Primary Osteoporosis
Conditions
Sponsors
CHUGAI PHARMACEUTICAL CO., LTD
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Each subject must have met all of the following inclusion criteria to be the subject in this study: 1) By dual energy X ray absorptiometry (DXA) for the lumbar spine at screening, patients with primary osteoporosis meet the following criteria. Patients with history of fragility fracture*, T score of the bone mineral density of the lumbar spine (L1-4 BMD) is -1.0 SD** or less Patients without history of fragility fracture, T score of the bone mineral density of the lumbar spine (L1-4 BMD) is -2.5 SD** or less *: Fragility fracture is the fracture caused by slightly external force, due to low bone mass. This study is only limited to fragility fracture of vertebral (4 th to 12th thoracic vertebrae) and femur, humerus, forearm occurred after age 50 and later. **: Using BioClinica's center to analyze bone mineral density. 2) Although there is no gender limit, female patients should be postmenopausal for 3 or more years. When menopause is unknown, subjects should be 60 years old or older. 3) Outpatients who are able to walk. 4) Patients who can understand the informed consent form, participate in this study voluntarily, and have signed the inform consent by themselves or their legal representatives.
Exclusion criteria
Exclusion criteria: Subjects meeting any of the following exclusion criteria will not to be included in this study. (1) Patients having any of the following history of usage of bisphosphonate formulations Patients who received oral bisphosphonate formulations once or more times within 2 months prior to screening, Patient who recieved oral bisphosphonate fomulations for 4weeks or longer within 1 year prior to screening. For non-continuous oral administration preparation, the dosing interval will be considered as administration time. (eg, preparation for once a week, the one time of administration should be 1 week). Patients who used oral bisphosphonate formulations once or more times for the purpose other than the treatment of osteoporosis. Patients who were injected bisphosphonate formulations once or more times. (2) Within 2 months prior to screening, patients who received following treatment of drugs which may affect bone metabolism (except for calcium preparations) Active vitamin D3 preparations (including external medicine) Vitamin K2 preparation Calcitonin preparations Selective estrogen receptor modulators Sex hormone preparations (excluding vaginal tablets, creams etc) Adrenocorticotropic hormone (excluding inhaler, nasal administrations, other external medicine and local injections) GnRH-a preparations Antiestrogen preparations Cyclosporine (3) Patients who used following drugs: Parathyroid hormone preparation Anti-RANKL antibody Cathepsin K inhibitors Strontium preparations Anti-Sclerostin antibody (4) Within 4 months prior to screening, patients who received treatment of other investigatory drugs (including placebo) (5) Patients who are currently receiving thyroid hormone replacement therapy, and their TSH less than 0.1micro-U/mL within 3 months prior to obtaining their informed consent (6) Patients with history of gastrectomy (2/3 and more), extensive small bowel resection etc. (7) Patients with diseases causing decreased bone mass, other than primary osteoporosis 1) Secondary osteoporosis I) Endocrine: gonadal dysfunction, hyperthyroidism, Cushing's syndrome II) Nutrition: vitamin C deficiency, protein deficiency, vitamin A or vitamin D intoxication III) Drugs: methotrexate (MTX), heparin IV) Disuse: systemic (bedridden, paralyzed) V) Congenital: osteogenesis imperfecta, Marfan syndrome etc VI) Other: rheumatoid arthritis, poorly controlled diabetes (HbA1c: >= 9%) 2) Other diseases causing low bone mass I)Various osteomalacia II)Primary, secondary hyperparathyroidism III)Bone metastasis of malignant tumors IV)Multiple Myeloma V)Others (8) Patients who have following condition can impact the DXA evaluation of bone mineral density of lumbar spine: Patients with severe deformation or fracture of L1-4 vertebral body Patients with severe degeneration or bone sclerosis image of L1-4 vertebral body Patients with highly extrapyramidal calcified image, which overlaps with L1-4 vertebral body Patients with other abnormalities which might affect examination of bone mineral density of the lumbar spine (9) Patients with the sCr value exceeds the upper limit of the normal range of the center at screening (10) Patients with adjusted sCr value exceeds 2.59 mmol/L (10.4 mg/dL) at screening or uCa/uCr value exceeds 0.4 at screening (11) Patients having urinary tract calculi by B-mode ultrasonography examination at screening or history of urinary tract calculi (12) Patients with severe liver disease such
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy Rate of change of bone density of lumbar spine(L1-4 BMD) from baseline values 12 months later Time distribution of rate of change of bone density of lumbar spine(L1-4 BMD) from baseline values 12 months later | — |
Secondary
| Measure | Time frame |
|---|---|
| safety efficacy Time distribution of rate of change of total hip BMD from baseline values Time distribution of rate of change of bone metabolism markers from baseline values | — |
Countries
Asia except Japan
Outcome results
None listed