osteoporosis
Conditions
Interventions
Teriparatide Acetate
Teriparatide (Genetical Recombination)
Sponsors
Saitama Medical University
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Post-menopausal women of 60-y-o or above with sever osteoporosis who have a fresh vertebral fracture and understand, and literary approve to be included to this study. #1; The fresh vertebral fracture, what occur during 2 weeks, is defined with history, physical examination and X-ray appearances and/or MRI of spine. #2; The sever osteoporosis is diagnosed to a patient whose point is accounting for 3 or above by our appraisal standard as follow. Point 70%YAM>BMD=/>65% 1 65%YAM>BMD=/>60% 2 60%YAM>BMD 3 New vertebral fracture 1 Using corticosteroid 1 Old vertebral fracture =1 1 Old vertebral fractures >1 2 Sever osteoporosis: total 3=/<
Exclusion criteria
Exclusion criteria: 1. Patients in whom study drugs (teriparatide) are contraindicated 2. Serious renal, hepatic, or cardiac disease 3. Secondly osteoporosis 4. Patients who are considered inappropriate for enrollment by the investigator for any other reason
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bone metabolic markers | — |
Secondary
| Measure | Time frame |
|---|---|
| Vertebral and femoral bone mineral density, numbers of new vertebral fractures during the study period, VAS, JOQOL, RDQ, QUEST, and bony union | — |
Countries
Japan
Contacts
Public ContactShinya Tanaka
Saitama Medical University Department of Orthopaedic Surgery
Outcome results
None listed