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