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

Contraception Clinical Trial

— MACROS  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04007614
• Other study ID #: APHP190093
• Secondary ID: IDRCB : 2019-A00
• Status: Withdrawn
• 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
• 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• Status: Withdrawn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

Related Conditions & MeSH terms

• Contraception
• Macro-progestins

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