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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT04007614
Other study ID # APHP190093
Secondary ID IDRCB : 2019-A00
Status Withdrawn
Phase
First received
Last updated
Start date April 2020
Est. completion date February 2021

Study information

Verified date November 2022
Source Assistance Publique - Hôpitaux de Paris
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date February 2021
Est. primary completion date February 2021
Accepts healthy volunteers No
Gender Female
Age group 16 Years to 25 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Questionnaire
Fardellone questionnaire (evaluation of calcium intake) Tolerance of treatment

Locations

Country Name City State
France Hôpital Necker-Enfants Malades Paris

Sponsors (1)

Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Bone densitometry Z score values compared to the reference values Day 0
Primary Calcemia Blood test Day 0
Primary Ionized calcium Blood test Day 0
Primary Phosphor Blood test Day 0
Primary Magnesium Blood test Day 0
Primary Albumin Blood test Day 0
Primary Parathormone Blood test Day 0
Primary 25 OH vitamin D3 Blood test Day 0
Primary Creatinine Blood test Day 0
Primary Osteocalcin Blood test Day 0
Primary Bone alkaline phosphatase isoenzymes Blood test Day 0
Primary C-terminal telopeptide of type I collagen Blood test Day 0
Primary Calciuria Urine test Day 0
Primary Natriuresis Urine test Day 0
Primary Creatinuria Urine test Day 0
Secondary Clinical tolerance of treatment 6 questions asked to the patient under treatment, a yes or no answer is expected : presence of menstruating, regularity of cycles, out-of-periods bleeding, weight gain, acne, satisfaction in relation to treatment. Day 0
Secondary Follicle stimulating hormone Blood test, patients under macro progestin treatment at day 0 Day 0
Secondary Gonadotrophin b LH Blood test, patients under macro progestin treatment at day 0 Day 0
Secondary Estradiol Blood test, patients under macro progestin treatment at day 0 Day 0
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