ClinicalTrials.gg
Status unknownNCT03428672Updated Feb 12, 2018

Quantitative Analysis of Global Proteome in Bone Samples From Patients With Osteoporotic and Nonosteoporotic Fracture

An interventional study of total hip arthroplasty in Femoral Neck Fractures, sponsored by Second Affiliated Hospital of Soochow University. Status unknown at 1 site in China. Open to female participants aged 55 Years to 90 Years. Per ClinicalTrials.gov, last updated 2018-02-12.

Sponsored by Second Affiliated Hospital of Soochow University · Not applicable, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Feb 2018), so the status shown — last known as Not yet recruiting — may be out of date.

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Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
55 Years to 90 Years
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 22 studies in Femoral Neck Fractures with a site in China — 7 open to participants now, 7 under way, none of them phase 3. Femoral Neck Fractures · China.

Planned enrollment
12th of 20
100 · median 118
Started
2018
the only one that year
No phase
18 of 22
5 open now
Registered
7th of 22
by date
Lead sponsor
2 of 22
Second Affiliated Hospital of Soochow University

Among the 22 studies in Femoral Neck Fractures with a site in China, this one is the 12th largest by planned enrollment of the 20 interventional ones that give a count, is the only one that started in 2018, is one of 18 with no phase, and was the 7th registered.

Femoral Neck Fractures

207 studies on the registry are indexed under Femoral Neck Fractures; 40 are open to participants now.

Browse Femoral Neck Fractures studies →

Open to participants now

7 of the 22 studies in Femoral Neck Fractures with a site in China are open now. Recruiting first, the newest first:

2 more — sign in →

All 7 open studies →

A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →

Who these studies take

Of the 23 Femoral Neck Fractures studies recruiting now, 16 (70%) set no upper age limit and 4 (17%) stop at 75 or younger; 1 takes children under 18; 1 takes healthy volunteers.

This study: 55 Years to 90 Years · female · no healthy volunteers.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 22 studies in Femoral Neck Fractures with a site in China, or all of them as a file.
02

Study summary

RATIONALE: Collecting and storing bone samples from patients with osteoporotic and nonosteoporotic fracture to quantitatively analyze the differentially expressed proteins to further explain the relationship between bone iron content and bone mineral density (BMD).

PURPOSE: This research study is looking at changes of iron content and differentially expressed proteins in bone samples from patients with osteoporotic and nonosteoporotic.

fracture.

Read the detailed description

OBJECTIVES:

  1. Establish the iron content in bone specimen in patients with hip fracture.
  2. Explore the correlation of BMD and differentially expressed proteins.

OUTLINE:

  1. Collect human bone specimens from patients with osteoporotic and nonosteoporotic Fracture.
  2. Provide a repository for storage of tissue and make these specimens available for approved projects by laboratory-based investigators.
  3. Collect clinical data on these patients including bone mineral density.
  4. To examine the bone iron content using ICP/MS.
  5. Investigate the differentially expressed proteins through quantitative analysing the global proteome of osteoporotic and nonosteoporotic fracture bone specimens.
03

Conditions studied

  • Femoral Neck Fractures
04

Who can participate

Ages eligible
55 Years to 90 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Ages Eligible for Study: 55-90 Years
  2. Genders Eligible for Study: Woman
  3. Accepts Healthy Volunteers: NO
  4. Study Population: Female patients with hip fracture.

Exclusion criteria

Exclusion Criteria:

  1. or benign ovarian cysts
  2. Known chronic or systemic diseases
  3. Hormone therapy in the previous 3 months
  4. Bone metabolism and drug therapy
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    osteoporotic fractures

    patients with osteoporotic fractures, including femoral neck fracture and pertrochanteric fracture. Total hip arthroplasty or proximal femoral nails was needed.

    Procedure: total hip arthroplasty

  • Sham comparator
    nonosteoporotic fractures

    patients with nonosteoporotic fractures, including femoral neck fracture and pertrochanteric fracture. Total hip arthroplasty or proximal femoral nails was needed.

    Procedure: total hip arthroplasty

Interventions

  • Proceduretotal hip arthroplasty

    Bone samples from Hip fracture were collected from the femoral head which has been replaced

06

What researchers measure

Primary outcomes

  1. the iron content in human bone samples

    Bone samples were preprocess and decomposed by microwave.Icp-ms is used for quantitative detection of samples.

    Time frame: 3 month

Secondary outcomes

  1. The value of bone mineral density

    Bone mineral density was measured by double energy X-ray absorptiometer (DXA) in a week before surgery.

    Time frame: one week

  2. Quantitative Analysis of Global Proteome in bone samples

    Find the differentially expressed proteins in nonosteoporotic or osteoporotic bone sample through using an integrated approach involving TMT labeling and LC-MS/MS to quantify the dynamic changes of the whole proteome of Human Species.

    Time frame: 5 month

07

Study locations

1 site
  • Second Affiliated Hospital of Soochow University
    Suzhou, Jiagnsu 215004, China
08

References and documents

Publications

  • Geyer PE, Wewer Albrechtsen NJ, Tyanova S, Grassl N, Iepsen EW, Lundgren J, Madsbad S, Holst JJ, Torekov SS, Mann M. Proteomics reveals the effects of sustained weight loss on the human plasma proteome. Mol Syst Biol. 2016 Dec 22;12(12):901. doi: 10.15252/msb.20167357. PubMed 28007936 ↗
  • Roumeliotis TI, Williams SP, Goncalves E, Alsinet C, Del Castillo Velasco-Herrera M, Aben N, Ghavidel FZ, Michaut M, Schubert M, Price S, Wright JC, Yu L, Yang M, Dienstmann R, Guinney J, Beltrao P, Brazma A, Pardo M, Stegle O, Adams DJ, Wessels L, Saez-Rodriguez J, McDermott U, Choudhary JS. Genomic Determinants of Protein Abundance Variation in Colorectal Cancer Cells. Cell Rep. 2017 Aug 29;20(9):2201-2214. doi: 10.1016/j.celrep.2017.08.010. PubMed 28854368 ↗
  • Zeng Y, Zhang L, Zhu W, Xu C, He H, Zhou Y, Liu YZ, Tian Q, Zhang JG, Deng FY, Hu HG, Zhang LS, Deng HW. Corrigendum to "Quantitative proteomics and integrative network analysis identified novel genes and pathways related to osteoporosis" [J. Proteomics 142 (16 June 2016) 45-52]. J Proteomics. 2017 Jun 6;162:155. doi: 10.1016/j.jprot.2017.05.023. No abstract available. PubMed 28578906 ↗
  • Kuo HW, Kuo SM, Chou CH, Lee TC. Determination of 14 elements in Taiwanese bones. Sci Total Environ. 2000 Jun 8;255(1-3):45-54. doi: 10.1016/s0048-9697(00)00448-4. PubMed 10898394 ↗
  • Brodziak-Dopierala B, Kwapulinski J, Sobczyk K, Wiechula D. The content of manganese and iron in hip joint tissue. J Trace Elem Med Biol. 2013 Jul;27(3):208-12. doi: 10.1016/j.jtemb.2012.12.005. Epub 2013 Feb 15. PubMed 23415599 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Apr 2018; primary completion for Jan 2019, 9 months later.

Of 63 non-industry interventional studies with no phase under Femoral Neck Fractures, half reached primary completion within 44 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 62. This study's planned 9 months is below that.

Counting every sponsor, half of 69 studies reached it within 46 months; a quarter within 25 and three quarters within 68.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 31, 2018
First posted
Feb 12, 2018
StartEst.
Apr 1, 2018
Primary completionEst.
Jan 1, 2019
CompletionEst.
May 1, 2019
Last update
Feb 12, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 12, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03428672
Lead sponsor
Second Affiliated Hospital of Soochow University
Responsible party
You-Jia Xu (Director, Second Affiliated Hospital of Soochow University) — Principal investigator
First posted
Feb 12, 2018
Start date
Apr 1, 2018 (estimated)
Primary completion
Jan 1, 2019 (estimated)
Completion
May 1, 2019 (estimated)
Last update
Feb 12, 2018

Study contacts

Youjia Xu, PhD
Contact
xuyoujia@suda.edu.cn
86-0512-67783346
Fan Yang, MSc
Contact
1066276684@qq.com
86-0512-67784115
Youjia Xu, PhD
study chair · Second Affiliated Hospital of Soochow University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.

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