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Bone Fragility Study in Pediatric Population With Risk Factors

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ClinicalTrials.gov Identifier: NCT02751008
Recruitment Status : Completed
First Posted : April 26, 2016
Last Update Posted : November 14, 2018
Sponsor:
Information provided by (Responsible Party):
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Brief Summary:
Low bone mass and osteoporosis are underdiagnosed in childhood in our environment and its prevalence is unknown. In most cases they are secondary to chronic diseases that conduct to a poor bone health condition and thereby a risk of fracture increased. The aim of this study is to identify patients with risk factors for low bone mass and determine their Bone Mineral Density (amount of bone) by performing bone densitometry and compared with healthy population of the same characteristics. Also the investigators want to evaluate bone quality by application of Trabecular Bone Score to images obtained by densitometry. As secondary objectives the investigators intend to correlate the data with with clinical variables to identify the most important in bone health clinical factors. In addition to measuring bone quality and quantity demographic and clinical process related to bone quality base and variables will be collected.

Condition or disease
Bone Loss, Age-Related

  Show Detailed Description

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Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: Bone Fragility Study in Pediatric Population With Risk Factors
Actual Study Start Date : April 2016
Actual Primary Completion Date : June 2018
Actual Study Completion Date : June 2018



Primary Outcome Measures :
  1. Bone mass [ Time Frame: 1 day visit ]

Secondary Outcome Measures :
  1. Bone quality [ Time Frame: 1 day visit ]
    Performing Trabecular Bone Score vapplied directly to the information obtained through the spinal DXA



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Ages Eligible for Study:   2 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients under 21 years of age who are at risk of bone fragility (pediatric patients with primary bone diseases or potential secondary bone diseases (eg , chronic inflammatory diseases , endocrine disorders , history of cancer or pre- transplant) and whose parents / guardians have signed the informed consent
Criteria

Inclusion Criteria:

  • Patients under 21 years of age who are at risk of bone fragility ( according to criteria previously set forth in the background section ) and whose parents / guardians have signed the informed consent

Exclusion Criteria:

  • Subjects who refuse to participate in the study. Over 16 years old. Bone prior active treatment .

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Responsible Party: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
ClinicalTrials.gov Identifier: NCT02751008     History of Changes
Other Study ID Numbers: IIBSP-FRA-2016-11
First Posted: April 26, 2016    Key Record Dates
Last Update Posted: November 14, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
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Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases