Bone Health in Adolescents and Young Adults With Oral Macro-progestin Treatment
NCT ID: NCT04007614
Last Updated: 2025-11-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
OBSERVATIONAL
2020-04-30
2021-02-28
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Patients
Patients who have taken a macro progestin treatment for more than 6 months between 16 and 25 years of age.
Questionnaire
Fardellone questionnaire (evaluation of calcium intake) Tolerance of treatment
Interventions
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Questionnaire
Fardellone questionnaire (evaluation of calcium intake) Tolerance of treatment
Eligibility Criteria
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Inclusion Criteria
* 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
16 Years
25 Years
FEMALE
No
Sponsors
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URC-CIC Paris Descartes Necker Cochin
OTHER
Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Principal Investigators
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Sabrina Da Costa, MD
Role: STUDY_DIRECTOR
Hôpital Necker-Enfants Malades
Locations
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Hôpital Necker-Enfants Malades
Paris, Paris, France
Countries
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Other Identifiers
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IDRCB : 2019-A00340-57
Identifier Type: OTHER
Identifier Source: secondary_id
APHP190093
Identifier Type: -
Identifier Source: org_study_id
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