NCT01246375

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2010

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 21, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 23, 2010

Completed
8 days until next milestone

Study Start

First participant enrolled

December 1, 2010

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

November 25, 2010

Status Verified

November 1, 2010

Enrollment Period

1 year

First QC Date

November 21, 2010

Last Update Submit

November 24, 2010

Conditions

Osteoporosis

Outcome Measures

Primary Outcomes (2)

  • Diagnosis of Osteoporosis

    3 month

  • Diagnosis of Osteoporosis

    3

Interventions

Dual energy X-ray absorptiometryDEVICE

Device which measures bone density

Eligibility Criteria

Age60 Years - 90 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tel Aviv medical center

Tel Aviv, Israel, Israel

Location

MeSH Terms

Conditions

Osteoporosis

Interventions

Absorptiometry, Photon

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

RadiographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisDensitometryPhotometryChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Yehuda Schwartz, M.D

    Tel Aviv Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Eitan Segal, B.Sc

CONTACT

97236947507eitansegal2@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

November 21, 2010

First Posted

November 23, 2010

Study Start

December 1, 2010

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

November 25, 2010

Record last verified: 2010-11

Locations

IL(1)