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

A

Assistance Publique - Hôpitaux de Paris

Status

Withdrawn

Conditions

Macro-progestins
Contraception

Treatments

Other: Questionnaire

Study type

Observational

Funder types

Other

Identifiers

NCT04007614
APHP190093
IDRCB : 2019-A00340-57 (Other Identifier)

Details and patient eligibility

About

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.

Sex

Female

Ages

16 to 25 years old

Volunteers

No Healthy Volunteers

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

Trial design

0 participants in 1 patient group

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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