Skip to content

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

Retrospective Observational Evaluation of the Bone Mineral Density Outcome of Different Oestrogen Therapy Regimens in Young Women With Amenorrhea

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07015476
Enrollment
180
Registered
2025-06-11
Start date
2020-11-09
Completion date
2026-11-30
Last updated
2025-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amenorrhea

Keywords

Amenorrhea, Bone Mass, Estrogen Therapy

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

Interventions

None listed

Sponsors

IRCCS Azienda Ospedaliero-Universitaria di Bologna
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
15 Years to 39 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Primary Outcome MeasureUntil the end of the study (1 year)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).

Secondary

MeasureTime frameDescription
GAGs and Ferriman ScoreUntil the end of the study (1 year)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.

Countries

Italy

Contacts

Primary ContactMaria C Meriggiola, MD
cristina.meriggiola@unibo.it0512144394

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026