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Completed

NCT Number: NCT03513107

Osteoporosis Screening Tools' Re-validation in Egypt 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Radiology center

Giza Egypt, Egypt, 12561

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ospeoporosis score

Other
  • 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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
May 1, 2018
Registry last updated
Feb 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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