Clinical trial NCT07015476: Retrospective Observational Evaluation of the Bone Mineral Density Outcome in Young Women With Amenorrhea
Official title: Retrospective Observational Evaluation of the Bone Mineral Density Outcome of Different Oestrogen Therapy Regimens in Young Women With Amenorrhea
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Amenorrhea
Keywords: Amenorrhea
Bone Mass
Estrogen Therapy
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2025-06-11
Enrollment: 180
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 39
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study 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.

Brief summary: 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.

Detailed description: The present retrospective monocentric observational study involves the recruitment of patients afferite at the U.O. of Gynecology and Physiopathology of Human Reproduction in the time interval between 2011 and 2020 in condition of amenorrhea greater than 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.

The objectives of the study will therefore be achieved by analysing the following parameters, which can be fully deduced from the medical records of the subjects in the study:

* Collection of anamnestic (eating habits and sports, pathologies of note, taking drugs, previous surgical interventions, smoking habit, gynecological history).
* Physical examination: calculation of BMI, acne and hirsutism score (GAGS and Ferriman score), blood pressure measurement, gynecological physical examination
* Transvaginal or transabdominal pelvic ultrasound
* Lumbar, femoral, total body dual-energy x-ray absorptiometry (DXA)
* Blood tests (blood count, lipid profile, glycemic, liver, kidney, hormonal status)
* Reports of other visits and specialist examinations performed by the patients brought to view during the visit

Eligibility criteria: Inclusion criteria:

* 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.

Exclusion criteria: No exclusion criteria are provided.

Primary outcomes:
measure: Primary Outcome Measure
timeFrame: Until the end of the study (1 year)
measure: Primary Outcome Measure
timeFrame: Until the end of the study (1 year)
measure: Primary Outcome Measure
timeFrame: Until the end of the study (1 year)
measure: Primary Outcome Measure
timeFrame: Until the end of the study (1 year)
measure: Primary Outcome Measure
timeFrame: Until the end of the study (1 year)
Secondary outcomes:
measure: GAGs and Ferriman Score
timeFrame: Until the end of the study (1 year)
measure: GAGs and Ferriman Score
timeFrame: Until the end of the study (1 year)
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS Azienda Ospedaliero -Univeristaria di Bologna
Study officials:
affiliation: IRCCS Azienda Ospedaliero-Universitaria di Bologna
name: Maria C Meriggiola, MD
role: PRINCIPAL_INVESTIGATOR
References: