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

Osteoporosis Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Osteoporosis

• NCT number: NCT03513107
• Study type: Observational [Patient Registry]
• Source: Cairo University
• Status: Completed
• Start date: January 15, 2018
• Completion date: September 30, 2018