Primary osteoporosis
Conditions
Interventions
Eldecalcitol 0.75ug/day (28 days)
Alfacalcidol 1ug/day (28 days)
Native vitamin D 800IU/day (28days)
Non-treatment group (28 days)
Sponsors
Research secretariat (IDD, Inc.)
Kazuhiro Uenishi Professor, Laboratory of Physiological Nutrition, Kagawa Nutrition University
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Subject with postmenopausal primary osteoporosis. 2) Subject with major osteoporotic fracture risk is 10% or more and less than 25% by FRAX at screening examination. 3) Subject with 60 years old or more and 80 years old or less. 4) Subject with a written consent to participation in this study by their free will.
Exclusion criteria
Exclusion criteria: 1) Has a history of fragility fracture within a year. 2) Has complication or using medicines as follows. 1. Endocrine disease 2. Malignancy 3. Poor nutrition (undernourishment) 4. Gout 5. Lactose intolerance 3) Has gastric resection or gastric bypass surgery. 4) Has taken bisphosphonate medicine (included investigational new drug) within 6 months before starting of dosing. 5) Has taken RANKL antibody in the past at a time. 6) Has taken following medications effected to born metabolism within 4 weeks before dosing. 1. Selective estrogen receptor modulators formulation 2. Calcitonin preparation 3. Vitamin K2 preparation 4. Ipriflavone preparation 5. Sex hormone preparation (without tablet or cream vaginal agents) 6. Active vitamin D3 preparation 7. Native vitamin D preparation 8. Ca preparation 9. Other drug or supplement those effect to born metabolism. 7) Has taken following drugs effected to Ca absorption and elimination within 4 weeks before dosing. 1. Steroid preparation (excluded external preparation and local injection with inhalation, nasal preparation) 2. Other drugs or supplements effected to Ca absorption and elimination. 8) Has taken parathyroid hormone preparation in the past at a time. 9) Has taken anti- sclerostin antibody or cathepsin K-inhibitor in the past at a time. 10) Has taken other investigational new drug (included placebo) within 16 weeks before dosing. 11) Has caught extreme rays by sunbath at a resort within a month before dosing. 12) Serum Ca at the registration is more than 10.4 mg/dL or less than 8.0 mg/dL. 13) Urine Ca is over than 0.4 mg/dL GF. 14) Has currently or a history of urinary tract stone. 15) eGFR at registration is less than 30mL/min/1.73m2. 16) Has advanced liver disease like cirrhosis or advanced heart disease like serious heart failure. 17) Has hypersensitivity to ELD, ALF or other vitamin D preparation. 18) Other people who are judged by the investigator or the subinvestigator as inappropriate to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Efficacy Percent change of calcium absorption from baseline in the ELD group. 2. Safety Summarizing and aggregation of number and frequency of all adverse events occurring. The point of assessment for efficacy and safety is 28 days after starting administration. | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy 1) Secondary outcomes 1. Percent change of calcium absorption from baseline in groups without ELD group. 2. Comparison the percent change of calcium absorption from baseline between groups. 3. Comparison the ratio of calcium absorption from baseline between groups. 4. Comparison the ratio of calcium absorption at final dosing between groups. 2) Other outcomes 1. Percent change of uNTX from baseline in groups 2. Comparison the percent change of uNTX from baseline between groups. 3. Change of calcium and phosphorus regulation-hormones (25(OH)D, 1,25(OH)2D, intact-PTH, FGF23) from baseline in the group. 4. Comparison calcium and phosphorus regulation-hormones at the pre-dosing and post-dosing between groups. 5. Relationship between subjects' background of screening or pre-dosing examination or calcium related test items and calcium absorption ratio from intestine. 6. Relationship between subjects' background of screening or pre-dosing examination or calcium related test items and percent change of calcium absorption ratio from intestine. 7. Relationship between calcium related test items or calcium and phosphorus regulation-hormones and change in intestinal calcium absorption ratio between pre-dosing and post-dosing in each group. | — |
Countries
Japan
Contacts
Public ContactYasuo Mabuchi
IDD, Inc. Business Planning Office; Foreign Affairs Dept.
Outcome results
None listed