NCT03704987

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
247

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2017

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

October 10, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 15, 2018

Completed
Last Updated

October 15, 2018

Status Verified

October 1, 2018

Enrollment Period

2.6 years

First QC Date

October 10, 2018

Last Update Submit

October 11, 2018

Conditions

Osteoporosis

Keywords

KlinefelterOsteoporosisdual-energy X-ray absorptiometry

Outcome Measures

Primary Outcomes (1)

  • BMD

    bone mineral density

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

Study Arms (2)

Klinefelter

ACTIVE COMPARATOR

Male patients followed with the diagnosis of klinefelter

Diagnostic Test: dual-energy X-ray absorptiometry

Control

ACTIVE COMPARATOR

healthy male subjects

Diagnostic Test: dual-energy X-ray absorptiometry

Interventions

dual-energy X-ray absorptiometryDIAGNOSTIC_TEST

dual-energy X-ray absorptiometry

ControlKlinefelter

Eligibility Criteria

Age18 Years - 40 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsMale patiens
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • diagnosis of klinefelter

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Urology, Ercieys University, Faculty Of Medicine

Kayseri, 38039, Turkey (Türkiye)

Location

Related Publications (12)

  • 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.

    PMID: 18832949BACKGROUND

  • 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.

    PMID: 10782361BACKGROUND

  • 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.

    PMID: 20231569BACKGROUND

  • 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.

    PMID: 10093980BACKGROUND

  • 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.

    PMID: 21183376BACKGROUND

  • 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.

    PMID: 18458282BACKGROUND

  • 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.

    PMID: 20348548BACKGROUND

  • 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.

    PMID: 8167626BACKGROUND

  • 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.

    PMID: 8924228BACKGROUND

  • 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.

    PMID: 6832705BACKGROUND

  • 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.

    PMID: 8695968BACKGROUND

  • 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.

    PMID: 21126728BACKGROUND

MeSH Terms

Conditions

OsteoporosisKlinefelter Syndrome

Interventions

Absorptiometry, Photon

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesSex Chromosome Disorders of Sex DevelopmentDisorders of Sex DevelopmentUrogenital AbnormalitiesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesSex Chromosome DisordersChromosome DisordersCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGenetic Diseases, InbornGonadal DisordersEndocrine System DiseasesHypogonadism

Intervention Hierarchy (Ancestors)

RadiographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisDensitometryPhotometryChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Abdullah Demirtas, MD

    Erciyes University Faculty of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Model Details: To compare bone mineral density of klinefelter patients and normal population
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Md, Assoc. Prof.

Study Record Dates

First Submitted

October 10, 2018

First Posted

October 15, 2018

Study Start

January 1, 2015

Primary Completion

July 31, 2017

Study Completion

August 31, 2017

Last Updated

October 15, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)