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Assessment of TRACP-5b in Primary and Secondary Osteoporosis

A

Assiut University

Status

Unknown

Conditions

Osteoporosis

Treatments

Diagnostic Test: Tartrate- resistant Acid Phosphatase marker

Study type

Observational

Funder types

Other

Identifiers

NCT05103592
TRACP-5b in Osteoprosis

Details and patient eligibility

About

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.

Full 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).

Enrollment

84 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.)

Trial design

84 participants in 4 patient groups

Primary osteoprosis patients
Description:
patients older than 18 years with primary osteoporosis diagnosed by dxa scan . tartrate- resistant acid phosphatase 5b level will be measured.
Treatment:
Diagnostic Test: Tartrate- resistant Acid Phosphatase marker
Rheumatoid arthritis patients
Description:
patients older than 18 years with primary osteoporosis diagnosed by dxa scan and rhumatoid arthritis. tartrate- resistant acid phosphatase 5b level will be measured.
Treatment:
Diagnostic Test: Tartrate- resistant Acid Phosphatase marker
Ankylosing spondylitis patients
Description:
patients older than 18 years with primary osteoporosis diagnosed by dxa scan and ankylosing spondylitis. tartrate- resistant acid phosphatase 5b level will be measured.
Treatment:
Diagnostic Test: Tartrate- resistant Acid Phosphatase marker
Control group
Description:
patients older than 18 years not complaining of any bone disease tartrate- resistant acid phosphatase 5b level will be measured.
Treatment:
Diagnostic Test: Tartrate- resistant Acid Phosphatase marker

Trial contacts and locations

0

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Central trial contact

MARWA AG ABDULAZIZ, Professor; AMIRA MA MANSOUR, Resident

Data sourced from clinicaltrials.gov

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