RecruitingNCT06344650

Cellular, Molecular and Clinical Determinants of Bone Strength in in Vivo and Human Models of GH Excess.

Cellular, Molecular and Clinical Determinants of Bone Strength in in Vivo and Human Models of GH Excess. Cross-sectional and Prospective Study


Sponsor

IRCCS San Raffaele

Enrollment

100 participants

Start Date

Apr 30, 2023

Study Type

OBSERVATIONAL

Conditions

Summary

Prospective observational clinical, molecular, translational study aimed at identifying the main determinants and predictive factors of fragility fracture risck in acromegaly patients


Eligibility

Min Age: 18 Years

Inclusion Criteria3

  • confirmed diagnosis of acromegaly
  • availability to carry out outpatient checks
  • ability to provide informed consent

Exclusion Criteria9

  • Pregnancy
  • use of glucocorticoids (except those in use for replacement therapy)
  • alcohol abuse
  • exacerbation of chronic disease
  • serious comorbidities (renal or hepatic failure, heart attack, stroke)
  • terminally ill, prolonged immobilization (>1 week)
  • clinically evident fracture within the previous six months
  • any other cause of secondary osteoporosis within the last five years
  • any prolonged treatment with drugs with documented influence on bone metabolism during the previous 12 months, including treatment with antiresorptive or anabolic compounds for osteoporosis.

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Interventions

PROCEDUREBlood sample

Collection of blood serum for molecular and biochemical tests

DIAGNOSTIC_TESTRadiological tests

Performance of radiological tests (DXA, VFA, TBS, BSi, HR-pQCT) and DXA morphometry

OTHERQuestionnaires

Compilation of questionnaires (AcroQol, SF-36)


Locations(1)

Andrea Giustina

Milan, Italy

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NCT06344650


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