NL-OMON53560招募中2 期
A randomized, placebo-controlled, double blind trial to study the effects of Etidronate on ectopic CALCIfication in FAhr*s Disease or syndrome. - CALCIFADE trial
niversitair Medisch Centrum Utrecht0 个研究点目标入组 98 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 98
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Age of 18 years or over.
- •2. Clinical diagnosis of Fahr*s disease or syndrome. No international accepted
- •diagnostic criteria for Fahr*s disease or syndrome exist yet. It is diagnosed
- •mostly based on the clinical presentation. For the present study the following
- •criteria are used:
- •a. Clinical symptoms consistent with a clinical diagnosis of Fahr*s disease or
- •b. Bilateral calcifications of the basal ganglia as seen on the CT scan of the
- •head. To rule out basal ganglia calcifications due to aging, a CT based
- •calcification score will be used as proposed by Nicolas et al. Calcification is
- •graded from 0 (no calcification) to 5 (serious and confluent) in specific
- •locations of the brain; lenticular, caudate, thalamus nuclei, subcortical white
- •matter, cortex, cerebellar hemispheres, vermis, midbrain, pons, and medulla.
- •The total calcification score (ranging from 0 to 80) is obtained by adding all
- •location-specific points, where a score higher than the age-specific threshold
- •points at Fahr's disease or syndrome.
- •Furthermore, the next criteria are supportive for the clinical diagnosis of
- •Fahr's disease:
- •c. Frequently, the family history is consistent with autosomal dominant
- •inheritance. A positive family history with at least one relative in the first
- •or second degree with symptoms of Fahr*s disease is supportive for the clinical
- •diagnosis of Fahr*s disease.
- •d. The presence of a (likely) pathogenic mutation in one of the Fahr*s
- •disease-related genes is supportive for the clinical diagnosis of Fahr*s
- •disease. Mutations in up to now four known genes are associated with an
- •autosomal dominant pattern of inheritance: SLC20A2 (OMIM#213600), XPR1
- •(OMIM#616413), PDGFB (OMIM#615483), and PDGFRB (OMIM#615007). Autosomal
- •recessively inherited PFBC is associated with mutations in two genes: MYORG
- •(OMIM#618317) and JAM2 (OMIM#618824).
排除标准
- •1. Unable or unwilling to sign an informed consent.
- •2. Severe renal impairment (estimated creatinine clearance/eGFR of <30
- •ml/min/1.73m2 calculated using CKD-EPI equation).
- •3. Contraindication to receiving oral medication.
- •4. Known abnormality of the esophagus that would interfere with the passage of
- •5. Known sensitivity to etidronate.
- •6. Pregnancy, women with an active pregnancy wish <1 year, or women who are
- •breastfeeding at the time of inclusion.
- •7. Any other medical or social condition that, in the opinion of the Principal
- •Investigator, might put the subject at risk of harm during the study or might
- •adversely affect the interpretation of the study data.
- •8. Use of bisphosphonate during the last 5 years.
- •9. Hypocalcemia (calcium <2.20 mmol/L)*.
- •10. 25-OH vitamin D deficiency <35 nmol/L)*.
- •*After correcting the hypocalcemia or vitamin D deficiency, a participant is
- •again suitable for participation in the CALCIFADE trial, as long as the
- •participant meets the inclusion criteria.
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