Radiological Biological Genetic and Micro-architectural Bone Determinants of Fractures in Men With Low Bone Mineral Density
NCT ID: NCT01250314
Last Updated: 2012-07-03
Study Results
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Basic Information
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COMPLETED
NA
79 participants
INTERVENTIONAL
2008-02-29
2010-12-31
Brief Summary
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Primary Objective: To search radiologic, biochemical, genetic and micro-architecture bone factors associated to fractures in men with low bone density.
Study design: case/control study (fracture vs. no fracture) with men selected according to low bone density (Z-score\<-2).
Eligibility criteria: Included subjects will be men whose age is ³ 40 and £ 70 years with a Z-score\< -2 at least at one of the 3 measured sites (wrist, lumbar spine, femoral neck). Subjects with secondary osteoporosis will be excluded (corticosteroid treatment, hypogonadism, …) Progress of the study: The recruitment will be over two years. The study will include two periods, an inclusion visit and a period of 3 months to achieve radiological and biological examinations. The subjects will be recruited in the 3 rheumatology departments (LARIBOISIERE, COCHIN). Subjects will be investigated at LARIBOISIERE hospital to perform radiological examinations and biological sampling for laboratory tests within 3 months of enrollment.
Evaluation criteria: Biochemistry: dosages of sexual steroids, bone remodeling markers and homocysteine; Genetic: evaluation of polymorphism of candidates genes associated to fragility fractures (collagen type I, homocysteine, LRP5); Radiology: evaluation of bone micro-architecture with a scan of lumbar spine and hip and peripheral micro-scan (XTREME sSCANCO) and bone densitometry at spine, femoral neck and wrist.
Duration of participation: there is no follow up Total duration of the study: 2 years and 3 months. Number of subjects: 100 patients with fracture and 100 controls without fracture
Detailed Description
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Expected results: This study will help to evaluate radiological, biochemical and genetic determinants of bone quality in men with decreased bone density. It will help to establish a prospective study to evaluate predictive factors of fractures in men.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
NONE
Study Groups
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With fracture
Patients with fracture
Radiology
Spine radiography, densitometry, evaluation of bone architecture and micro-architecture (computed tomography of lumbar spine and hip and peripheral micro-scanner (XREME SCANCO) at tibia and wrist).
Biological, biochemical and genetic samples
\*Serum calcium and phosphore evaluation, bone remodeling markers, 25-hydroxyvitamin D level assessment: Blood samples plasma (5 ml):Creatin, calcemia, phosphoremia, alkaline phosphatase, bone alkaline phosphatase, osteocalcin, CTX, 25 hydroxyvitamin D and parathormone
Urinary samples :
Deoxy-pyridinoline, creatinuria Fasting morning urine on a sample Calciuria, creatinuria, cortisoluria Day urine on a sample
\*Assessment of possible determinants of fractures in man
Blood samples plasma (5 ml):
* Sexual Hormones: Estradiol, Testosterone, SHBG, LH, FSH
* Homocysteine
* IGF1
* Extraction of DNA for a genetic polymorphism study:
Sample of 10 ml of blood on EDTA for DNA extraction.
Tested polymorphisms will be: LRP5, CYP19 (Aromatase), COL1A1 (Collagen I),MHTFR, IGF-1,VDR vitamin D receptor
Globally 20 ml of blood will be taken for each subject. Every biological sample for biochemical dosages and for genetic analysis will be preserved in an anonymous way.
Without fracture
Patients without fracture
Radiology
Spine radiography, densitometry, evaluation of bone architecture and micro-architecture (computed tomography of lumbar spine and hip and peripheral micro-scanner (XREME SCANCO) at tibia and wrist).
Biological, biochemical and genetic samples
\*Serum calcium and phosphore evaluation, bone remodeling markers, 25-hydroxyvitamin D level assessment: Blood samples plasma (5 ml):Creatin, calcemia, phosphoremia, alkaline phosphatase, bone alkaline phosphatase, osteocalcin, CTX, 25 hydroxyvitamin D and parathormone
Urinary samples :
Deoxy-pyridinoline, creatinuria Fasting morning urine on a sample Calciuria, creatinuria, cortisoluria Day urine on a sample
\*Assessment of possible determinants of fractures in man
Blood samples plasma (5 ml):
* Sexual Hormones: Estradiol, Testosterone, SHBG, LH, FSH
* Homocysteine
* IGF1
* Extraction of DNA for a genetic polymorphism study:
Sample of 10 ml of blood on EDTA for DNA extraction.
Tested polymorphisms will be: LRP5, CYP19 (Aromatase), COL1A1 (Collagen I),MHTFR, IGF-1,VDR vitamin D receptor
Globally 20 ml of blood will be taken for each subject. Every biological sample for biochemical dosages and for genetic analysis will be preserved in an anonymous way.
Interventions
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Radiology
Spine radiography, densitometry, evaluation of bone architecture and micro-architecture (computed tomography of lumbar spine and hip and peripheral micro-scanner (XREME SCANCO) at tibia and wrist).
Biological, biochemical and genetic samples
\*Serum calcium and phosphore evaluation, bone remodeling markers, 25-hydroxyvitamin D level assessment: Blood samples plasma (5 ml):Creatin, calcemia, phosphoremia, alkaline phosphatase, bone alkaline phosphatase, osteocalcin, CTX, 25 hydroxyvitamin D and parathormone
Urinary samples :
Deoxy-pyridinoline, creatinuria Fasting morning urine on a sample Calciuria, creatinuria, cortisoluria Day urine on a sample
\*Assessment of possible determinants of fractures in man
Blood samples plasma (5 ml):
* Sexual Hormones: Estradiol, Testosterone, SHBG, LH, FSH
* Homocysteine
* IGF1
* Extraction of DNA for a genetic polymorphism study:
Sample of 10 ml of blood on EDTA for DNA extraction.
Tested polymorphisms will be: LRP5, CYP19 (Aromatase), COL1A1 (Collagen I),MHTFR, IGF-1,VDR vitamin D receptor
Globally 20 ml of blood will be taken for each subject. Every biological sample for biochemical dosages and for genetic analysis will be preserved in an anonymous way.
Eligibility Criteria
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Inclusion Criteria
* Aged ≥ 40 years and ≤ 70 years
* Subject with Z-score \< -2 at least one of 3 sites
* one of 3 sites (wrists, lumbar spine (defined on at least 2 continuous evaluable vertebrae between L1-L4) and femoral neck) discovered incidentally or not
* Subject who have signed the informed consent form
The inclusion densitometry examination, less than 6 months old, will be performed on a Lunar or Hologic system. The reference data are the French reference data included in the Lunar system and TK in the Hologic system).
Exclusion Criteria
* Subject who received any corticoid treatment more than 3 months along
* Subject with any known seropositivity for HIV
* Subject with a chronic inflammation disease (rheumatoid polyarthritis, ankylosing spondylarthritis, inflammatory bowel)
* Subject with secondary osteoporosis documented by clinical and biological examinations (serum calcium, serum phosphate, serum phosphatase alkaline, gamma GT, testosterone) in order to eliminate any chronic alcoholism, alcoholic cirrhosis, hypogonadism, osteomalacia, hemochromatosis, hyperthyroidism, primitive hyperparathyroidism, hypercorticism
* Subject who received treatment with bisphosphonates intravenously
* Subject who received a treatment with bisphosphonates (Actonel® or Fosamax®) for at least 5 years and stopped since less than 2 years
* Subject who received a treatment with bisphosphonates for at least 3 years and stopped since less than 1 year
* Subject who received a treatment with bisphosphonates during the 6 months before inclusion
40 Years
70 Years
MALE
No
Sponsors
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Ministry of Health, France
OTHER_GOV
Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Principal Investigators
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Marie-Christine De VERNEJOUL, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
Locations
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Fédération de Rhumatologie - Hôpital LARIBOISIERE
Paris, , France
Countries
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Other Identifiers
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P070121
Identifier Type: -
Identifier Source: org_study_id