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Assessment of TRACP-5b in Primary and Secondary Osteoporosis

7. november 2021 opdateret af: Amira Mohammad Abdalmageed Mansour, Assiut University

Assessment of Tartrate- Resistant Acid Posphatase 5b (TRACP-5b) in Primary and Secondary Osteoprosis

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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).

Undersøgelsestype

Observationel

Tilmelding (Forventet)

84

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

N/A

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

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.)

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Primary osteoprosis patients
patients older than 18 years with primary osteoporosis diagnosed by dxa scan . tartrate- resistant acid phosphatase 5b level will be measured.
Diagnostisk 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.
Diagnostisk 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.
Diagnostisk 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.
Diagnostisk test: Tartrate- resistant Acid Phosphatase marker
marker could be diagnostic for osteoporosis

Hvad måler undersøgelsen?

Primære resultatmål

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Assiut University

Efterforskere

  • Ledende efterforsker: AMIRA MA MANSOUR

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Forventet)

1. december 2021

Primær færdiggørelse (Forventet)

1. december 2022

Studieafslutning (Forventet)

1. maj 2023

Datoer for studieregistrering

Først indsendt

21. oktober 2021

Først indsendt, der opfyldte QC-kriterier

21. oktober 2021

Først opslået (Faktiske)

2. november 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

15. november 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

7. november 2021

Sidst verificeret

1. november 2021

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • TRACP-5b in Osteoprosis

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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