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CompletedNCT03513107Updated Feb 6, 2024

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

An observational study in Osteoporosis, sponsored by Cairo University. Completed at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-02-06.

Sponsored by Cairo University · Observational

Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
103
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Osteoporosis

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Keywords

  • Osteoporosis
03

In context

Osteoporosis

1,640 studies on the registry are indexed under Osteoporosis; 212 are open to participants now.

This study's enrollment of 103 is below the median of 174 across 446 observational studies indexed under Osteoporosis.

Browse Osteoporosis studies →

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

Inclusion criteria

  • Adult patients undergoing dexa scan testing.

Exclusion criteria

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.
05

Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
103 participants (actual)
Target follow-up
1 Day
Patient registry
Yes

Interventions

  • Otherospeoporosis 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).

06

What researchers measure

Primary outcomes

  1. Sensitivity and specificity of osteoporosis scores

    * 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).

    Time frame: 6 months

07

Study locations

1 site
  • Radiology center
    Giza Egypt, 12561, Egypt
08

References and documents

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].
  • Adler RA, Tran MT, Petkov VI. Performance of the Osteoporosis Self-assessment Screening Tool for osteoporosis in American men. Mayo Clin Proc. 2003 Jun;78(6):723-7. doi: 10.4065/78.6.723. PubMed 12934782 ↗
  • Cadarette SM, Jaglal SB, Kreiger N, McIsaac WJ, Darlington GA, Tu JV. Development and validation of the Osteoporosis Risk Assessment Instrument to facilitate selection of women for bone densitometry. CMAJ. 2000 May 2;162(9):1289-94. PubMed 10813010 ↗
  • Crandall CJ. Risk Assessment Tools for Osteoporosis Screening in Postmenopausal Women: A Systematic Review. Curr Osteoporos Rep. 2015 Oct;13(5):287-301. doi: 10.1007/s11914-015-0282-z. PubMed 26233285 ↗
  • 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.

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 6, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03513107
Lead sponsor
Cairo University
Responsible party
Saeed Salah Abduljalil Soliman (Lecturer of Family Medicine, Cairo University) — Principal investigator
First posted
May 1, 2018
Start date
Jan 15, 2018
Primary completion
Sep 30, 2018
Completion
Sep 30, 2018
Last update
Feb 6, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.

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