Quantitative assessment of the eldecalcitol effect on intestinal calcium absorptio

Not Applicable

• Conditions: Primary osteoporosis

• Registration Number: JPRN-UMIN000020267
• Lead Sponsor: Research secretariat (IDD, Inc.)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-12-19
• Study Completion: 2016-03-16
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified