Recruiting NCT06344650
Cellular, Molecular and Clinical Determinants of Bone Strength in in Vivo and Human Models of GH Excess.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Blood sample, Radiological tests, Questionnaires.
- Who it may be relevant to
- Registry conditions: Acromegaly. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Cellular, Molecular and Clinical Determinants of Bone Strength in in Vivo and Human Models of GH Excess. Cross-sectional and Prospective Study
Overview
Prospective observational clinical, molecular, translational study aimed at identifying the main determinants and predictive factors of fragility fracture risck in acromegaly patients
Interventions
- Procedure Blood sample
Collection of blood serum for molecular and biochemical tests - Diagnostic test Radiological tests
Performance of radiological tests (DXA, VFA, TBS, BSi, HR-pQCT) and DXA morphometry - Other Questionnaires
Compilation of questionnaires (AcroQol, SF-36)
Primary outcome measures
- Identify the rate of morphometric vertebral fractures in acromegalic patients [Time frame: 18 months]
Eligibility criteria
Inclusion criteria
- confirmed diagnosis of acromegaly
- availability to carry out outpatient checks
- ability to provide informed consent
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Case-crossover
Study locations
Italy · 1 center
- Andrea Giustina — Milan
Identifiers
NCT: NCT06344650 · RF-2021-12373584