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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Contraception; Macro-progestins
• Intervention / Treatment: Other: Questionnaire

• Study Type: Observational

Contacts and Locations

Study Locations

• France
  • Paris, France, 75015
    • Hopital Necker-Enfants Malades

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 23 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Patients followed by the department of endocrinology, gynecology and pediatric diabetes of Necker hospital.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients; Patients who have taken a macro progestin treatment for more than 6 months between 16 and 25 years of age.	Other: Questionnaire; Fardellone questionnaire (evaluation of calcium intake) Tolerance of treatment

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Follicle stimulating hormone	Blood test, patients under macro progestin treatment at day 0	Day 0
Gonadotrophin b LH	Blood test, patients under macro progestin treatment at day 0	Day 0
Estradiol	Blood test, patients under macro progestin treatment at day 0	Day 0

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Study Director: Sabrina Da Costa, MD, Hopital Necker-Enfants Malades

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2020
• Primary Completion (Anticipated): February 1, 2021
• Study Completion (Anticipated): February 1, 2021

Study Registration Dates

• First Submitted: April 17, 2019
• First Submitted That Met QC Criteria: July 2, 2019
• First Posted (Actual): July 5, 2019

Study Record Updates

• Last Update Posted (Actual): November 8, 2022
• Last Update Submitted That Met QC Criteria: November 7, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Bone health; Macro-progestins
• Other Study ID Numbers: APHP190093; IDRCB : 2019-A00340-57 (Other Identifier: ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No