Skeletal Health of Klinefelter Patients

Osteoporosis Clinical Trial

Official title:

Skeletal Health of Klinefelter Patients is Not so Bad

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03704987
• Other study ID #: 2017/33
• Status: Completed
• Phase: N/A
• Start date: January 1, 2015
• Est. completion date: August 31, 2017

Study information

• Verified date: October 2018
• Source: TC Erciyes University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 247
• Est. completion date: August 31, 2017
• Est. primary completion date: July 31, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Klinefelter Syndrome
• Osteoporosis

Intervention

Diagnostic Test:
• dual-energy X-ray absorptiometry
dual-energy X-ray absorptiometry

Locations

Country	Name	City	State
Turkey	Department of Urology, Ercieys University, Faculty Of Medicine	Kayseri

Sponsors (1)

Lead Sponsor	Collaborator
TC Erciyes University

Country where clinical trial is conducted

Turkey, 

References & Publications (12)

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

Haentjens P, Magaziner J, Colón-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. — View Citation

Hiéronimus S, Lussiez V, Le Duff F, Ferrari P, Bständig B, Fénichel 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. — View Citation

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BMD	bone mineral density	T score obtained from dual-energy X-ray absorptiometry through study completion, an average of 2 years