Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 14 of 33 for:    klinefelter

Skeletal Health of Klinefelter Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03704987
Recruitment Status : Completed
First Posted : October 15, 2018
Last Update Posted : October 15, 2018
Sponsor:
Information provided by (Responsible Party):
Abdullah Demirtas, 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.

Condition or disease Intervention/treatment Phase
Osteoporosis Diagnostic Test: dual-energy X-ray absorptiometry Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 247 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: To compare bone mineral density of klinefelter patients and normal population
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Skeletal Health of Klinefelter Patients is Not so Bad
Actual Study Start Date : January 1, 2015
Actual Primary Completion Date : July 31, 2017
Actual Study Completion Date : August 31, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: X-Rays

Arm Intervention/treatment
Active Comparator: Klinefelter
Male patients followed with the diagnosis of klinefelter
Diagnostic Test: dual-energy X-ray absorptiometry
dual-energy X-ray absorptiometry

Active Comparator: Control
healthy male subjects
Diagnostic Test: dual-energy X-ray absorptiometry
dual-energy X-ray absorptiometry




Primary Outcome Measures :
  1. BMD [ Time Frame: T score obtained from dual-energy X-ray absorptiometry through study completion, an average of 2 years ]
    bone mineral density



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Male patiens
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03704987


Locations
Layout table for location information
Turkey
Department of Urology, Ercieys University, Faculty Of Medicine
Kayseri, Turkey, 38039
Sponsors and Collaborators
TC Erciyes University
Investigators
Layout table for investigator information
Principal Investigator: Abdullah Demirtas, MD Erciyes University Faculty of Medicine

Publications:

Layout table for additonal information
Responsible Party: Abdullah Demirtas, Md, Assoc. Prof., TC Erciyes University
ClinicalTrials.gov Identifier: NCT03704987     History of Changes
Other Study ID Numbers: 2017/33
First Posted: October 15, 2018    Key Record Dates
Last Update Posted: October 15, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Abdullah Demirtas, TC Erciyes University:
Klinefelter
Osteoporosis
dual-energy X-ray absorptiometry
Additional relevant MeSH terms:
Layout table for MeSH terms
Klinefelter Syndrome
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Sex Chromosome Disorders of Sex Development
Disorders of Sex Development
Urogenital Abnormalities
Sex Chromosome Disorders
Chromosome Disorders
Congenital Abnormalities
Genetic Diseases, Inborn
Gonadal Disorders
Endocrine System Diseases
Hypogonadism