An observational study in X-linked Hypophosphatemia, sponsored by Hospices Civils de Lyon. Completed at 3 sites in France. Open to participants aged 10 Years to 18 Years. Per ClinicalTrials.gov, last updated 2020-10-27.
Sponsored by Hospices Civils de Lyon · Observational
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Among 14 studies in Familial Hypophosphatemic Rickets with a site in France — 4 open to participants now, 4 under way, none of them phase 3. Familial Hypophosphatemic Rickets · France.
Among the 14 studies in Familial Hypophosphatemic Rickets with a site in France, this one is one of 3 that started in 2019, is one of 5 observational ones, and was the 5th registered.
49 studies on the registry are indexed under Familial Hypophosphatemic Rickets; 8 are open to participants now.
Browse Familial Hypophosphatemic Rickets studies →4 of the 14 studies in Familial Hypophosphatemic Rickets with a site in France are open now. Recruiting first, the newest first:
Hospices Civils de Lyon · Sites in France
Ages 10+ · Healthy volunteers
Kyowa Kirin Co., Ltd. · Sites in France, United States, Canada and 2 more countries
Ages 18–65
Kyowa Kirin Pharmaceutical Development Ltd · Sites in France, Belgium, Bulgaria and 17 more countries
University Hospital, Bordeaux · Sites in France
Ages 18+ · Healthy volunteers
A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →
Of the 4 Familial Hypophosphatemic Rickets studies recruiting now, 2 set no upper age limit and 2 stop at 75 or younger; 3 take children under 18; 1 takes healthy volunteers.
This study: 10 Years to 18 Years · all sexes.
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14 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 2 · Phase 2 3 · Phase 3 3 · Phase 4 1
First in 2014; this study’s year is marked. 3 started in 2019.
This study's enrollment of 39 is below the median of 50 across 16 observational studies indexed under Familial Hypophosphatemic Rickets.
Median enrollment 52 across the 9 interventional studies, 36 across the 5 observational. Of the 7 that completed or were terminated, 3 (43%) have results posted.
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9 of 14 have an industry lead sponsor. The 8 most frequent:
Hospices Civils de Lyon is the lead sponsor of 1,867 studies on the registry; 448 are open to participants now.
Hospices Civils de Lyon has 3 studies filed under Familial Hypophosphatemic Rickets — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 14 studies in Familial Hypophosphatemic Rickets with a site in France, from their registry updates:
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Fibroblast Growth Factor 23 and Fibroblast Growth Factor 21 are two endocrine Fibroblast Growth Factors, requiring Klotho as a co-factor to promote their systemic actions. Fibroblast Growth Factor 21 is involved in the regulation of glucid and lipid metabolism. Fibroblast Growth Factor 21 Knock Out mice display obesity and hyperglycemia.
In investigators experience, patients with X-linked hypophosphatemia often present with early-onset over-weight that could be partly explained by decreased physical activity because of bone pains and deformations after puberty; however, patients usually display progressive over-weight earlier in life, when there is no limitation of physical activity yet.
To the knowledge of investigators the association between Fibroblast Growth Factor 23, Fibroblast Growth Factor 21 and Klotho in patients with X-linked hypophosphatemia has never been evaluated. Thus, the main objective of this study is to evaluate the glucid and lipid metabolism in patients with X-linked hypophosphatemia, the main working hypothesis being that the genetic deregulation in the Fibroblast Growth Factor 23 axis in patients with X-linked hypophosphatemia induces modifications of Klotho levels (namely decreased levels) that in turn will deregulate the Fibroblast Growth Factor 21 axis (resistance to Fibroblast Growth Factor 21 because of decreased Klotho levels).
Patients aged 10 to 18 years followed in the different sites of the French Reference Center for Rare Diseases of Calcium and Phosphate, and monitored for hypophosphatemic rickets; estimated number to be included, N=40
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Exclusion Criteria:
Description of the circulating values of Fibroblast Growth Factor 21 in X-linked hypophosphatemia children compared to controls in the VITADOS cohort (healthy children and adolescents aged 10-18 years), after age-matched, pubertal stage and sex).
Circulating FGF21
Samples specific to the study will be collected during a sampling performed as part of the usual care and follow-up of the patient. An additional tube (5 ml maximum) will be collected, which will be sent to the Lyon Sud Hospital Center for analysis of circulating FGF21.
Time frame: 1 day
Plan to share: No
No publications or documents are linked to this record.
Ran from Jan 2019 to primary completion in Feb 2020, 13 months.
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This study is completed, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.
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Familial Hypophosphatemic Rickets →