Primary Osteoporosis
Conditions
Interventions
Administration of Ibandronate 1 mg / month, Calcium preparations (combination drug) (New Calcium D 3) for 12 months to 66 patients with primary osteoporosis who had been treated with teriparatide for
Sponsors
Osaki Makoto
Chiba Ko
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1.Patients who underwent teriparatide treatment for primary osteoporosis for 12 consecutive months or more (confirmed compliance with over 75% during the period) 2.Patients who can receive ibandronate within 8 weeks from the final administration of teriparatide 3.Age: Patients over 55 years old 4.Gender: female 5.Outpatient 6.After receiving sufficient explanation for participation in this study, patients who gained written consent by the patient's free will with sufficient understanding
Exclusion criteria
Exclusion criteria: 1.Patients with the following underlying diseases: Serious heart disease, liver disease, renal disorder, diabetes, active malignant tumor Endocrine, metabolic diseases affecting bone metabolism Secondary osteoporosis (steroid, rheumatoid arthritis, immobility) 2.Patient with the following medication Steroid: 5 mg or more Use experience of 3 months or more (excluding inhaled steroids) Agents affecting bone metabolism (drugs for malignant tumor etc.) 3.Patient falling under any of the contraindication items of drugs used: Patients with a history of hypersensitivity to components of ibandronate formulation or other bisphosphonate drugs Patients with hypocalcemia 4.Patients who participated in the clinical trial within 4 months 5.Patients who were confirmed to have three or more existing fractures in the first to fourth lumbar vertebrae by X-ray radiophotography during the observation period 6.In addition, patients whose research managers judged inappropriate as research subjects
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change rate of lumbar spine bone mineral density from before administration to 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Change rate of lumbar spine bone mineral density from before administration to 6 months. 2) Change rate of femur / radial bone mineral density (aBMD), calcaneous SOS, occurrence rate of vertebral body fracture, bone metabolism marker, rate of change of VAS, cortical bone structure, Cancellous bone structure, bone morphology, change rate of predicted bone strength, lumbar / femoral bone density (vBMD), rate of change of femoral bone morphology, blood test. | — |
Contacts
Public ContactKo Chiba
Nagasaki University Graduate School of Biomedical Sciences
Outcome results
None listed