Assessment of TRACP-5b in Primary and Secondary Osteoporosis

NCT05103592 | Unknown

• 1 other identifier: TRACP-5b in Osteoprosis
• Study Type: observational
• Target: 84
• Locations: 0 countries
• Sites: N/A

Brief Summary

Assessment of the TRACP-5b level in 1ry OP and 2ry OP such as RA and seronegative spondylitis, that may help in surrogating the use of BMD.

Conditions

Osteoporosis

Keywords

primary and secondary

Outcome Measures

Primary Outcomes (1)

• Assessment of the TRACP-5b level in 1ry OP and 2ry OP such as RA and seronegative, that may help in surrogating the use of BMD.

  Assessing Tartrate- resistant Acid Phosphatase Marker in primary osteoporosis, rheumatoid arthritis, ankylosing spondylitis and control group that may help in substituting Dxa scan.

  Baseline

Study Arms (4)

Primary osteoprosis patients

patients older than 18 years with primary osteoporosis diagnosed by dxa scan . tartrate- resistant acid phosphatase 5b level will be measured.

Diagnostic Test: Tartrate- resistant Acid Phosphatase marker

Rheumatoid arthritis patients

patients older than 18 years with primary osteoporosis diagnosed by dxa scan and rhumatoid arthritis. tartrate- resistant acid phosphatase 5b level will be measured.

Diagnostic Test: Tartrate- resistant Acid Phosphatase marker

Ankylosing spondylitis patients

patients older than 18 years with primary osteoporosis diagnosed by dxa scan and ankylosing spondylitis. tartrate- resistant acid phosphatase 5b level will be measured.

Diagnostic Test: Tartrate- resistant Acid Phosphatase marker

Control group

patients older than 18 years not complaining of any bone disease tartrate- resistant acid phosphatase 5b level will be measured.

Diagnostic Test: Tartrate- resistant Acid Phosphatase marker

Interventions

Tartrate- resistant Acid Phosphatase marker DIAGNOSTIC_TEST

marker could be diagnostic for osteoporosis

Ankylosing spondylitis patients; Control group; Primary osteoprosis patients; Rheumatoid arthritis patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult 1ry osteoporotic, rheumatoid arthritis and seronegative spondylitis patients who consecutively attend the inpatient unit or outpatient clinic of Rheumatology, Rehabilitation and Physical Medicine Department, Assiut University Hospitals will be recruited in the study.

You may qualify if:

• Patients with 1ry OP diagnosed by DXA scan .
• Any RA and SpA patients (older than 18 years old), who fulfill the for mentioned diseases criteria with secondary osteoporosis as diagnosed by DXA scan.

You may not qualify if:

• Patients unwilling to participate in the study.
• Patients with other autoimmune diseases.
• Patients depending on Glucocorticoids with in the last 6 month.
• Patients with other causes of 2ry OP (ex. Endocrinal abnormalities, Gastrointestinal diseases, Renal diseases…..etc.)

Sponsors & Collaborators

• Assiut University: lead

Related Publications (4)

• Mederle OA, Balas M, Ioanoviciu SD, Gurban CV, Tudor A, Borza C. Correlations between bone turnover markers, serum magnesium and bone mass density in postmenopausal osteoporosis. Clin Interv Aging. 2018 Aug 3;13:1383-1389. doi: 10.2147/CIA.S170111. eCollection 2018.

  PMID: 30122910 BACKGROUND

• Assessment of fracture risk and its application to screening for postmenopausal osteoporosis. Report of a WHO Study Group. World Health Organ Tech Rep Ser. 1994;843:1-129. No abstract available.

  PMID: 7941614 BACKGROUND

• Tahtela R, Seppanen J, Laitinen K, Katajamaki A, Risteli J, Valimaki MJ. Serum tartrate-resistant acid phosphatase 5b in monitoring bisphosphonate treatment with clodronate: a comparison with urinary N-terminal telopeptide of type I collagen and serum type I procollagen amino-terminal propeptide. Osteoporos Int. 2005 Sep;16(9):1109-16. doi: 10.1007/s00198-004-1819-7. Epub 2004 Dec 17.

  PMID: 15605190 BACKGROUND

• Mochizuki T, Yano K, Ikari K, Okazaki K. Effects of romosozumab or denosumab treatment on the bone mineral density and disease activity for 6 months in patients with rheumatoid arthritis with severe osteoporosis: An open-label, randomized, pilot study. Osteoporos Sarcopenia. 2021 Sep;7(3):110-114. doi: 10.1016/j.afos.2021.08.001. Epub 2021 Aug 27.

  PMID: 34632114 BACKGROUND

MeSH Terms

Conditions

Osteoporosis; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• AMIRA MA MANSOUR

  PRINCIPAL INVESTIGATOR

Central Study Contacts

AMIRA MA MANSOUR, Resident

CONTACT

01099777532; am9322729@gmail.com

MARWA AG ABDULAZIZ, Professor

CONTACT

01006783422; Marwa.a.galal@aun.edu.eg

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: resident doctor at Rheumatology and Rehabilitation department

Study Record Dates

• First Submitted: October 21, 2021
• First Posted: November 2, 2021
• Study Start: December 1, 2021
• Primary Completion: December 1, 2022
• Study Completion: May 1, 2023
• Last Updated: November 15, 2021

Record last verified: 2021-11