NCT03513107

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
103

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 19, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 1, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2018

Completed
Last Updated

February 6, 2024

Status Verified

February 1, 2024

Enrollment Period

9 months

First QC Date

April 19, 2018

Last Update Submit

February 5, 2024

Conditions

Osteoporosis

Keywords

Osteoporosis

Outcome Measures

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).

    6 months

Interventions

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).

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

  • Adult patients undergoing dexa scan testing.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Radiology center

Giza Egypt, Egypt, 12561, Egypt

Location

Related Publications (5)

  • 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].

    BACKGROUND

  • 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.

    PMID: 12934782BACKGROUND

  • 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.

    PMID: 10813010BACKGROUND

  • 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.

    PMID: 26233285BACKGROUND

  • 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.

    BACKGROUND

MeSH Terms

Conditions

Osteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Family Medicine

Study Record Dates

First Submitted

April 19, 2018

First Posted

May 1, 2018

Study Start

January 15, 2018

Primary Completion

September 30, 2018

Study Completion

September 30, 2018

Last Updated

February 6, 2024

Record last verified: 2024-02

Locations

EG(1)