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临床试验/NCT04007614
NCT04007614撤回不适用

Bone Health in Adolescents and Young Adults With Oral Macro-progestin Treatment : Observational Study

Assistance Publique - Hôpitaux de Paris2 个研究点 分布在 1 个国家开始时间: 2020年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
试验地点
2
主要终点
Osteocalcin

研究概览

简要总结

Many factors are known to influence the acquisition of bone capital, especially estrogens in women. Estrogens have a major role in bone growth and the acquisition of bone mass peaks during puberty. This peak of bone mass is an important determinant of the risk of osteoporotic fracture in adulthood.

It is known that estrogen deficiency increases the rate of bone remodeling and engenders an imbalance between resorption and bone formation, which can lead to osteoporosis.

Oral estroprogestin contraceptives have an anti-gonadotropic effect and suppress estrogen secretion by the ovaries.

However, studies in adolescents and young adults are rare and evidence of an effect on bone is still inconclusive, although there is increasing evidence that oral estroprogestin contraceptives in teenage girls may compromise the performance of the bone mass.

Macro progestins treatments are prescribed in France to patients with contraindications to estroprogestin treatments. This practice is french and few recommendations exist on the use of these molecules by the oral route. There are no studies that describe the impact of these oral treatments on the bone health of young women treated.

The Department of endocrinology, gynecology and pediatric diabetes of Necker-Enfants Malades hospital, follows many young girls taking a macro progestin treatment. This study is exclusively descriptive and will focus on the clinical and medical datas available on the bone health of these patients.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
16 Years 至 25 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • Patients aged 16 to 25 years old
  • Patients followed at Necker-Enfants Malades hospital
  • Patients who have taken or taking macro-progestins treatment by oral route (Luteran, Lutenyl, Surgestone) for at least 6 months between the age of 16 and 25 years

排除标准

  • Patients with a pathology or treatment that can alter bone mineral density

研究组 & 干预措施

Patients

Patients who have taken a macro progestin treatment for more than 6 months between 16 and 25 years of age.

干预措施: Questionnaire (Other)

结局指标

主要结局

Osteocalcin

时间窗: Day 0

Blood test

25 OH vitamin D3

时间窗: Day 0

Blood test

Ionized calcium

时间窗: Day 0

Blood test

C-terminal telopeptide of type I collagen

时间窗: Day 0

Blood test

Natriuresis

时间窗: Day 0

Urine test

Calcemia

时间窗: Day 0

Blood test

Parathormone

时间窗: Day 0

Blood test

Bone densitometry

时间窗: Day 0

Z score values compared to the reference values

Phosphor

时间窗: Day 0

Blood test

Albumin

时间窗: Day 0

Blood test

Magnesium

时间窗: Day 0

Blood test

Creatinine

时间窗: Day 0

Blood test

Bone alkaline phosphatase isoenzymes

时间窗: Day 0

Blood test

Creatinuria

时间窗: Day 0

Urine test

Calciuria

时间窗: Day 0

Urine test

次要结局

  • Follicle stimulating hormone(Day 0)
  • Gonadotrophin b LH(Day 0)
  • Clinical tolerance of treatment(Day 0)
  • Estradiol(Day 0)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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