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

Overview

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.

Full Title of Study: “Bone Health in Adolescents and Young Adults With Oral Macro-progestin Treatment : Observational Study”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: February 2021

Interventions

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

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: Female

Macroprogestins treatment.

Minimum Age: 16 Years

Maximum Age: 25 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Assistance Publique – Hôpitaux de Paris
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Sabrina Da Costa, MD, Study Director, Hôpital Necker-Enfants Malades
  • Overall Contact(s)
    • Maud Bidet, MD, 1 71 19 64 38, maud.bidet@aphp.fr

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