Study of longitudinal observation for patient with X-linked hypophosphatemic rickets/osteomalacia in collaboration with Asian partners

UMIN ID: UMIN000031605

Registered date:20/04/2018

Basic Information

• Recruitment status: Complete: follow-up continuing
• Health condition(s) or Problem(s) studied: X-linked hypophosphatemic rickets/osteomalacia
• Date of first enrollment: 2018/05/01
• Target sample size: 240
• Countries of recruitment: Japan,Asia(except Japan)
• Study type: Observational

Outcome(s)

• Primary Outcome: Patients aged,<18years:Height,Rickets Severity Score,QOL,and motor function Patients aged >=18years:QOL and motor function
• Secondary Outcome: Patients aged <18 years:Growth velocity, lower limb deformity,biomarkers for phosphorus metabolism and bone metabolism,and fracture Patients aged >=18 years:Biomarkers for phosphorus metabolism and bone metabolism,fracture,spinal ligament ossification,nephrocalcinosis,and renal function

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1. Participation in any clinical study (trial) sponsored by Kyowa Kirin at the time of informed consent 2. Any patient whose participation in the study is considered inappropriate by the investigator or the subinvestigator

Related Information

• Primary Sponsor: Kyowa Kirin Co., Ltd.
• Source(s) of Monetary Support: Kyowa Kirin Co., Ltd.