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

Withdrawn

• Conditions: Contraception; Macro-progestins
• Interventions: Other: Questionnaire

• Registration Number: NCT04007614
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-04-17
• Study First Submitted QC: 2019-07-02
• Study First Posted: 2019-07-05
• Study Start: 2020-04
• Primary Completion: 2021-02
• Study Completion: 2021-02
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-07
• Last Update Posted: 2022-11-08

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Osteocalcin	Day 0	Blood test
Ionized calcium	Day 0	Blood test
C-terminal telopeptide of type I collagen	Day 0	Blood test
Natriuresis	Day 0	Urine test
Calcemia	Day 0	Blood test
Parathormone	Day 0	Blood test
Bone densitometry	Day 0	Z score values compared to the reference values
Phosphor	Day 0	Blood test
Albumin	Day 0	Blood test
25 OH vitamin D3	Day 0	Blood test
Magnesium	Day 0	Blood test
Creatinine	Day 0	Blood test
Bone alkaline phosphatase isoenzymes	Day 0	Blood test
Creatinuria	Day 0	Urine test
Calciuria	Day 0	Urine test

Secondary Outcome Measures

Name	Time	Method
Follicle stimulating hormone	Day 0	Blood test, patients under macro progestin treatment at day 0
Gonadotrophin b LH	Day 0	Blood test, patients under macro progestin treatment at day 0
Clinical tolerance of treatment	Day 0	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.
Estradiol	Day 0	Blood test, patients under macro progestin treatment at day 0

Trial Locations

Locations (1)

Hôpital Necker-Enfants Malades; 🇫🇷 Paris, France