Primary Osteoporosis
Conditions
Interventions
FLS-CARE Group: Facilities confirmed to have implemented FLS based on OLS-7 select osteoporosis medications according to the 2025 Guidelines for Prevention and Treatment of Osteoporosis and goal-direc
Sponsors
Hagino Hiroshi
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: (1) Patients diagnosed with primary osteoporosis based on the diagnostic criteria of the Japanese Society for Bone and Mineral Research (2) Postmenopausal women aged 55 years and older at the time of consent acquisition (3) Outpatients capable of walking (4) Patients at high risk of fracture meeting any of the following criteria 1) to 4) 1) Patients with BMD at either the first to fourth lumbar vertebrae (L1-4) or second to fourth lumbar vertebrae (L2-4), femoral neck (FN), or total femoral shaft (TH) below 60% of peak bone mass (YAM) or below -3.3 SD. 2) Patients with two or more vertebral fractures between the fourth thoracic vertebra (Th4) and the fourth lumbar vertebra (L4), or with a Grade 3 vertebral fracture. 3) Patients with one or more fragility fractures and BMD at L1-4, L2-4, FN, or TH at or below 70% of YAM or -2.5 SD or below 4) Patients with a history of proximal femoral fracture
Exclusion criteria
Exclusion criteria: (1) Patients currently undergoing drug therapy for osteoporosis with bone-forming drugs (2) Patients diagnosed with secondary osteoporosis due to the following causes 1) Endocrine: Hyperparathyroidism, Hyperthyroidism, Hypogonadism in Youth, Premature Menopause, Cushing's Syndrome 2) Nutritional: Malabsorption syndrome, post-gastrectomy, anorexia nervosa, vitamin A or D toxicity, vitamin C deficiency 3) Drug-induced: Glucocorticoid preparations, drugs for hypogonadism therapy, selective serotonin reuptake inhibitors (SSRIs), others (warfarin, methotrexate, heparin, etc.) 4) Immobility: Systemic (bed rest, paraplegia, disuse syndrome, spaceflight), Localized (post-fracture, etc.) 5) Congenital: Osteogenesis imperfecta, Marfan syndrome 6) Other: Rheumatoid arthritis, diabetes, chronic kidney disease (CKD), liver disease, alcohol dependence (3) Patients with the following diseases presenting bone loss other than osteoporosis Osteomalacia, bone metastases from malignant tumors, multiple myeloma, vertebral hemangioma, vertebral caries, pyogenic spondylitis, Paget's disease of bone, fibrous dysplasia, ankylosing spondylitis, hypophosphatasia (4) Patients with hypercalcemia or hypocalcemia (5) Hospitalized patients requiring prolonged bed rest [However, short-term hospitalization due to acute symptoms, etc., is acceptable] (6) Patients with a constitution prone to hypersensitivity reactions such as bronchial asthma or rashes (erythema, urticaria, etc.) (7) Patients with malignant tumors undergoing treatment (8) Patients contraindicated for the treatment drug (9) Based on the "Important Basic Precautions" section of the "Ibenity" package insert, patients who should avoid administration of romosozumab (patients with a history of ischemic heart disease or cerebrovascular disorder within the past year, etc.) (10) Patients with severe renal, hepatic, or cardiac disease (11) Patients with dementia deemed inappropriate for study participation by the principal (responsible) investigator (12) Other patients deemed inappropriate for study participation by the principal (responsible) investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence rate of new vertebral fractures (number of fractures per person-year) (12 months) | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence rate of new vertebral fractures (number of fractures per person-years) (24 months) Proportion of adherence (MPR 2/3 or less) (6, 12, 24 months) Treatment Continuation Rate (6, 12, 24 months) Incidence of new non-vertebral fractures (12 months, 24 months) Worsening of vertebral fracture SQ grade (12 months, 24 months) Change rate in BMD at L1-4 or L2-4, FN, TH (6, 12, 24 months) Percentage of cases with BMD at L1-4 or L2-4 and TH exceeding a T-score of -2.5 (12, 24 months) Percentage of patients reaching the STE (Surrogate Threshold Effect) predicting a reduction in the risk of all /vertebral/non-vertebral/proximal femur fractures (12, 24 months) | — |
Contacts
Public ContactHiroaki Suzuki
Public Health Research Foundation
Outcome results
None listed