Xgeva
D012307	Risk Factors	An aspect of personal behavior or lifestyle, environmental exposure, inborn or inherited characteristic, which, based on epidemiological evidence, is known to be associated with a health-related condition considered important to prevent.	Health Correlates,Risk Factor Scores,Risk Scores,Social Risk Factors,Population at Risk,Populations at Risk,Correlates, Health,Factor, Risk,Factor, Social Risk,Factors, Social Risk,Risk Factor,Risk Factor Score,Risk Factor, Social,Risk Factors, Social,Risk Score,Score, Risk,Score, Risk Factor,Social Risk Factor
D015519	Bone Density	The amount of mineral per square centimeter of BONE. This is the definition used in clinical practice. Actual bone density would be expressed in grams per milliliter. It is most frequently measured by X-RAY ABSORPTIOMETRY or TOMOGRAPHY, X RAY COMPUTED. Bone density is an important predictor for OSTEOPOROSIS.	Bone Mineral Content,Bone Mineral Density,Bone Densities,Bone Mineral Contents,Bone Mineral Densities,Density, Bone,Density, Bone Mineral
D015663	Osteoporosis, Postmenopausal	Metabolic disorder associated with fractures of the femoral neck, vertebrae, and distal forearm. It occurs commonly in women within 15-20 years after menopause, and is caused by factors associated with menopause including estrogen deficiency.	Bone Loss, Perimenopausal,Bone Loss, Postmenopausal,Perimenopausal Bone Loss,Postmenopausal Bone Loss,Postmenopausal Osteoporosis,Osteoporosis, Post-Menopausal,Bone Losses, Perimenopausal,Bone Losses, Postmenopausal,Osteoporoses, Post-Menopausal,Osteoporoses, Postmenopausal,Osteoporosis, Post Menopausal,Perimenopausal Bone Losses,Post-Menopausal Osteoporoses,Post-Menopausal Osteoporosis,Postmenopausal Bone Losses,Postmenopausal Osteoporoses
D017698	Postmenopause	The physiological period following the MENOPAUSE, the permanent cessation of the menstrual life.	Post-Menopause,Post-menopausal Period,Postmenopausal Period,Period, Post-menopausal,Period, Postmenopausal,Post Menopause,Post menopausal Period,Post-Menopauses
D050071	Bone Density Conservation Agents	Agents that inhibit BONE RESORPTION and/or favor BONE MINERALIZATION and BONE REGENERATION. They are used to heal BONE FRACTURES and to treat METABOLIC BONE DISEASES such as OSTEOPOROSIS.	Antiresorptive Agent,Antiresorptive Agents,Antiresorptive Drugs,Bone Resorption Inhibitors,Bone Resorption Inhibitory Agents,Agent, Antiresorptive,Inhibitors, Bone Resorption,Resorption Inhibitors, Bone