OsteoporosisNCT05103592
Assessment of TRACP-5b in Primary and Secondary Osteoporosis
An observational study of Osteoporosis, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoporosis
- What is being tested?
- Tartrate- resistant Acid Phosphatase marker
- How many people
- 84 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2021to 1 May 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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).
- Conditions
- Osteoporosis
- Being tested
- Tartrate- resistant Acid Phosphatase marker
- Keywords
- primary and secondary
- Medical subject headings
- Osteoporosis, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tartrate- resistant Acid Phosphatase markerDiagnostic test
marker could be diagnostic for osteoporosis
| Study group | Role | What they receive |
|---|---|---|
| Primary osteoprosis patients | patients older than 18 years with primary osteoporosis diagnosed by dxa scan . tartrate- resistant acid phosphatase 5b level will be measured. Receives: 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. Receives: 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. Receives: 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. Receives: Diagnostic Test: Tartrate- resistant Acid Phosphatase marker |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2021
- Study start1 Dec 2021 (estimated)
- Primary completion1 Dec 2022 (estimated)
- Study completion1 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amira Mohammad Abdalmageed Mansour, Assiut University
- Investigators
- AMIRA MA MANSOUR, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05103592
- Sponsor's protocol ID
- TRACP-5b in Osteoprosis
- Status last verified
- Nov 2021
- First submitted
- 21 Oct 2021
- Last updated
- 15 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 30122910Assessment 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.
PubMed 7941614Tahtela 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.
PubMed 15605190Mochizuki 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.
PubMed 34632114
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Tartrate- Resistant Acid Posphatase 5b (TRACP-5b) in Primary and Secondary Osteoprosis
- ClinicalTrials.gov ID
- NCT05103592
- Acronym / sponsor ID
- TRACP-5b in Osteoprosis
- Conditions
- Osteoporosis
- Keywords
- primary and secondary
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2021 (estimated)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 May 2023 (estimated)
- First posted
- 2 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Primary osteoprosis patients | – | Diagnostic Test: Tartrate- resistant Acid Phosphatase markerpatients older than 18 years with primary osteoporosis diagnosed by dxa scan . tartrate- resistant acid phosphatase 5b level will be measured. |
| Rheumatoid arthritis patients | – | Diagnostic Test: Tartrate- resistant Acid Phosphatase markerpatients older than 18 years with primary osteoporosis diagnosed by dxa scan and rhumatoid arthritis. tartrate- resistant acid phosphatase 5b level will be measured. |
| Ankylosing spondylitis patients | – | Diagnostic Test: Tartrate- resistant Acid Phosphatase markerpatients older than 18 years with primary osteoporosis diagnosed by dxa scan and ankylosing spondylitis. tartrate- resistant acid phosphatase 5b level will be measured. |
| Control group | – | Diagnostic Test: Tartrate- resistant Acid Phosphatase markerpatients older than 18 years not complaining of any bone disease tartrate- resistant acid phosphatase 5b level will be measured. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tartrate- resistant Acid Phosphatase markermarker could be diagnostic for osteoporosis | Diagnostic test | Ankylosing spondylitis patients, Control group, Primary osteoprosis patients, Rheumatoid arthritis patients |
Primary outcome
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.
Time frame: Baseline
Assessing Tartrate- resistant Acid Phosphatase Marker in primary osteoporosis, rheumatoid arthritis, ankylosing spondylitis and control group that may help in substituting Dxa scan.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2021.
- Background: PubMed 30122910Mederle 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.
- Background: PubMed 7941614Assessment 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.
- Background: PubMed 15605190Tahtela 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.
- Background: PubMed 34632114Mochizuki 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
AMIRA MA MANSOUR principal investigator
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoporosis, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact AMIRA MA MANSOUR, Resident (01099777532, am9322729@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05103592, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2021.