OsteoporosisPhase 4NCT01765010
The Effect of Inactive and Active Vitamin D on Serum Sclerostin/dickkopf1 Levels
A Phase 4 study testing Calcitriol, Alfacalcidol and Cholecalciferol in people with Osteoporosis, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to compare the effect of inactive and active vitamin D on serum sclerostin and dickkopf1 levels. Read more about this study
- Who is it for?
- Ages 20 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis
- What is being tested?
- Calcitriol, Alfacalcidol and Cholecalciferol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2013to Mar 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male volunteer older than 20 years
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Medical School
Seoul, 110-744
Chan Soo Shin, MD, PhD, 82220723734, csshin@snu.ac.kr
Jung Hee Kim, MD, 8220724839, jhkxingfu@gmail.com
About this study
Official title: Comparisons of the Effect of Inactive and Active Vitamin D on Serum Sclerostin/dickkopf1 Levels
The purpose of this study is to compare the effect of inactive and active vitamin D on serum sclerostin and dickkopf1 levels.
- Conditions
- Osteoporosis
- Being tested
- Calcitriol, Alfacalcidol, Cholecalciferol, Placebo
- Keywords
- Vitamin D, Serum sclerostin, Serum dickkopf1
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CalcitriolDrug
Also called Calcio
AlfacalcidolDrug
Also called Onealfa
CholecalciferolDrug
Also called DicamaxD
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Placebo control | Placebo comparator | Placebo control Receives: Drug: Placebo |
| Cholecalciferol 1000IU | Active comparator | Cholecalciferol 1000IU qd for 8 weeks Receives: Drug: Cholecalciferol |
| alfacalcidol | Experimental | alfacalcidol 0.5ug qd for 8 weeks Receives: Drug: Alfacalcidol |
| Calcitriol | Experimental | Calcitriol 0.25ug qd for 8 weeks Receives: Drug: Calcitriol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of serum sclerostin level
Measured: 8 weeks later
Change of serum Dickkopf1 level
Measured: 8 weeks later
Secondary outcomes (4)
Change of serum c-telopeptide level
Measured: 8 weeks later
Change of serum bone-specific alkaline phosphatase level
Measured: 8 weeks later
Change of serum calcium level
Measured: 8 weeks later
Change of serum parathyroid hormone level
Measured: 8 weeks later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionMar 2013 (estimated)
- Study completionMar 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chan Soo Shin, MD, PhD, Principal investigator, Seoul National University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01765010
- Sponsor's protocol ID
- SNUH-ENDO-2013
- Status last verified
- Jan 2013
- First submitted
- 8 Jan 2013
- Last updated
- 10 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparisons of the Effect of Inactive and Active Vitamin D on Serum Sclerostin/dickkopf1 Levels
- ClinicalTrials.gov ID
- NCT01765010
- Acronym / sponsor ID
- SNUH-ENDO-2013
- Conditions
- Osteoporosis
- Keywords
- Vitamin D, Serum sclerostin, Serum dickkopf1
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Mar 2013 (estimated)
- Study completion
- Mar 2013 (estimated)
- First posted
- 10 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the effect of inactive and active vitamin D on serum sclerostin and dickkopf1 levels.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo control | Placebo comparator | Drug: PlaceboPlacebo control |
| Cholecalciferol 1000IU | Active comparator | Drug: CholecalciferolCholecalciferol 1000IU qd for 8 weeks |
| alfacalcidol | Experimental | Drug: Alfacalcidolalfacalcidol 0.5ug qd for 8 weeks |
| Calcitriol | Experimental | Drug: CalcitriolCalcitriol 0.25ug qd for 8 weeks |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy male volunteer older than 20 years
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CalcitriolAlso: Calcio | Drug | Calcitriol |
| AlfacalcidolAlso: Onealfa | Drug | alfacalcidol |
| CholecalciferolAlso: DicamaxD | Drug | Cholecalciferol 1000IU |
| Placebo | Drug | Placebo control |
Primary outcome
Change of serum sclerostin level
Time frame: 8 weeks later
Change of serum Dickkopf1 level
Time frame: 8 weeks later
4 secondary outcomes
Change of serum c-telopeptide level
Time frame: 8 weeks later
Change of serum bone-specific alkaline phosphatase level
Time frame: 8 weeks later
Change of serum calcium level
Time frame: 8 weeks later
Change of serum parathyroid hormone level
Time frame: 8 weeks later
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chan Soo Shin, MD, PhD principal investigator
Seoul National University Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Calcitriol, Alfacalcidol and Cholecalciferol in people with Osteoporosis, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chan Soo Shin, MD, PhD (+82-2-2072-3734, csshin@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of serum sclerostin level (time frame: 8 weeks later). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2013.