NCT04007614

Brief 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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 17, 2019

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 5, 2019

Completed
9 months until next milestone

Study Start

First participant enrolled

April 1, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2021

Completed
Last Updated

November 20, 2025

Status Verified

November 1, 2022

Enrollment Period

10 months

First QC Date

April 17, 2019

Last Update Submit

November 17, 2025

Conditions

ContraceptionMacro-progestins

Keywords

Macro-progestinsBone health

Outcome Measures

Primary Outcomes (15)

  • 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 Outcomes (4)

  • Clinical tolerance of treatment

    Day 0

  • Follicle stimulating hormone

    Day 0

  • Gonadotrophin b LH

    Day 0

  • Estradiol

    Day 0

Study Arms (1)

Patients

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

Other: Questionnaire

Interventions

QuestionnaireOTHER

Fardellone questionnaire (evaluation of calcium intake) Tolerance of treatment

Patients

Eligibility Criteria

Age16 Years - 25 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsMacroprogestins treatment.
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • Patients with a pathology or treatment that can alter bone mineral density

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Necker-Enfants Malades

Paris, Paris, 75015, France

Location

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Sabrina Da Costa, MD

    Hôpital Necker-Enfants Malades

    STUDY DIRECTOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2019

First Posted

July 5, 2019

Study Start

April 1, 2020

Primary Completion

February 1, 2021

Study Completion

February 1, 2021

Last Updated

November 20, 2025

Record last verified: 2022-11

Locations

FR(1)