Osteoporosis
Conditions
Interventions
IBN group: IBN will be intravenously administered once a month at a dose of 1 mg.
Another BPs
Sponsors
MOVEMENT Study Protocol Review Committee (executive committee)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Those who are diagnosed with primary osteoporosis in accordance with the diagnostic guidelines for primary osteoporosis established by the Japanese Society for Bone and Mineral Research (revised in 2012) and fulfill the following criteria will be eligible for the study: 1) Those who have been treated with oral BP for at least one to less than three years (Response to a questionnaire about medications states that treatment with oral BP has been provided and that the medication adherence rate for the past one year was more than 75%.) 2) Lumbar spine (L1-4 or L2-4) bone mineral density shows a decreasing trend 3) Aged 50 years or more when providing informed consent 4) Provided written informed consent at the time of participation in the study
Exclusion criteria
Exclusion criteria: 1) Patients with secondary osteoporosis 2) Lumbar spine bone mineral density (L1-4 or L2-4) T-score<-4.0 L1-4: <0.453 g/cm2 for males and <0.541 g/cm2 for females L2-4: <0.500 g/cm2 for males and <0.534 g/cm2 for females 3) There are findings that may affect the measurement of bone mineral density using DXA. 4) There are at least two fractures in L1-4. 5) Any of the following drugs was administered within eight weeks before enrollment: SERM preparation, sex hormone preparation, adrenal corticosteroid preparation, insulin preparation 6) Any of the following drugs was administered within one year before enrollment: PTH preparation, anti-RANKL antibody preparation, anti-sclerostin antibody preparation, cathepsin K inhibitors, zoledronic acid hydrate, alendronate sodium hydrate, and intravenous fluid preparation 7) Has received intravenous IBN administration 8) Corrected serum Ca level at enrollment is less than 8.4 mg/dL 9) Women who are, are likely to be, or want to become pregnant 10) Those who have a severe heart disease, kidney disease, or liver disease 11) Those who are hypersensitive for BP preparations 12) Those who have active malignant tumor 13) Those who are ineligible for the study judged by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in bone mineral density (lumbar spine) from the baseline in the IBN group (at 12 months after start of treatment) | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in bone mineral density (Femur) and bone turnover markers Responder of bone mineral density (lumbar spine) Comparison between IBN group and observation group | — |
Countries
Japan
Contacts
Public ContactNaoko Kojima
Mebix, Inc. Research promotion division
Outcome results
None listed