Osteoporosis
Conditions
Keywords
AK156
Brief summary
The purpose of this study is to investigate the efficacy and safety of AK156 in Japanese patients with primary osteoporosis.
Interventions
DRUGAK156
zoledronic acid (i.v.)/year + daily calcium and vitamin D for 2 years
DRUGPlacebo
placebo (i.v.)/year + daily calcium and vitamin D for 2 years
Sponsors
Asahi Kasei Pharma Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to 89 Years
Healthy volunteers
No
Inclusion criteria
* Patients diagnosed with primary osteoporosis * Patients who have vertebral fractures at the time of screening
Exclusion criteria
* Patients diagnosed with secondary osteoporosis * Patients with a current uncontrolled medical disorder or other condition which makes the patient unsuitable for the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| New vertebral fractures | 2 Years | Reduction in the incidence rate of new fragility vertebral fractures |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Vertebral fractures (worsening and new) | 2 Years | The incidence rate of fragility vertebral fractures (worsening and new) |
| Clinical fractures | 2 Years | The incidence rate of Clinical fractures |
| Bone mineral density | 2 Years | The percent change from baseline in bone mineral density of lumbar spine and hip |
| Bone metabolic marker | 2 Years | The percent change from baseline in bone metabolic marker |
Countries
Japan
Outcome results
None listed