Acromegaly: Balance, Falls and Fracture Risk

NCT05752825 | Completed

• 1 other identifier: N-20220041
• Study Type: observational
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational, cross-sectional study is to study bone quality, joint quality and fall risk in acromegalic patients, compared with healthy controls. The main questions it aims to answer are:

• what is the optimal method for evaluating bone quality and fracture risk in acromegalic patients?
• are acromegalic patients at increased risk of falling?
• is HR-pQCT a feasible method for evaluating acromegalic joint disease? Participants will undergo HR-pQCT scans, DXA scans, OsteoProbe examination and fall risk assessments. Results will be compared to matched healthy controls.

Conditions

Acromegaly

Keywords

Joint disease; Bone disease; Fall risk; Fracture risk

Outcome Measures

Primary Outcomes (3)

• Bone material strength index

  Measured by micro indentation

  20 min

• Volumetric BMD

  Measured by HR-pQCT

  30 min

• Area BMD

  Measured by DXA

  50 min

Secondary Outcomes (4)

• Balance (center of pressure and sway)

  20 min

• Visual acuity

  15 min

• Nerve conduction velocity

  5 min

• Muscle strength

  10 min.

Study Arms (2)

Acromegalic patients

Subjects with acromegaly

Radiation: HR-pQCT; Radiation: DXA scan; Diagnostic Test: Bone microindentation; Diagnostic Test: Hand grip and leg extension strength; Diagnostic Test: Timed up-and-go test; Diagnostic Test: Stabilometry; Diagnostic Test: Nerve conduction test; Diagnostic Test: Visual acuity test

Healthy controls

Subjects without acromegaly

Radiation: HR-pQCT; Radiation: DXA scan; Diagnostic Test: Bone microindentation; Diagnostic Test: Hand grip and leg extension strength; Diagnostic Test: Timed up-and-go test; Diagnostic Test: Stabilometry; Diagnostic Test: Nerve conduction test; Diagnostic Test: Visual acuity test

Interventions

HR-pQCT RADIATION

HR-pQCT is a 3-dimensional imaging modality that can be applied to bone and joints in vivo, in order to non-invasively assess the quantity and quality of trabecular and cortical bone compartments separately. HR-pQCT will be applied to peripheral skeletal sites, namely the distal radius and tibia, where image slices equivalent to 9 mm of bone will be acquired. From this, parameters such as volumetric bone mineral density (vBMD), cortical density, cortical porosity, trabecular density, trabecular thickness, trabecular spacing and others will be calculated using specialized software. In the same scanning session, images of the wrist and ankle joints will be produced and analyzed for features of arthrosis, such as erosions, osteophytosis and others.

Also known as: High Resolution peripheral Quantitative Computed Tomography

Acromegalic patients; Healthy controls

DXA scan RADIATION

Through DXA scans, we will obtain information regarding body composition, hip and spine bone mineral density, as well as examine any previous vertebral fractures using vertebral fracture assessment (VFA). VFA is a function of DXA scanners which allows for visualization of thoracic and lumbar vertebrae (usually T4-L4) in order to detect vertebral fractures34. Vertebral fractures can then be classified as either mild, moderate or severe using the method described by Genant et al35.

Also known as: Dual X-ray Absorptiometry

Acromegalic patients; Healthy controls

Bone microindentation DIAGNOSTIC_TEST

Using the OsteoProbe®, we will by microindentation measure the bone material strength index (BMSi), an in vivo surrogate measure of the fracture resistance of the cortical bone in the tibia. The participant is placed in a supine position with the examined leg rotated slightly outward. After identifying the site of interest, located midway between the medial tibial plateau and the medial malleolus, disinfectant is applied to the skin of the tibia being examined. Finally, under local anesthesia and fully sterile conditions, a test probe is inserted through the skin and onto the midshaft of the tibia, and the fracture resistance of the bone tissue is measured.

Also known as: OsteoProbe

Acromegalic patients; Healthy controls

Hand grip and leg extension strength DIAGNOSTIC_TEST

Hand grip strength will be assessed using a digital hand dynamometer as a measure of peripheral muscle strength. Leg extensor strength will be examined using the peak torque measured by an isometric dynamometer mounted on a fixed chair. 3 attempts will be given for each method, and the maximum value recorded.

Acromegalic patients; Healthy controls

Timed up-and-go test DIAGNOSTIC_TEST

The TUG test is a functional test frequently used to assess balance in older individuals and is performed by measuring the time it takes for an individual to go from sitting to standing position, walk 3 meters, turn around and return to sitting position. A TUG score of \>13,5 seconds is associated with an increased risk of falls.

Acromegalic patients; Healthy controls

Stabilometry DIAGNOSTIC_TEST

Postural control will be assessed by means of a force platform that registers Center of Pressure (CoP) as a measure of postural stability. Measurements are performed under a variety of conditions, including eyes open/closed and on different surfaces. From the CoP measurements, parameters such as CoP range and CoP velocity in both antero-posterior and medial-lateral directions will be calculated using specialized software.

Also known as: Balance board

Acromegalic patients; Healthy controls

Nerve conduction test DIAGNOSTIC_TEST

To fully examine all components of balance, nerve conduction will be tested using a handheld device called NC-stat DPN-Check in order to assess any peripheral neuropathy.

Acromegalic patients; Healthy controls

Visual acuity test DIAGNOSTIC_TEST

Visual acuity will be tested using an automated refractometer (KR-800S Auto-kerato-refractometer, Topcon Healthcare, The Netherlands).

Acromegalic patients; Healthy controls

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with acromegaly who attend the Neuroendocrinology outpatient clinic at Aalborg University Hospital, Denmark.

You may qualify if:

• Verified acromegaly diagnosis
• Age \>18 years
• Ability to provide informed consent
• Ability to stand on both legs for \>5 minutes at a time and walk \>6 meters
• Patient is eugonadal, either naturally or by hormone replacement therapy

You may not qualify if:

• Established diagnosis of severe kidney or liver dysfunction, malabsorption, multiple myeloma or other diseases associated with reduced bone quality
• Treatment with supraphysiological doses of glucocorticoids or other drugs that impair bone quality
• Diagnosis of rheumatoid arthritis, psoriatic arthritis or other joint diseases unrelated to acromegaly
• Active drug or alcohol abuse
• Pregnancy
• Known allergy/hypersensitivity to local anaesthetics or disinfectant
• Other factors that render the subject unable to participate in the clinical study, based on the judgment of the investigator(s)

Sponsors & Collaborators

• Christian Alexander H Rosendal: lead
• Ipsen: collaborator
• Pfizer: collaborator

Study Sites (1)

Aalborg University Hospital

Aalborg, North Denmark, 9000, Denmark

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood samples will be stored in a research biobank for future analysis.

MeSH Terms

Conditions

Acromegaly; Joint Diseases; Bone Diseases

Interventions

Absorptiometry, Photon; Nerve Conduction Studies

Condition Hierarchy (Ancestors)

Bone Diseases, Endocrine; Musculoskeletal Diseases; Hyperpituitarism; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Densitometry; Photometry; Chemistry Techniques, Analytical; Investigative Techniques; Diagnostic Techniques, Neurological; Electrodiagnosis

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, PhD student at dept. of Endocrinology

Study Record Dates

• First Submitted: February 22, 2023
• First Posted: March 3, 2023
• Study Start: June 2, 2023
• Primary Completion: May 15, 2024
• Study Completion: May 15, 2024
• Last Updated: May 16, 2024

Record last verified: 2024-05

Locations

DK (1)