Assessment of TRACP-5b in Primary and Secondary Osteoporosis

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05103592
Collaborator
(none)
84
17

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Tartrate- resistant Acid Phosphatase marker

Detailed Description

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).

Study Design

Study Type:
Observational
Anticipated Enrollment :
84 participants
Observational Model:
Case-Control
Time Perspective:
Retrospective
Official Title:
Assessment of Tartrate- Resistant Acid Posphatase 5b (TRACP-5b) in Primary and Secondary Osteoprosis
Anticipated Study Start Date :
Dec 1, 2021
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
May 1, 2023

Arms and Interventions

Arm Intervention/Treatment
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
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.

Diagnostic Test: Tartrate- resistant Acid Phosphatase marker
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.

Diagnostic Test: Tartrate- resistant Acid Phosphatase marker
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.

Diagnostic Test: Tartrate- resistant Acid Phosphatase marker
marker could be diagnostic for osteoporosis

Outcome Measures

Primary Outcome Measures

  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. [Baseline]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
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.)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Assiut University

Investigators

  • Principal Investigator: AMIRA MA MANSOUR,

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Amira Mohammad Abdalmageed Mansour, resident doctor at Rheumatology and Rehabilitation department, Assiut University
ClinicalTrials.gov Identifier:
NCT05103592
Other Study ID Numbers:
  • TRACP-5b in Osteoprosis
First Posted:
Nov 2, 2021
Last Update Posted:
Nov 15, 2021
Last Verified:
Nov 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Amira Mohammad Abdalmageed Mansour, resident doctor at Rheumatology and Rehabilitation department, Assiut University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 15, 2021