Skeletal Health of Klinefelter Patients

NCT ID: NCT03704987

Last Updated: 2018-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

247 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-01

Study Completion Date

2017-08-31

Brief Summary

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This study compared the bone health of KS patients who were actively monitored in our clinic by dual-energy X-ray absorptiometry (DXA) with that of a control group of healthy volunteers.

Detailed Description

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Klinefelter syndrome (KS) is the most common chromosome number abnormality of men, occurring in 1/500 to 1/1000 live births . It was first described in 1942 as an endocrine disorder characterised by small, hard testicles androgen deficiency, gynaecomastia and increased follicle stimulating hormone (FSH). Osteoporosis is a progressive bone remodelling disorder in which bone loss exceeds bone formation. The resulting micro-architectural defects and bone fragility are associated with increased fracture risk and mortality. In KS, testosterone deficiency is associated with decreased bone mass and low bone mineral density (BMD) , and a positive correlation of total serum testosterone and BMD has been reported . There are some exceptions ; however, most studies have reported that KS increases the risk of osteopenia and osteoporosis compared with age-matched control groups.

Conditions

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Osteoporosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

To compare bone mineral density of klinefelter patients and normal population
Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Klinefelter

Male patients followed with the diagnosis of klinefelter

Group Type ACTIVE_COMPARATOR

dual-energy X-ray absorptiometry

Intervention Type DIAGNOSTIC_TEST

dual-energy X-ray absorptiometry

Control

healthy male subjects

Group Type ACTIVE_COMPARATOR

dual-energy X-ray absorptiometry

Intervention Type DIAGNOSTIC_TEST

dual-energy X-ray absorptiometry

Interventions

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dual-energy X-ray absorptiometry

dual-energy X-ray absorptiometry

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* diagnosis of klinefelter

Exclusion Criteria

* klinefelter subjects with a history of hip or waist surgery or trauma
* for control group with known bone disease, unknown fertility hypogonadism findings on physical examination (e.g. low testicular volume or abnormal body hair), known hypogonadism, previous androgen replacement therapy any drug therapy affecting bone metabolism
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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TC Erciyes University

OTHER

Sponsor Role lead

Responsible Party

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Abdullah Demirtas

Md, Assoc. Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Abdullah Demirtas, MD

Role: PRINCIPAL_INVESTIGATOR

Erciyes University Faculty of Medicine

Locations

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Department of Urology, Ercieys University, Faculty Of Medicine

Kayseri, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Paduch DA, Fine RG, Bolyakov A, Kiper J. New concepts in Klinefelter syndrome. Curr Opin Urol. 2008 Nov;18(6):621-7. doi: 10.1097/MOU.0b013e32831367c7.

Reference Type BACKGROUND
PMID: 18832949 (View on PubMed)

Manolagas SC. Birth and death of bone cells: basic regulatory mechanisms and implications for the pathogenesis and treatment of osteoporosis. Endocr Rev. 2000 Apr;21(2):115-37. doi: 10.1210/edrv.21.2.0395.

Reference Type BACKGROUND
PMID: 10782361 (View on PubMed)

Haentjens P, Magaziner J, Colon-Emeric CS, Vanderschueren D, Milisen K, Velkeniers B, Boonen S. Meta-analysis: excess mortality after hip fracture among older women and men. Ann Intern Med. 2010 Mar 16;152(6):380-90. doi: 10.7326/0003-4819-152-6-201003160-00008.

Reference Type BACKGROUND
PMID: 20231569 (View on PubMed)

Center JR, Nguyen TV, Schneider D, Sambrook PN, Eisman JA. Mortality after all major types of osteoporotic fracture in men and women: an observational study. Lancet. 1999 Mar 13;353(9156):878-82. doi: 10.1016/S0140-6736(98)09075-8.

Reference Type BACKGROUND
PMID: 10093980 (View on PubMed)

Maravic M, Taupin P, Landais P, Roux C. Decrease of inpatient mortality for hip fracture in France. Joint Bone Spine. 2011 Oct;78(5):506-9. doi: 10.1016/j.jbspin.2010.11.006. Epub 2010 Dec 22.

Reference Type BACKGROUND
PMID: 21183376 (View on PubMed)

Liu H, Paige NM, Goldzweig CL, Wong E, Zhou A, Suttorp MJ, Munjas B, Orwoll E, Shekelle P. Screening for osteoporosis in men: a systematic review for an American College of Physicians guideline. Ann Intern Med. 2008 May 6;148(9):685-701. doi: 10.7326/0003-4819-148-9-200805060-00009.

Reference Type BACKGROUND
PMID: 18458282 (View on PubMed)

Ferlin A, Schipilliti M, Di Mambro A, Vinanzi C, Foresta C. Osteoporosis in Klinefelter's syndrome. Mol Hum Reprod. 2010 Jun;16(6):402-10. doi: 10.1093/molehr/gaq026. Epub 2010 Mar 27.

Reference Type BACKGROUND
PMID: 20348548 (View on PubMed)

Eulry F, Bauduceau B, Lechevalier D, Magnin J, Flageat J, Gautier D. [Early spinal bone loss in Klinefelter syndrome. X-ray computed tomographic evaluation in 16 cases]. Rev Rhum Ed Fr. 1993 Apr;60(4):287-91. French.

Reference Type BACKGROUND
PMID: 8167626 (View on PubMed)

Choi HR, Lim SK, Lee MS. Site-specific effect of testosterone on bone mineral density in male hypogonadism. J Korean Med Sci. 1995 Dec;10(6):431-5. doi: 10.3346/jkms.1995.10.6.431.

Reference Type BACKGROUND
PMID: 8924228 (View on PubMed)

Foresta C, Ruzza G, Mioni R, Meneghello A, Baccichetti C. Testosterone and bone loss in Klinefelter syndrome. Horm Metab Res. 1983 Jan;15(1):56-7. doi: 10.1055/s-2007-1018630. No abstract available.

Reference Type BACKGROUND
PMID: 6832705 (View on PubMed)

Luisetto G, Mastrogiacomo I, Bonanni G, Pozzan G, Botteon S, Tizian L, Galuppo P. Bone mass and mineral metabolism in Klinefelter's syndrome. Osteoporos Int. 1995;5(6):455-61. doi: 10.1007/BF01626608.

Reference Type BACKGROUND
PMID: 8695968 (View on PubMed)

Hieronimus S, Lussiez V, Le Duff F, Ferrari P, Bstandig B, Fenichel P. Klinefelter's syndrome and bone mineral density: is osteoporosis a constant feature? Ann Endocrinol (Paris). 2011 Feb;72(1):14-8. doi: 10.1016/j.ando.2010.10.002. Epub 2010 Dec 3.

Reference Type BACKGROUND
PMID: 21126728 (View on PubMed)

Other Identifiers

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2017/33

Identifier Type: -

Identifier Source: org_study_id

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