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OsteonecrosisNCT00260897

Molecular Genetic Study of Avascular Necrosis of the Femoral Head

An observational study of Osteonecrosis, run by National Health Research Institutes, Taiwan at 1 site in Taiwan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Avascular necrosis of the femoral head (ANFH) is a debilitating disease that commonly leads to destruction of the hip joint in patients at middle age of life and often requires surgical intervention. Previously, we have identified the collagen type II, alpha 1 (COL2A1) gene as the ANFH disease gene. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Osteonecrosis
How many people
500 participants
Where
1 siteTaiwan
Study dates
May 2003to Apr 2008
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 Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • avascular necrosis of the femoral head

Who cannot join

  • -

Trial locations and contacts

1 site in 1 country.

Shih-Feng Tsai, M.D., Ph.D. contact

(886)-37-246-166 ext. 35300

petsai@nhri.org.tw

Taiwan1 site, 1 recruiting
  • Division of Molecular and Genomic Medicine, National Health Research Institutes

    Miaoli County, 350

    Shih-Feng Tsai, M.D, Ph.D, (886)-37-246-166 ext. 35300

    Recruiting

Other trials in Taiwan

About this study

Official title: Molecular Genetic Study of Avascular Necrosis of the Femoral Head-Revealing ANFH Pathogenesis Mechanism by Cell and Animal Models

Avascular necrosis of the femoral head (ANFH) is a debilitating disease that commonly leads to destruction of the hip joint in patients at middle age of life and often requires surgical intervention. Previously, we have identified the collagen type II, alpha 1 (COL2A1) gene as the ANFH disease gene. In this grant proposal, we will establish cell ine and animal models to understand the pathophysiology of ANFH, and extend our ongoing study for identifying genes responsible for non-familiar ANFH by looking into other interacting molecules of the pathway.

Read the detailed description

Avascular necrosis of the femoral head (ANFH) is a debilitating disease that usually leads to destruction of the hip joint in the third to fifth decade of life (average age, 36 years). The disease prevalence is unknown, but it has been estimated that 10,000-20,000 new cases per year are diagnosed in the United State. Nearly half of the patients eventually require hip replacement before 40 years of age. The etiology of ANFH is unknown but previous studies indicated that heritable thrombophilia (increased tendency to form thrombi) and hypofibrinolysis (reduced ability to lyse thrombi), alcohol intake, and steroid use are risk factors for ANFH.

Although the majority of idiopathic ANFH cases are sporadic, recently we identified three ANFH families showing autosomal dominant inheritance. By genome-wide scan, a significant two-point LOD score of 3.45 at = 0 was obtained between one ANFH pedigree and marker D12S85 on chromosome 12. High-resolution mapping was conducted in a second ANFH family and replicated the linkage to D12S368. When an age-dependent penetrance model was applied, the combined multipoint LOD score achieved 6.43 between D12S1663 and D12S85. Furthermore, by using haplotype analysis and gene-based mutation detection, we have identified the collagen type II, alpha 1 (COL2A1) gene, as the ANFH disease gene. Re-sequencing of the type II collagen (COL2A1) gene demonstrated a glycine with serine mutation in the G-X-Y repeat of type II collagen, in all affected individuals in three pedigrees. In the Pedigree I, a 3665G >A mutation in exon 50 of the COL2A1 gene (Genbank accession number NM_001844) and the substitution resulted in a Gly1170Ser codon change (Genbank accession number NP_001835). A second pedigree was shown to harbor the same mutation but the mutant allele existed in a different haplotype background. In a third pedigree, a 2306G>A mutation occurred in exon 33 of the gene (Genbank accession number NM_001844), causing glycine to serine change at codon 717 (Genbank accession number NP_001835).

On this basis, we propose to study the pathophysiological mechanism(s) of inherited and sporadic ANFH. The main focus of this project includes: (1) Establishing cell line and animal models to investigate the molecular basis of ANFH pathogenesis. (2) Conducting genetic analysis on sporadic ANFH cases, including those who are idiopathic, alcohol consumers or steroid-induced. (3) Using COL2A1 gene as a target, we will design novel therapeutics and prediction procedures to improve the management of the ANFH patients.

Conditions
Osteonecrosis
Keywords
avascular necrosis of the femoral head, genotyping, linkage analysis, pathogenesis, therapy
Medical subject headings
Osteonecrosis, Femur Head Necrosis

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Dec 2005 (estimated)
  2. Study startMay 2003
  3. Study completionApr 2008 (estimated)

Resources

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
Defined population
Time perspective
Other
Enrolment
500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00260897
Sponsor's protocol ID
EC 9206002
Status last verified
May 2007
First submitted
1 Dec 2005
Last updated
8 May 2007
Results posted
No

Questions about this trial

What is this clinical trial studying?

An observational study of Osteonecrosis, run by National Health Research Institutes, Taiwan at 1 site in Taiwan.

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 1 inclusion and 1 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 8 May 2007. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

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 Shih-Feng Tsai, M.D., Ph.D. ((886)-37-246-166 ext. 35300, petsai@nhri.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?
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 8 May 2007.

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