Skeletal Health of Klinefelter Patients

T

TC Erciyes University

Status

Completed

Conditions

Osteoporosis

Treatments

Diagnostic Test: dual-energy X-ray absorptiometry

Study type

Interventional

Funder types

Other

Identifiers

NCT03704987
2017/33

Details and patient eligibility

About

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.

Full 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.

Enrollment

247 patients

Sex

Male

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Screening

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

247 participants in 2 patient groups

Klinefelter
Active Comparator group
Description:
Male patients followed with the diagnosis of klinefelter
Treatment:
Diagnostic Test: dual-energy X-ray absorptiometry
Control
Active Comparator group
Description:
healthy male subjects
Treatment:
Diagnostic Test: dual-energy X-ray absorptiometry

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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