Primary osteoporosis
Conditions
Interventions
Abaloparatide group, Alendronate group
Sponsors
Mawatari Taro
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Eligible patients are those who meet all of the inclusion criteria listed below: (1) Diagnosed with primary osteoporosis according to the diagnostic criteria of the Japanese Society for Bone and Mineral Research (year 2012 revision) (2) Postmenopausal women aged 55 years or older (3) Ambulatory outpatients (4) Patients who can take CT images of the femur and vertebrae (5) Patients who can measure bone mineral density at the lumbar vertebrae L1-L4 and femur (6) Patients who meet any of the following criteria 1) to 4) 1) Less than 60% or less than -3.3SD of the young adult mean in bone mineral density 2) Have more than 2 vertebral fractures or Grade 3 fracture 3) Have 1 or more vertebral fractures and with less than 70% or less than -2.5SD in bone mineral density 4) Have a history of femoral neck fracture
Exclusion criteria
Exclusion criteria: Patients who meet any of the following criteria will be excluded from participating in the study: (1) Diagnosed with secondary osteoporosis caused by below-listed disorders: 1) Endocrine disorders: hyperparathyroidism, hyperthyroidism, juvenile gonadal failure, early menopause, cushings syndrome 2) Nutritional disorders: malabsorption syndrome, postgastrectomy, anorexia nervosa, hypervitaminosis A or D, vitamin C deficiency 3) Medication: steroid, sex hormone lowering drug, Selective Serotonin Reuptake Inhibitor (SSRI) etc. 4) Immobility: systemic immobility, local immobility 5) Congenital disorders: osteogenesis imperfecta, Marfans syndrome 6) Other disorders: rheumatoid arthritis, diabetes, chronic kidney disease (CKD), hepatic disorders, alcohol dependence syndrome (2) Diagnosed with below-listed disorders causing a decrease in bone mass, other than osteoporosis: osteohalisteresis, bone metastasis, multiple myeloma, vertebral hemangioma etc. (3) Patients in whom CT images of the femur and vertebrae cannot be taken 1) With irremovable metal in the body 2) Using a cardiac pacemaker (4) Patients with the following X-ray findings that may affect the strength of the vertebral body: 1) 6 or more consecutive vertebral bodies form a bridge 2) Ossification is observed in the ligaments around the vertebral body 3) With significant spinal deformity 4) Undergone surgery on the vertebral body (5) Patients who have used the following drugs that affect calcium or bone metabolism: 1) BPs preparations or anti-RANKL monoclonal antibodies within 3 years prior to the registration 2) Following drugs within 26 weeks (182 days) prior to the registration: Anabolic steroid preparations, progesterone preparations, mixed hormone preparations, male hormone preparations, corticosteroids (excluding local preparations such as intra-articular injections, topical skin preparations, inhalation, and eye drops) 3) Following drugs prior the registration or who have participated in other clinical trials: (excluding patients confirmed to have received placebo) PTH preparations, cathepsin K inhibitors, Ca-sensing receptor agonists, anti-sclerostin antibodies (6) Hospitalized patients [However, short-term hospitalization due to acute symptoms is acceptable] (7) With a constitution that is prone to hypersensitivity symptoms such as bronchial asthma and rashes (erythema, wheals, etc.) (8) Medical interviews are deemed unreliable, such as those diagnosed with dementia (9) With malignant tumors currently undergoing treatment (10) Test drug to be used is contraindicated (11) Serious kidney disease, hepatic disease, or cardiac disease (12) Judged ineligible by physician-in-charge to participate in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change of bone strength in femoral and vertebra bone at 78 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Achievement rate of femoral bone strength standard (78 weeks) Bone strength related index volumetric bone mineral density by BCT (78 weeks) Incidence of vertebral fracture (78 weeks) Progression of vertebral fracture SQ grade (78 weeks) Incidence of non vertebral fracture (78 weeks) Changes of bone mineral density (78 weeks) Changes of bone metabolism markers | — |
Contacts
Public ContactYuko Iwata
Public Health Research Foundation
Outcome results
None listed