Retrospective Observational Evaluation of the Bone Mineral Density Outcome in Young Women With Amenorrhea

ConditionAmenorrhea
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age15-39
SponsorIRCCS Azienda Ospedaliero-Universitaria di Bologna

About this trial

The study aims to evaluate the outcomes of different estrogen therapy regimens in patients with amenorrhea who face prolonged periods of hypoestrogenism.

The primary objective is to compare the outcomes on bone mass of different therapeutic regimens and identify more favorable. For this purpose, densitometry parameters such as BMD, T-score and Z-score at the level of the lumbar spine, femur and entire skeleton will be considered, comparing a bone densitometry (DXA technique, Dual X-ray Absorptiometry) Baseline with one carried out after at least one year of therapy. The secondary objective of the study is to assess other systemic/metabolic implications of the different therapies.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients who have presented themselves to the O.U. of Gynecology and Human Reproduction Pathophysiology in the period from 2011 to 2020 with amenorrhea over 6 months, and aged between 15 and 39 years at the time of the visit.

Patients who have reached the age of 18 at the time of surgery.

Patients for whom informed consent has been obtained.

Disqualifiers

None

Trial population

The present retrospective observational study, monocentric, involves the recruitment of patients who have presented themselves to the U.O. of Gynecology and Pathophysiology of Human Reproduction in the time interval between 2011 and 2020 in condition of amenorrhea above 6 months, Aged between 15 and 39 at the time of first visit. Patients will be asked to participate in this study during the outpatient follow-up visit. The study will involve data collection through consultation of health records.

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

Not listed

Trial groups

180 Participants
are grouped into 4 trial groups
Group A: GROUP A
Group B: GROUP B
Group C: GROUP C
Group D: GROUP D

Trial outcomes

Primary outcomes

1

Primary Outcome Measure

The objectives of the study will be achieved by analysing the following parameters: Collection of anamnestic (eating habits and sports, pathologies of importance, medication intake, previous surgical interventions, smoking habit, gynecological history).

Time frame
Until the end of the study (1 year)
2

Primary Outcome Measure

The objectives of the study will be achieved by analysing the following parameters: Physical examination: calculation of BMI (weight Kg/(height meters \* height in meters), blood pressure (mm Hg)

Time frame
Until the end of the study (1 year)
3

Primary Outcome Measure

The objectives of the study will be achieved by analysing the following parameters: Transvaginal or transabdominal pelvic ultrasound (Uterus measures mm; endometrium thickness mm; ovary size volume cc and mesures mm)

Time frame
Until the end of the study (1 year)
4

Primary Outcome Measure

The objectives of the study will be achieved by analysing the following parameters: Lumbar, femoral, total body dual-energy x-ray absorptiometry (DXA): BMD (g/cm2); T score e Z score.

Time frame
Until the end of the study (1 year)

Secondary outcomes

1

GAGs and Ferriman Score

For Acne: The GAGS divides the face (forehead, each cheek, nose, and chin), chest, and back into six areas, and the severity in each zone is then assessed on a scale of 0 to 4 (0, no lesions; 1, comedones; 2, papules; 3, pustules; and 4, nodules.

Time frame
Until the end of the study (1 year)
2

GAGs and Ferriman Score

For Hirsutism: The Ferriman-Gallwey is widely used to evaluate and quantify hirsutism in women. The method incorporates nine body regions (excludes legs and forearms) for the assessment of hair growth, rated from 0 (no growth of terminal hair) to 4 (extensive hair growth) in each of the nine locations. The total score therefore can range from 0 to 36 and a score of \> 8 is considered a sign of androgen excess in Caucasian women. A score of 8 -15 indicates mild hirsutism and \>15 indicates moderate or severe hirsutism. For other ethnic groups, the amount of hair expected for that ethnicity should be considered.

Time frame
Until the end of the study (1 year)

Other outcomes

Sponsors and contacts

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