Endocrine System DiseasesOMSOSTNCT01553344
Serum Sclerostin Level & Treatment of Vitamin D Deficiency
An observational study of Endocrine System Diseases and Vitamin D Deficiency, run by Bagcilar Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to determine serum sclerostin levels and change in serum sclerostin levels in patients with Vitamin D deficiency treated with calcium and vitamin D. Healthy premenopausal Patients with Vitamin D deficiency diagnosed and routinely treated with calcium and vitamin D will be included in the… Read more about this study
- Who is it for?
- Ages 20 to 50 years, women only
- Conditions the study is for
- Endocrine System Diseases, Vitamin D Deficiency
- How many people
- 26 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Mar 2012to Nov 2013
- Phase
- Observational
- 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 50 years
- Women only
- No healthy volunteers
- Adult
Study population: Patients with vitamin D deficiency
Who may be able to join
- Premenopausal
- Serum 25(OH)D < 10 ng/mL
Who cannot join
- Anemia
- Tumor-induced osteomalacia (hypophosphatemia)
- Hypothyroidism
- Hepatic / renal disease
- Primary hyperparathyroidism
- Fibromyalgia
Show all 9Show fewer
- Polymyalgia rheumatica
- Serum 25(OH)D > 10 ng/mL
- Vitamin D and calcium treatment commenced prior to study participation
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bagcilar Training & Research Hospital
Istanbul
About this study
Official title: Serum Sclerostin Level in Patients With Vitamin D Deficiency
The aim of this study is to determine serum sclerostin levels and change in serum sclerostin levels in patients with Vitamin D deficiency treated with calcium and vitamin D.
Healthy premenopausal Patients with Vitamin D deficiency diagnosed and routinely treated with calcium and vitamin D will be included in the study. This is an observational study. The serum sclerostin levels will be measured before and after Vitamin D treatment.
Read the detailed description
This study is a prospective, observational, single-center study. Ethical approval was obtained from the Institutional Review Board.
This study will be completed with patients with Vitamin D deficiency. An intravenous cannula will be inserted into the antecubital vein. Blood samples will be obtained before and after treatment.
Serum will be collected and will be centrifuged for 15 minutes at 1000Xg within 30 minutes of collection. Aliquots of serum will be added to eppendorf tubes and stored at -20°C.
Serum sclerostin levels will be measured using a Human Sclerostin ELISA kit (Cusabio, Catalog No: CSB-E13146h, Newark, DE, USA). All assays will be performed according to the manufacturer's instructions. The minimum detectable concentration of human sclerostin is typically <0.012 ng/ml. Intra-assay precision is less than 8%.
- Conditions
- Endocrine System Diseases, Vitamin D Deficiency
- Keywords
- sclerostin, osteomalacia, vitamin D deficiency
- Medical subject headings
- Endocrine System Diseases, Vitamin D Deficiency, Sclerosteosis, Osteomalacia
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum sclerostin level
Changes in serum sclerostin level in patients with osteomalacia who are scheduled for routine treatment of osteomalacia
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionApr 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endocrine System DiseasesStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bagcilar Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ilhan Karacan, Clinical Associated Professor, Bagcilar Training and Research Hospital
- Investigators
- MUHARREM CIDEM, MD, Principal investigator, Bagcilar Training & Research Hospital Istanbul, Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01553344
- Sponsor's protocol ID
- BEAH FTR -7
- Acronym
- OMSOST
- Status last verified
- Dec 2014
- First submitted
- 12 Mar 2012
- Last updated
- 23 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum Sclerostin Level in Patients With Vitamin D Deficiency
- ClinicalTrials.gov ID
- NCT01553344
- Acronym / sponsor ID
- OMSOST / BEAH FTR -7
- Conditions
- Endocrine System Diseases, Vitamin D Deficiency
- Keywords
- sclerostin, osteomalacia, vitamin D deficiency
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Bagcilar Training and Research HospitalOther government
- Study start
- Mar 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 14 Mar 2012 (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 aim of this study is to determine serum sclerostin levels and change in serum sclerostin levels in patients with Vitamin D deficiency treated with calcium and vitamin D.
Healthy premenopausal Patients with Vitamin D deficiency diagnosed and routinely treated with calcium and vitamin D will be included in the study. This is an observational study. The serum sclerostin levels will be measured before and after Vitamin D treatment.
Detailed description
This study is a prospective, observational, single-center study. Ethical approval was obtained from the Institutional Review Board.
This study will be completed with patients with Vitamin D deficiency. An intravenous cannula will be inserted into the antecubital vein. Blood samples will be obtained before and after treatment.
Serum will be collected and will be centrifuged for 15 minutes at 1000Xg within 30 minutes of collection. Aliquots of serum will be added to eppendorf tubes and stored at -20°C.
Serum sclerostin levels will be measured using a Human Sclerostin ELISA kit (Cusabio, Catalog No: CSB-E13146h, Newark, DE, USA). All assays will be performed according to the manufacturer's instructions. The minimum detectable concentration of human sclerostin is typically <0.012 ng/ml. Intra-assay precision is less than 8%.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients with vitamin D deficiency
Key inclusion criteria (2 listed)
- Premenopausal
- Serum 25(OH)D < 10 ng/mL
Key exclusion criteria (9 listed)
- Anemia
- Tumor-induced osteomalacia (hypophosphatemia)
- Hypothyroidism
- Hepatic / renal disease
- Primary hyperparathyroidism
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Serum sclerostin level
Time frame: 8 weeks
Changes in serum sclerostin level in patients with osteomalacia who are scheduled for routine treatment of osteomalacia
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2014.
Related trials for Endocrine System Diseases
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
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.
MUHARREM CIDEM, MD principal investigator
Bagcilar Training & Research Hospital Istanbul, Turkey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endocrine System Diseases and Vitamin D Deficiency, run by Bagcilar Training and Research Hospital at 1 site in Turkey (Türkiye).
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 2 inclusion and 9 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: finished, as of the sponsor's last update on 23 Dec 2014. 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 Turkey (Türkiye). 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum sclerostin level (time frame: 8 weeks). 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 23 Dec 2014.