primary osteoporosis
Conditions
Interventions
Randomized into daily- and twice-weekly Teriparatide self-administration
groups
Sponsors
Soen Satoshi
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Eligible patients are those who have given written consent to participate in the study and 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) Japanese aged 60 years and older at the time of consent (3) Postmenopausal women (4) Able to visit a hospital for treatment (5) Able to self-administer medications (6) Able to comprehend and answer the contents of the patient questionnaire (7) Patients who meet any of the following conditions: 1 Less than 60% or -3.3SD of YAM in bone density 2 Have more than 2 vertebral body fractures between the fourth thoracic vertebrae (Th4) and the fourth lumbar vertebrae (L4) 3 Have grade 3 bone fractures 4 Have 1 or more vertebral body fractures between the fourth thoracic vertebrae (Th4) and the fourth lumbar vertebrae (L4), with less than -2.5 SD of YAM in bone density 5 Have a history of proximal thighbone 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), other drugs (Warfarin, Methotrexate, Heparin, etc.) 4 Immobility: systemic immobility (best rest, paraplegia, disuse syndrome, space travel), local immobility (after bone fracture, etc.) 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,: 1 Osteohalisteresis 2 Bone metastasis 3 Multiple myeloma 4 Vertebral hemangioma 5 Pott disease 6 Vertebral osteomyelitis 7 Other (3) Likely to develop hypersensitive reactions such as bronchial asthma, rash (erythema, pomphus, etc.) (4) Patients with contraindications for use of teriparatide acetate (Excerpts from package insert of teriparatide): 1 Patients at increased baseline risk of osteosarcoma with: a. Pagets disease of bone b. Unexplained elevations of alkaline phosphatase c. Pediatric and young adult patients with open epiphyses d. Prior radiation therapy involving the skeleton 2 Hypercalcemia 3 Primary bone cancer or bone metastasis 4 Metabolic bone disease other than osteoporosis (hyperparathyroidism, etc.) 5 Prior hypersensitive reactions to teriparatide 6 Pregnant or suspected of being pregnant (Excerpts from package insert of genetically engineered versions of teriparatide) 1 Patients at increased baseline risk of osteosarcoma with: a. Pagets disease of bone b. Unexplained elevations of alkaline phosphatase c. Pediatric and young adult patients with open epiphyses d. Prior radiation therapy involving the skeleton 2 Hypercalcemia 3 Primary bone cancer or bone metastasis 4 Metabolic bone disease other than osteoporosis (hyperparathyroidism, etc.) 5 Prior hypersensitive reactions to teriparatide 6 Pregnant or suspected of being pregnant (5) Serious kidney disease, hepatic disease, or cardiac disease 1 Kidney disease: serum creatinine level >= 2mg/dL 2 Hepatic disease: AST(GOT) or ALT(GPT) level is more than 2.5 times the upper limit of the baseline, or more than 100 IU/L 3 Cardiac disease: cases corresponding to Grade 2 or higher as defined in Concerning classification criteria for seriousness of adverse drug reactions of medical agents (6) Unable to self-administer medications (7) Prior self-administration of insulin or anti-rheumatoid drugs (8) Dementia patients with whom medical interviews are difficult to conduct (9) Patients treated with osteoporosis medications within 52 weeks (364 days) before consent is given (if dosing interval is defined in dosage regimen, adding the time interval to 52 weeks (364 days) is required.) (10) Hospitalized patients (11) Prior treatment with teriparatide (12) Judged ineligible by physician-in-charge to participate in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patient satisfaction rate (26 weeks (about 6 months)) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1 Patient satisfaction rate 52 wks and 104 wks 2 Theatment satisfaction rate at 26 wks, 52 wks, and 104 wks 3 Preference of free-choice 4 Mwdication adherence = adhierent (>= 80% adherence) and continuing treatment (>= 50% adherence at the last month, and final hospital vist within a designated period) 5 Clinical fracture, change in bone density and QOL (VAS , EQ-5D), and bone structure analysis | — |
Contacts
Public ContactMasafumi Mori
Public Health Research Foundation
Outcome results
None listed