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Osteoporosis Screening Tools' Re-validation in Egypt Guide for the Management of the Condition in Males

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ClinicalTrials.gov Identifier: NCT03513107
Recruitment Status : Recruiting
First Posted : May 1, 2018
Last Update Posted : May 1, 2018
Sponsor:
Information provided by (Responsible Party):
Saeed Salah Abduljalil Soliman, Cairo University

Brief Summary:
To demonstrate the predictive ability of the different screening scores (i.e. OST, ORAI, ABONE, body weight criterion, age alone or others) and their potential use in the primary care setting.

Condition or disease Intervention/treatment
Osteoporosis Other: ospeoporosis score

Detailed Description:
  • A primary care sample of records at a local radiology center will be retrospectively reviewed and those of Egyptian adults who underwent DXA scanning will be included.
  • Those with prior diagnoses that can affect bone mineral density (BMD) (i.e. prior osteoporosis, Paget's disease, osteomalacia, hyperparathyroidism, or hypogonadism) or history of using certain medications (i.e. bone-protective or anticonvulsant drugs) prior to undergoing the DXA scan will be excluded.
  • Scores will be calculated as indicated in their respective studies after collecting the data pertaining to them (Crandall, 2015); (Cass & Shepherd, 2013); (Reginster, et al., 2004); (Adler, et al., 2003); (Cadarette, et al., 2000); (Weinstein & Ulery, 2000); (Black, et al., 1998); (Lydick, et al., 1998).
  • Data will be treated as dichotomous for both DXA T-scores and screening scores (i.e. Osteoporosis (Yes or NO) versus positive/negative score). A 2 x 2 contingency table will be constructed and the different diagnostic test statistics (i.e. Sensitivities, specificities, Receiver operating characteristic curve) will be calculated using different Cut-off points to carry out sensitivity analyses (Moreover, different DXA sites and cut-offs will be included in the analyses). SPSS version 25 software (IBM Corp., USA) will be used for the statistical operations.
  • Using an expected proportion of false negatives of 10% for sensitivity (i.e. based on the previous reported sensitivities for most tools being >90% (Crandall, 2015) and the performance of OST in Egypt of 83% (El-Masry, et al., 2015)) and a 95% confidence interval's width of 10% the needed sample size was estimated to be 138 (Browner, et al., 2013, p. 81 Table 6E). Power analysis will be calculated for any deviation from this estimation. Failure to meet sample size at the outset will be dealt with by prospectively screening new records for a period of 3 months.

Depending on the result, further recommendations and plans will be provided for possible applications and future research. All Deviations from the protocol will be justified.


Study Type : Observational [Patient Registry]
Estimated Enrollment : 140 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 1 Day
Official Title: Osteoporosis in Egypt: Screening Tools' Re-validation and a Local Guide for the Management of the Condition in Males
Actual Study Start Date : January 15, 2018
Estimated Primary Completion Date : July 30, 2018
Estimated Study Completion Date : September 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoporosis


Intervention Details:
  • Other: ospeoporosis score
    • Scores will be calculated as indicated in their respective studies after collecting the data pertaining to them (Crandall, 2015); (Cass & Shepherd, 2013); (Reginster, et al., 2004); (Adler, et al., 2003); (Cadarette, et al., 2000); (Weinstein & Ulery, 2000); (Black, et al., 1998); (Lydick, et al., 1998).
    • Data will be treated as dichotomous for both DXA T-scores and screening scores (i.e. Osteoporosis (Yes or NO) versus positive/negative score).


Primary Outcome Measures :
  1. Sensitivity and specificity of osteoporosis scores [ Time Frame: 6 months ]
    • Scores will be calculated as indicated in their respective studies after collecting the data pertaining to them (Crandall, 2015); (Cass & Shepherd, 2013); (Reginster, et al., 2004); (Adler, et al., 2003); (Cadarette, et al., 2000); (Weinstein & Ulery, 2000); (Black, et al., 1998); (Lydick, et al., 1998).
    • Data will be treated as dichotomous for both DXA T-scores and screening scores (i.e. Osteoporosis (Yes or NO) versus positive/negative score).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
- A primary care sample of records at a local radiology center will be retrospectively reviewed and those of Egyptian adults who underwent DXA scanning will be included
Criteria

Inclusion Criteria:

  • Adult patients undergoing dexa scan testing.

Exclusion Criteria:

  • people with prior diagnoses that can affect bone mineral density (BMD) (i.e. prior osteoporosis, Paget's disease, osteomalacia, hyperparathyroidism, or hypogonadism) or history of using certain medications (i.e. bone-protective or anticonvulsant drugs) prior to undergoing the DXA scan.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03513107


Locations
Egypt
Radiology center Recruiting
Giza Egypt, Egypt, 12561
Contact: Saeed Soliman    1020007027    drsaeedsalah@gmail.com   
Principal Investigator: Ahmed Mettawi         
Sponsors and Collaborators
Cairo University

Publications:
dib, M. G., Nauroy, L. & Fuleihan, G. E., 2011. THE MIDDLE EAST & AFRICA REGIONAL AUDIT: Epidemiology, costs & burden of osteoporosis in 2011. [Online] Available at: https://www.iofbonehealth.org/sites/default/files/PDFs/Audit%20Middle%20East_Africa/Middle_East_Africa_audit.pdf [Accessed 31 /01 /2018].
El-Masry, S. A., Hassan, N. E. & El-Banna, R. A., 2015. A new predictive index for osteoporosis among a sample of postmenopausal Egyptian women. Research Journal of Pharmaceutical, Biological and Chemical Sciences, 6(1), pp. 975-981.

Responsible Party: Saeed Salah Abduljalil Soliman, Lecturer of Family Medicine, Cairo University
ClinicalTrials.gov Identifier: NCT03513107     History of Changes
Other Study ID Numbers: 200070
First Posted: May 1, 2018    Key Record Dates
Last Update Posted: May 1, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Saeed Salah Abduljalil Soliman, Cairo University:
Osteoporosis

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases