CompletedNot Applicable

Bone Fragility Study in Pediatric Population With Risk Factors

100 participantsStarted 2016-04

Plain-language 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.

Who can participate

Age range

2 Years – 21 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 .

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Bone mass

Timeframe: 1 day visit

Trial details

NCT IDNCT02751008

SponsorFundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2018-06

View on ClinicalTrials.gov More Bone Loss, Age-Related trials