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Trial record 73 of 108 for:    CALCIUM CATION

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

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ClinicalTrials.gov Identifier: NCT04007614
Recruitment Status : Not yet recruiting
First Posted : July 3, 2019
Last Update Posted : July 3, 2019
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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.


Condition or disease Intervention/treatment
Contraception Macro-progestins Other: Questionnaire

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Bone Health in Adolescents and Young Adults With Oral Macro-progestin Treatment : Observational Study
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020

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




Primary Outcome Measures :
  1. Bone densitometry [ Time Frame: Day 0 ]
    Z score values compared to the reference values

  2. Calcemia [ Time Frame: Day 0 ]
    Blood test

  3. Ionized calcium [ Time Frame: Day 0 ]
    Blood test

  4. Phosphor [ Time Frame: Day 0 ]
    Blood test

  5. Magnesium [ Time Frame: Day 0 ]
    Blood test

  6. Albumin [ Time Frame: Day 0 ]
    Blood test

  7. Parathormone [ Time Frame: Day 0 ]
    Blood test

  8. 25 OH vitamin D3 [ Time Frame: Day 0 ]
    Blood test

  9. Creatinine [ Time Frame: Day 0 ]
    Blood test

  10. Osteocalcin [ Time Frame: Day 0 ]
    Blood test

  11. Bone alkaline phosphatase isoenzymes [ Time Frame: Day 0 ]
    Blood test

  12. C-terminal telopeptide of type I collagen [ Time Frame: Day 0 ]
    Blood test

  13. Calciuria [ Time Frame: Day 0 ]
    Urine test

  14. Natriuresis [ Time Frame: Day 0 ]
    Urine test

  15. Creatinuria [ Time Frame: Day 0 ]
    Urine test


Secondary Outcome Measures :
  1. 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.

  2. Follicle stimulating hormone [ Time Frame: Day 0 ]
    Blood test, patients under macro progestin treatment at day 0

  3. Gonadotrophin b LH [ Time Frame: Day 0 ]
    Blood test, patients under macro progestin treatment at day 0

  4. Estradiol [ Time Frame: Day 0 ]
    Blood test, patients under macro progestin treatment at day 0



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Ages Eligible for Study:   16 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Macroprogestins treatment.
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients followed by the department of endocrinology, gynecology and pediatric diabetes of Necker hospital.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04007614


Contacts
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Contact: Maud Bidet, MD 1 71 19 64 38 maud.bidet@aphp.fr
Contact: Hélène Morel 1 71 19 63 46 ext +33 helene.morel@aphp.fr

Locations
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France
Hôpital Necker-Enfants Malades Not yet recruiting
Paris, France, 75015
Contact: Maud Bidet, MD    1 71 19 64 38 ext +33    maud.bidet@aphp.fr   
Contact: Hélène Morel    1 71 19 63 46 ext +33    helene.morel@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Study Director: Sabrina Da Costa, MD Hôpital Necker-Enfants Malades

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT04007614     History of Changes
Other Study ID Numbers: APHP190093
IDRCB : 2019-A00340-57 ( Other Identifier: ANSM )
First Posted: July 3, 2019    Key Record Dates
Last Update Posted: July 3, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Macro-progestins
Bone health
Additional relevant MeSH terms:
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Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs