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

Primary Purpose

Osteoporosis

Status

Unknown status

Phase

Phase 4

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Calcitriol

Alfacalcidol

Cholecalciferol

Placebo

About this trial

This is an interventional treatment trial for Osteoporosis focused on measuring Vitamin D, Serum sclerostin, Serum dickkopf1

Eligibility Criteria

20 Years - 40 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

Seoul National University Medical SchoolRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Active Comparator

Experimental

Arm Label

Placebo control

Cholecalciferol 1000IU

alfacalcidol

Calcitriol

Arm Description

Placebo control

Cholecalciferol 1000IU qd for 8 weeks

alfacalcidol 0.5ug qd for 8 weeks

Calcitriol 0.25ug qd for 8 weeks

Outcomes

Primary Outcome Measures

Change of serum sclerostin level

Change of serum Dickkopf1 level

Secondary Outcome Measures

Change of serum c-telopeptide level

Change of serum bone-specific alkaline phosphatase level

Change of serum calcium level

Change of serum parathyroid hormone level

Full Information

NCT ID

NCT01765010

First Posted

January 8, 2013

Last Updated

January 8, 2013

Sponsor

Seoul National University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01765010

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2013

Overall Recruitment Status

Unknown status

Study Start Date

January 2013 (undefined)

Primary Completion Date

March 2013 (Anticipated)

Study Completion Date

March 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Seoul National University Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoporosis

Keywords

Vitamin D, Serum sclerostin, Serum dickkopf1

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Factorial Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

88 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Placebo control

Arm Type

Placebo Comparator

Arm Description

Placebo control

Arm Title

Cholecalciferol 1000IU

Arm Type

Active Comparator

Arm Description

Cholecalciferol 1000IU qd for 8 weeks

Arm Title

alfacalcidol

Arm Type

Experimental

Arm Description

alfacalcidol 0.5ug qd for 8 weeks

Arm Title

Calcitriol

Arm Type

Experimental

Arm Description

Calcitriol 0.25ug qd for 8 weeks

Intervention Type

Drug

Intervention Name(s)

Calcitriol

Other Intervention Name(s)

Calcio

Intervention Type

Drug

Intervention Name(s)

Alfacalcidol

Other Intervention Name(s)

Onealfa

Intervention Type

Drug

Intervention Name(s)

Cholecalciferol

Other Intervention Name(s)

DicamaxD

Intervention Type

Drug

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

Change of serum sclerostin level

Time Frame

8 weeks later

Title

Change of serum Dickkopf1 level

Time Frame

8 weeks later

Secondary Outcome Measure Information:

Title

Change of serum c-telopeptide level

Time Frame

8 weeks later

Title

Change of serum bone-specific alkaline phosphatase level

Time Frame

8 weeks later

Title

Change of serum calcium level

Time Frame

8 weeks later

Title

Change of serum parathyroid hormone level

Time Frame

8 weeks later

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Chan Soo Shin, MD, PhD

Phone

+82-2-2072-3734

csshin@snu.ac.kr

First Name & Middle Initial & Last Name or Official Title & Degree

Jung Hee Kim, MD

Phone

+82-2-2072-4839

jhkxingfu@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Chan Soo Shin, MD, PhD

Organizational Affiliation

Seoul National University Medical School

Official's Role

Principal Investigator

Facility Information:

Facility Name

Seoul National University Medical School

City

Seoul

ZIP/Postal Code

110-744

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Chan Soo Shin, MD, PhD

Phone

82220723734

csshin@snu.ac.kr

First Name & Middle Initial & Last Name & Degree

Jung Hee Kim, MD

Phone

8220724839

jhkxingfu@gmail.com

First Name & Middle Initial & Last Name & Degree

Chan Soo Shin, MD, PhD

12. IPD Sharing Statement

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

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