Clinical trial NCT03704987: Skeletal Health of Klinefelter Patients
Official title: Skeletal Health of Klinefelter Patients is Not so Bad
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoporosis
Keywords: Klinefelter
Osteoporosis
dual-energy X-ray absorptiometry
Lead sponsor: TC Erciyes University
Sponsor class: OTHER
First posted: 2018-10-15
Enrollment: 247
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: To compare bone mineral density of klinefelter patients and normal population
Primary purpose: SCREENING

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.

Eligibility criteria: 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

Primary outcomes:
measure: BMD
timeFrame: T score obtained from dual-energy X-ray absorptiometry through study completion, an average of 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Kayseri
country: Turkey
facility: Department of Urology, Ercieys University, Faculty Of Medicine
Study officials:
affiliation: Erciyes University Faculty of Medicine
name: Abdullah Demirtas, MD
role: PRINCIPAL_INVESTIGATOR
References:
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