Assessment of TRACP-5b in Primary and Secondary Osteoporosis

NCT ID: NCT05103592

Last Updated: 2021-11-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

84 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-12-01

Study Completion Date

2023-05-01

Brief Summary

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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.

Detailed Description

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Osteoporosis is a disease characterized by low bone density and a deterioration of bone microarchitecture that reduces bone strength and increases the risk of fracture. The hallmark of osteoporosis is the loss of both bone mineral and bone matrix. Although Bone mass density (BMD) is still the gold standard for the diagnosis of osteoporosis, but bone turnover markers (BTMs) can provide helpful information regarding the bone remodelling process. One of these relatively recent markers is the Tartrate-resistant acid phosphatase (TRACP). TRACP, which was first identified in human leukocytes, has 2 isoforms TRAP-5a derived from macrophages and dendritic cells and TRACP-5b secreted by osteoclasts. it is believed that TRACP-5b is a useful marker of osteoclast activity, even a marker for osteoclast number, as it is associated with osteoclast differentiation, activation and proliferation. Furthermore, it has the advantage of not being affected by renal dysfunction, nor food intake and has a weak diurnal variability. And this is why it has been used as one of the bone turnover markers in evaluating the efficacy of different anti-resorptive treatments in postmenopausal osteoporosis and in 2ry OP due to rheumatoid arthritis as well as in evaluating its specificity in identification of postmenopausal OP when compared to measurement of more expensive, relatively unavailable bone mineral density (BMD).So far, limited researches are available regarding the TRACP-5b level difference among 1ry OP (postmenopausal women) and 2ry OP (ex. RA, SpA).

Conditions

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Osteoporosis

Keywords

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primary and secondary

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Primary osteoprosis patients

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

Tartrate- resistant Acid Phosphatase marker

Intervention Type DIAGNOSTIC_TEST

marker could be diagnostic for osteoporosis

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.

Tartrate- resistant Acid Phosphatase marker

Intervention Type DIAGNOSTIC_TEST

marker could be diagnostic for osteoporosis

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.

Tartrate- resistant Acid Phosphatase marker

Intervention Type DIAGNOSTIC_TEST

marker could be diagnostic for osteoporosis

Control group

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

Tartrate- resistant Acid Phosphatase marker

Intervention Type DIAGNOSTIC_TEST

marker could be diagnostic for osteoporosis

Interventions

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Tartrate- resistant Acid Phosphatase marker

marker could be diagnostic for osteoporosis

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Amira Mohammad Abdalmageed Mansour

resident doctor at Rheumatology and Rehabilitation department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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AMIRA MA MANSOUR

Role: PRINCIPAL_INVESTIGATOR

Central Contacts

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AMIRA MA MANSOUR, Resident

Role: CONTACT

Phone: 01099777532

Email: [email protected]

MARWA AG ABDULAZIZ, Professor

Role: CONTACT

Phone: 01006783422

Email: [email protected]

References

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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.

Reference Type BACKGROUND
PMID: 30122910 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 7941614 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15605190 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34632114 (View on PubMed)

Other Identifiers

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TRACP-5b in Osteoprosis

Identifier Type: -

Identifier Source: org_study_id