OsteoporosisNCT03513107
Osteoporosis Screening Tools' Re-validation in Egypt Guide for the Management of the Condition in Males
An observational study of Osteoporosis, run by Cairo University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoporosis
- What is being tested?
- ospeoporosis score
- How many people
- 103 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jan 2018to 30 Sep 2018
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- Adult patients undergoing dexa scan testing.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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.
- Conditions
- Osteoporosis
- Being tested
- ospeoporosis score
- Keywords
- Osteoporosis
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ospeoporosis scoreOther
- 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).
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2018
- Study start15 Jan 2018
- Primary completion30 Sep 2018
- Study completion30 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 103 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Saeed Salah Abduljalil Soliman, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03513107
- Sponsor's protocol ID
- 200070
- Status last verified
- Feb 2024
- First submitted
- 19 Apr 2018
- Last updated
- 6 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 12934782Cadarette 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 10813010Crandall 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 26233285El-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 at a glance
From the registry record, last updated by the sponsor on 6 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Osteoporosis in Egypt: Screening Tools' Re-validation and a Local Guide for the Management of the Condition in Males
- ClinicalTrials.gov ID
- NCT03513107
- Acronym / sponsor ID
- 200070
- Conditions
- Osteoporosis
- Keywords
- Osteoporosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Jan 2018 (actual)
- Primary completion
- 30 Sep 2018 (actual)
- Study completion
- 30 Sep 2018 (actual)
- First posted
- 1 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- Adult patients undergoing dexa scan testing.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Other | – |
Primary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2024.
- Backgrounddib, 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].
- Background: PubMed 12934782Adler 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.
- Background: PubMed 10813010Cadarette 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.
- Background: PubMed 26233285Crandall 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.
- BackgroundEl-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 dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoporosis, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and specificity of osteoporosis scores (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03513107, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2024.