Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Norwegian Adult Achondroplasia Study

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: NCT03780153
Recruitment Status : Active, not recruiting
First Posted : December 19, 2018
Last Update Posted : September 30, 2019
Sponsor:
Information provided by (Responsible Party):
Sunnaas Rehabilitation Hospital

Tracking Information
First Submitted Date December 17, 2018
First Posted Date December 19, 2018
Last Update Posted Date September 30, 2019
Actual Study Start Date March 1, 2017
Actual Primary Completion Date March 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 11, 2019)
  • Describe the prevalence of medical complications in adults with achondroplasia [ Time Frame: 2 years ]
    Describe prevalence of medical complications in a cohort of Norwegian adults with achondroplasia using interview, clinical examination and review of medical records. Data on spinal stenosis will be obtained by face-to-face interview, clinical examination, and review of medical charts including MRI-scans. Assessment of sleep apnoea will include an overnight sleep registration (polygraphy). Hearing will be assessed by standardized examination including audiometry, tympanometry and impedance measurements
  • Describe prevalence of cardiovascular risk factors in adults with achondroplasia, and investigate body composition. [ Time Frame: 2 years ]
    Cardiovascular risk factors, including smoking habits and blood pressure, will be recorded by interview and clinical examination, and will also include a fasting blood sample for lipids, glucose, HbA1C, thyroid, kidney and liver function tests. Body composition will be assessed by anthropometric measures (height in cm, weight in kg, waist circumference in cm, and hip circumference in cm), BMI will be calculated, and body fat content and distribution will be assessed by using MRI.
  • Demographics and activity of daily living (ADL), education and work participation [ Time Frame: 2 years ]
    Data on age, gender, education level, work participation, needs for assistive devices and social benefits will be obtained by interview. Assessment of ADL will be obtained by clinical interview and by use of The Health Assessment Questionnaire
Original Primary Outcome Measures
 (submitted: December 17, 2018)
Prevalence of medical complications [ Time Frame: Fall 2019 ]
Change History Complete list of historical versions of study NCT03780153 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Norwegian Adult Achondroplasia Study
Official Title The Norwegian Adult Achondroplasia Study
Brief Summary The study aims to investigate the Norwegian adult achondroplasia population regarding degree and extent of symptoms and clinical manifestations and how this population manages in daily life, including demographics, physical function, and work participation.
Detailed Description The present study aims to investigate the degree and extent of spinal stenosis, chronic pain, sleep apnoea, impaired hearing, cardiovascular risk factors and body composition in Norwegian adults with achondroplasia. The study will also explore these factors' impact on physical function, ability to perform daily activities, work participation and needs for assistive devices and social benefits. The study is conducted in collaboration with the Norwegian Restricted Growth Association, and TRS National Resource Centre for Rare Disorders, Sunnaas Rehabilitation Hospital, Lovisenberg Hospital and Oslo University Hospital.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Diagnosis of achondroplasia will be genetically verified. Blood samples for lipids, glucose, thyroid-, liver and kidney function and key regulating hormones in fat- and glucose metabolism
Sampling Method Non-Probability Sample
Study Population Adults 16 years or older with achondroplasia
Condition Achondroplasia
Intervention Other: No intervention
Observation study. No intervention
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: December 17, 2018)
50
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 31, 2020
Actual Primary Completion Date March 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Residents of Norway
  • Aged 16 years or older
  • Clinical and genetic diagnosis of achondroplasia
  • Speak and understand the Norwegian language.

Exclusion Criteria:

  • Severe cognitive deficits, mental illness or substance abuse
  • Having a medical condition making them unable to participate in the study.
Sex/Gender
Sexes Eligible for Study: All
Gender Based Eligibility: Yes
Gender Eligibility Description: 16 years or older
Ages 16 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Norway
Removed Location Countries  
 
Administrative Information
NCT Number NCT03780153
Other Study ID Numbers 2019/FO249324
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Plan Description: Deidentified data will be available on request
Responsible Party Sunnaas Rehabilitation Hospital
Study Sponsor Sunnaas Rehabilitation Hospital
Collaborators Not Provided
Investigators
Study Director: Vegard Strom, Phd Sunnaas Rehabilitation Hospital
PRS Account Sunnaas Rehabilitation Hospital
Verification Date September 2019