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

NCT07015476 | Recruiting

• 1 other identifier: AMEN-20
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Amenorrhea

Keywords

Amenorrhea; Bone Mass; Estrogen Therapy

Outcome Measures

Primary Outcomes (5)

• 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).

  Until the end of the study (1 year)

• 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)

  Until the end of the study (1 year)

• 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)

  Until the end of the study (1 year)

• 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.

  Until the end of the study (1 year)

• Primary Outcome Measure

  Blood tests: hemoglobin (g/gl), hematocrit (%),red blood cells (million/µl), Platelets (x1000/ µl), Glucose (mg/dl), Alt (U/L), Ast (U/L), triglycerides (mg/dl), Total cholesterol (mg/dl), HDL Cholesterol (mg/dl), LH (mU/ml), FSH (mU/ml), Testosteron (ng/ml), Proladctin ( ng/ml), Estradiol (pg/ml); Urinalysis: PH, proteins(mg/dl) Glucose (mg/dl), Red blood cells (num/microL), Leukocytes

  Until the end of the study (1 year)

Secondary Outcomes (2)

• GAGs and Ferriman Score

  Until the end of the study (1 year)

• GAGs and Ferriman Score

  Until the end of the study (1 year)

Study Arms (4)

GROUP A

Natural estrogen (estradiol or valerate estradiol) administered transdermically

GROUP B

Natural estrogen administered orally

GROUP C

Etinil-estradiol administered orally

GROUP D

No therapy

Eligibility Criteria

• Age: 15 Years - 39 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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.

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

IRCCS Azienda Ospedaliero -Univeristaria di Bologna

Bologna, 40138, Italy

RECRUITING

MeSH Terms

Conditions

Amenorrhea

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Maria C Meriggiola, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria C Meriggiola, MD

CONTACT

0512144394; cristina.meriggiola@unibo.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2024
• First Posted: June 11, 2025
• Study Start: November 9, 2020
• Primary Completion: October 1, 2025
• Study Completion (Estimated): November 1, 2026
• Last Updated: June 11, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)