Osteoporosis
Conditions
Keywords
The changes of bone mineral density and bone turnover markers
Brief summary
In the patients with osteoporosis, bisphosphonates (BPs) are a golden standard treatment. However, the bone turnover markers or the bone mineral density (BMD) are not improved in some osteoporotic patients even though they have taken BPs and alfacalcidol more than several years. In those case, the investigators better off prescribing BPs and Eldecalcitol, instead of BPs and Alfacalcitol.
Detailed description
Alfacalcitol and Eldecalcitol are the similar vitamin D drugs. However, Eldecalcitol is an improved vitamin D drug than Alfacalcitol. Therefore, we investigate the effectiveness of Eldecalcitol in this study.
Interventions
DRUGEdirol
Edirol 0.5 or 0.75ug once every day oral treatment for at least 1 year after initial visit.
Sponsors
Shinshu University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
* Clinical diagnosis of Osteoporosis * Must be able to swallow tablets
Exclusion criteria
* N/A
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with bone turnover markers as a Measure of bone quality | At 4 months after the initial treatment | Bone formation and bone absorption markers will be evaluated at each time point |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with bone mineral density as a Measure of bone quality | At 4 months after the initial treatment | Bone mineral density will be evaluated at each time point |
Countries
Japan
Contacts
Primary ContactYukio Nakamura, MD, PhD
Outcome results
None listed