Back to resultsPrevalence of Osteoporosis in Patients Who Uses Inhaled Steroids
Primary Purpose
Osteoporosis
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Dual energy X-ray absorptiometry
Sponsored by
About this trial
This is an interventional diagnostic trial for Osteoporosis
Eligibility Criteria
Inclusion Criteria:
- Man at the minimum age of 60 years.
- Diagnosed with Chronic Obstructive Pulmonary disease (COPD) or Asthma disease.
- Usage of the following corticosteroids at the minimal doses indicated, for at least 3 years:
Seretide 250/50 mcg Symbicort 320/9 mcg 5.No Diagnosis of thyroid irregularity 6.No diagnosis/treatment for Osteoporosis.
Exclusion Criteria:
- Usage of systemic steroids more than once during the 12 months prior to the study.
- Usage of systemic steroids during the month prior to the study.
- Usage of inhaled steroids in order to treat any other disease except Chronic Obstructive Pulmonary Disease (COPD) or Asthma.
Sites / Locations
- Tel Aviv medical center
Outcomes
Primary Outcome Measures
Diagnosis of Osteoporosis
Diagnosis of Osteoporosis
Secondary Outcome Measures
Full Information
NCT ID
NCT01246375
First Posted
November 21, 2010
Last Updated
November 24, 2010
Sponsor
Tel-Aviv Sourasky Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01246375
Brief Title
Prevalence of Osteoporosis in Patients Who Uses Inhaled Steroids
Official Title
Prevalence of Osteoporosis in Patients Who Uses Inhaled Steroids
Study Type
Interventional
2. Study Status
Record Verification Date
November 2010
Overall Recruitment Status
Unknown status
Study Start Date
December 2010 (undefined)
Primary Completion Date
December 2011 (Anticipated)
Study Completion Date
December 2011 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Tel-Aviv Sourasky Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this research is to determine whether the prevalence of osteoporosis is greater in patients who suffer from Chronic obstructive pulmonary disease (COPD) or Asthma disease and uses inhaled steroids.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Dual energy X-ray absorptiometry
Intervention Description
Device which measures bone density
Primary Outcome Measure Information:
Title
Diagnosis of Osteoporosis
Time Frame
3 month
Title
Diagnosis of Osteoporosis
Time Frame
3
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Man at the minimum age of 60 years.
Diagnosed with Chronic Obstructive Pulmonary disease (COPD) or Asthma disease.
Usage of the following corticosteroids at the minimal doses indicated, for at least 3 years:
Seretide 250/50 mcg Symbicort 320/9 mcg 5.No Diagnosis of thyroid irregularity 6.No diagnosis/treatment for Osteoporosis.
Exclusion Criteria:
Usage of systemic steroids more than once during the 12 months prior to the study.
Usage of systemic steroids during the month prior to the study.
Usage of inhaled steroids in order to treat any other disease except Chronic Obstructive Pulmonary Disease (COPD) or Asthma.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eitan Segal, B.Sc
Phone
97236947507
Email
eitansegal2@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yehuda Schwartz, M.D
Organizational Affiliation
Tel Aviv Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tel Aviv medical center
City
Tel Aviv
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eitan segal, B.Sc
Phone
97236947507
Email
eitansegal2@gmail.com
12. IPD Sharing Statement
Learn more about this trial
Prevalence of Osteoporosis in Patients Who Uses Inhaled Steroids
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