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

Condition(s) studied

Study 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.

Eligibility

Primary outcome measure(s)

• Primary Outcome Measure — Until 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).
• Primary Outcome Measure — Until the end of the study (1 year)
  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)
• Primary Outcome Measure — Until the end of the study (1 year)
  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)
• Primary Outcome Measure — Until the end of the study (1 year)
  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.
• Primary Outcome Measure — Until the end of the study (1 year)
  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

Trial sites (1)

More IRCCS Azienda Ospedaliero-Universitaria di Bologna trials in Italy