Clinical trial NCT04007614: Bone Health in Adolescents and Young Adults With Oral Macro-progestin Treatment
Official title: Bone Health in Adolescents and Young Adults With Oral Macro-progestin Treatment : Observational Study
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Contraception
Macro-progestins
Keywords: Macro-progestins
Bone health
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2019-07-05
Enrollment: 0
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients followed by the department of endocrinology, gynecology and pediatric diabetes of Necker hospital.

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: Bone densitometry
timeFrame: Day 0
measure: Calcemia
timeFrame: Day 0
measure: Ionized calcium
timeFrame: Day 0
measure: Phosphor
timeFrame: Day 0
measure: Magnesium
timeFrame: Day 0
measure: Albumin
timeFrame: Day 0
measure: Parathormone
timeFrame: Day 0
measure: 25 OH vitamin D3
timeFrame: Day 0
measure: Creatinine
timeFrame: Day 0
measure: Osteocalcin
timeFrame: Day 0
measure: Bone alkaline phosphatase isoenzymes
timeFrame: Day 0
measure: C-terminal telopeptide of type I collagen
timeFrame: Day 0
measure: Calciuria
timeFrame: Day 0
measure: Natriuresis
timeFrame: Day 0
measure: Creatinuria
timeFrame: Day 0
Secondary outcomes:
measure: Clinical tolerance of treatment
timeFrame: Day 0
measure: Follicle stimulating hormone
timeFrame: Day 0
measure: Gonadotrophin b LH
timeFrame: Day 0
measure: Estradiol
timeFrame: Day 0
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Necker-Enfants Malades
Study officials:
affiliation: Hôpital Necker-Enfants Malades
name: Sabrina Da Costa, MD
role: STUDY_DIRECTOR
References: