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CompletedNCT03704987Updated Oct 15, 2018

Skeletal Health of Klinefelter Patients

An interventional study of dual-energy X-ray absorptiometry in Osteoporosis, sponsored by TC Erciyes University. Completed at 1 site in Turkey. Open to male participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-10-15.

Sponsored by TC Erciyes University · Not applicable, Interventional, and Screening

From the registry’s dates

  • Registered 3 years 9 months after the study started (first participant enrolled Jan 2015, registered Oct 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
247
Allocation
Non-randomized
Ages
18 Years to 40 Years
Sex
Male
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Study summary

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.

Read the detailed description

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.

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Conditions studied

  • Osteoporosis

Keywords

  • Klinefelter
  • Osteoporosis
  • dual-energy X-ray absorptiometry
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In context

Osteoporosis

1,640 studies on the registry are indexed under Osteoporosis; 212 are open to participants now.

This study's enrollment of 247 is above the median of 95 across 1,133 interventional studies indexed under Osteoporosis.

Browse Osteoporosis studies →

Lead sponsor

TC Erciyes University is the lead sponsor of 341 studies on the registry; 76 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  • diagnosis of klinefelter

Exclusion criteria

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
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Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
247 participants (actual)

Study arms

  • Active comparator
    Klinefelter

    Male patients followed with the diagnosis of klinefelter

    Diagnostic Test: dual-energy X-ray absorptiometry

  • Active comparator
    Control

    healthy male subjects

    Diagnostic Test: dual-energy X-ray absorptiometry

Interventions

  • Diagnostic testdual-energy X-ray absorptiometry

    dual-energy X-ray absorptiometry

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What researchers measure

Primary outcomes

  1. BMD

    bone mineral density

    Time frame: T score obtained from dual-energy X-ray absorptiometry through study completion, an average of 2 years

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Study locations

1 site
  • Department of Urology, Ercieys University, Faculty Of Medicine
    Kayseri, 38039, Turkey
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References and documents

Publications

  • 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. PubMed 18832949 ↗
  • 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. PubMed 10782361 ↗
  • 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. PubMed 20231569 ↗
  • 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. PubMed 10093980 ↗
  • 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. PubMed 21183376 ↗
  • 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. PubMed 18458282 ↗
  • 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. PubMed 20348548 ↗
  • 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. PubMed 8167626 ↗
  • 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. PubMed 8924228 ↗
  • 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. PubMed 6832705 ↗
  • 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. PubMed 8695968 ↗
  • 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. PubMed 21126728 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 15, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03704987
Lead sponsor
TC Erciyes University
Responsible party
Abdullah Demirtas (Md, Assoc. Prof., TC Erciyes University) — Principal investigator
First posted
Oct 15, 2018
Start date
Jan 1, 2015
Primary completion
Jul 31, 2017
Completion
Aug 31, 2017
Last update
Oct 15, 2018

Study contacts

Abdullah Demirtas, MD
principal investigator · Erciyes University Faculty of Medicine

Oversight

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

Not currently enrolling

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

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