The Effect of Inactive and Active Vitamin D on Serum Sclerostin/dickkopf1 Levels

Osteoporosis Clinical Trial

Official title:

Comparisons of the Effect of Inactive and Active Vitamin D on Serum Sclerostin/dickkopf1 Levels

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01765010
• Other study ID #: SNUH-ENDO-2013
• Status: Recruiting
• Phase: Phase 4
• First received: January 8, 2013
• Last updated: January 8, 2013
• Start date: January 2013
• Est. completion date: March 2013

Study information

• Verified date: January 2013
• Source: Seoul National University Hospital
• Contact: Chan Soo Shin, MD, PhD
• Phone: +82-2-2072-3734
• Email: csshin[@]snu.ac.kr
• Is FDA regulated: No
• Health authority: Korea: Food and Drug AdministrationKorea: Ministry for Health and Welfare
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the effect of inactive and active vitamin D on serum sclerostin and dickkopf1 levels.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 88
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 40 Years

Eligibility

Inclusion Criteria:

• Healthy male volunteer older than 20 years

Exclusion Criteria:

• Subjects with bone and mineral metabolism disorders

• Subjects with kidney or liver diseases

• Subjects with uncorrectable hypercalcemia or hypocalcemia

• Subjects with chronic gastrointestinal disorders or malabsorption

• Subjects taking medication related to bone loss

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoporosis

Intervention

Drug:
• Calcitriol

• Alfacalcidol

• Cholecalciferol

• Placebo

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Medical School	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of serum sclerostin level		8 weeks later	No
Primary	Change of serum Dickkopf1 level		8 weeks later	No
Secondary	Change of serum c-telopeptide level		8 weeks later	No
Secondary	Change of serum bone-specific alkaline phosphatase level		8 weeks later	No
Secondary	Change of serum calcium level		8 weeks later	Yes
Secondary	Change of serum parathyroid hormone level		8 weeks later	No