Primary osteoporosis
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1) Primary osteoporosis patients with one or more previous fragility fractures (e.g., proximal femoral fracture, vertebral fracture, distal radius fracture, proximal humerus fracture, rib fracture, pelvic fracture, lower leg fracture) 2) A written informed consent for the participation in the study
Exclusion criteria
Exclusion criteria: 1)Patients with serious cardiac disorder, serious liver dysfunction, serious kidney dysfunction, diabetes mellitus, endocrine and metabolic diseases which may affect to the bone metabolism, and secondary osteoporosis (e.g., glucocorticoid-induced osteoporosis, rheumatoid arthritis, immobilization osteoporosis) 2)Patients treated with medication which affect to the bone metabolism as follows, i)Glucocorticosteroids (within 6 months before enrollment, or >5mg for over 3 months) except inhaler or nasal drip ii)Anti-cancer drugs iii)Anti-osteoporosis drugs (teriparatide, anti-RANKL antibody, bisphosphonates within 6 months before enrollment, SERMs within 3 months before enrollment, or estrogen preparations) 3)Patients who have contraindication of teriparatide or bisphosphonate 4)Patients who have severe allergy 5)Patients enrolled in other clinical studies in the past 3 months. 6)Patients judged to be inadequate for this study by investigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of cortical thickness changes after 18 months | — |
Secondary
| Measure | Time frame |
|---|---|
| The change of bone mineral density, bone microarchitecture, geometry and strength after 18 and 24 months | — |
Countries
Japan
Contacts
Nagasaki University Hospital Department of orthopaedic surgery