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

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

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.

Study Overview

• Status: Completed
• Conditions: Osteoporosis
• Intervention / Treatment: 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
• Enrollment (Actual): 103

Contacts and Locations

Study Locations

• Egypt
  • Giza Egypt, Egypt, 12561
    • Radiology center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• 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

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	6 months

Collaborators and Investigators

• Sponsor: Cairo University

Publications and helpful links

General 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2018
• Primary Completion (Actual): September 30, 2018
• Study Completion (Actual): September 30, 2018

Study Registration Dates

• First Submitted: April 19, 2018
• First Submitted That Met QC Criteria: April 19, 2018
• First Posted (Actual): May 1, 2018

Study Record Updates

• Last Update Posted (Estimated): February 6, 2024
• Last Update Submitted That Met QC Criteria: February 5, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Osteoporosis
• Additional Relevant MeSH Terms: Metabolic Diseases; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Metabolic; Osteoporosis
• Other Study ID Numbers: 200070

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No