Skeletal Health of Klinefelter Patients

Not Applicable

Completed

• Conditions: Osteoporosis
• Interventions: Diagnostic Test: dual-energy X-ray absorptiometry

• Registration Number: NCT03704987
• Lead Sponsor: TC Erciyes University

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.

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.

Study Timeline

• Study Start: 2015-01-01
• Primary Completion: 2017-07-31
• Study Completion: 2017-08-31
• Status Verified: 2018-10
• Study First Submitted: 2018-10-10
• Study First Submitted QC: 2018-10-11
• Last Update Submitted: 2018-10-11
• Study First Posted: 2018-10-15
• Last Update Posted: 2018-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 247

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Klinefelter	dual-energy X-ray absorptiometry	Male patients followed with the diagnosis of klinefelter
Control	dual-energy X-ray absorptiometry	healthy male subjects

Primary Outcome Measures

Name	Time	Method
BMD	T score obtained from dual-energy X-ray absorptiometry through study completion, an average of 2 years	bone mineral density

Trial Locations

Locations (1)

Department of Urology, Ercieys University, Faculty Of Medicine; 🇹🇷 Kayseri, Turkey