An observational study in Acromegaly, sponsored by Istituto Auxologico Italiano. Recruiting at 1 site in Italy. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2025-08-03.
Sponsored by Istituto Auxologico Italiano · Observational
Acromegaly is a rare chronic disease due to excessive secretion of growth hormone (GH) and insulin-like growth factor-I (IGF-I), caused in over 98% of cases by GH-secreting pituitary adenoma. Prolonged exposure to GH/IGF-I excess is the cause of increased mortality and morbidity in these patients. Arthropathy occurs in about 75% of acromegalic patients. Any joint may be affected, with the development of osteoarthritis, arthralgia, and an increase in fracture risk.
The aims of the present project are to evaluate the dimensions of hands and feet with the 3D scanner method and to perform a quantitative analysis of movement through Gait Analysis technique in de novo patients with acromegaly (group # 1) and in patients with different disease status (group #2).
This is an observational, prospective study that aims to evaluate the effect of acromegalic disease and medical/surgical therapy on acral morpho-functional alterations.
To outline the morphological characteristics of the extremities (hands and feet), a three-dimensional laser scanning system will be used able to measure the geometrical and volumetric characteristics of the hands and feet of these subjects. The three-dimensional scanning system that will be used is the portable FastScan system (marketed by Rodin), previously used for the volumetric evaluation of the lower and upper limbs of subjects suffering from lymphedema and lipedema. The processing of the image and the parameters will be carried out through two softwares: Rodin4DScan, which carries out the reconstruction of the shape after the scan, and Rodin4D, which allows the construction of the final shape and allows the processing of the various parameters to the morphology of the extremity.
The following tests will be used to characterize posture and balance control during walking:
The instrumentation (BTS GAITLAB) that will be used consists of:
The variables analyzed will be divided according to the administered tests:
A functional evaluation of the foot will be also performed positioning the patient prone/supine on the bed and measuring several joint angles.
The measurement will be supported by a video from which images can be subsequently processed to trace and obtain the joint angles.
For the functional evaluation of the hand, the patient will be evaluated with the following outcome measures:
202 studies on the registry are indexed under Acromegaly; 19 are open to participants now.
This study's planned enrollment of 30 is below the median of 100 across 81 observational studies indexed under Acromegaly.
Browse Acromegaly studies →Istituto Auxologico Italiano is the lead sponsor of 202 studies on the registry; 68 are open to participants now.
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Group #1: De novo patients with acromegaly, diagnosed according to Endocrine Society guidelines, aged equal or above 18 years old;
Group #2: Acromegalic patients with different disease status (active disease despite ongoing therapies, controlled disease under medical therapy, and disease remission), aged equal or above 18 years old
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
De novo patients with acromegaly, diagnosed according to Endocrine Society guidelines, aged equal or above 18 years old
Procedure: Medical surgery therapy
Acromegalic patients with different disease status (active disease despite ongoing therapies, controlled disease under medical therapy, and disease remission), aged equal or above 18 years old
De novo patients with acromegaly will undergo medical/surgical therapy of this disease, according to the guidelines of the Endocrine Society. In this population (group #1) morpho-functional examinations together with the evaluation of the stage of the disease, with serum dosage of GH and IGF-1, will be performed at baseline and at months 3, 6 and 12 after initiating the treatment.
Change in serum concentration of GH and IGF1
Serum concentration of GH and IGF1
Time frame: At baseline in population #1 and # 2 and at 3, 6, 12 months after intervention in population #1
Change in postural
The postural evaluation was performed for 60 seconds while the participants were standing on a baropodometric platform (P-Walk, BTSBioengineering, Italy). They were instructed to maintain an upright position, with their eyes focused on a 6 cm black circle placed at their individual eye level, at a distance of 1.5 meters. Subsequently, they were asked to repeat the same task with their eyes closed. To avoid any learning or fatigue effects, two evaluations were acquired with open eyes and two with closed eyes, and between each trial, the subjects were allowed to rest and sit for 2 minutes, maintaining the foot position during the tests. Postural parameters were calculated using dedicated software (G-Studio, BTS, Italy). The relative range of the center of pressure track length is essentially the difference between the maximum and minimum CoP position in the anterior-posterior and medial-lateral (ML) directions during the maintenance of the upright posture.
Time frame: At baseline in population #1 and # 2 and at 3, 6, 12 months after intervention in population #1
Gait analysis
All participants were evaluated with 3D-Gait Analysis using an optoelectronic system composed of eight cameras (SMARTDX, BTSBioengineering, Italy) set at 100 Hz, and two force platforms (AMTI, USA). To evaluate the kinematics of each body segment, passive markers were positioned on the participants' body, as described by Davis III et al., and the underlying skeletal model was scaled on behalf of anthropometric data (height, weight, tibial length, distance between the femoral condyles or diameter of the knee, distance between the malleoli or diameter of the ankle, distance between the anterior iliac spines and thickness of the pelvis). After placing the markers, the participants were asked to walk barefoot at self-selected speed along a walkway where the force platforms were embedded. Kinematic and kinetic data were collected for each individual from at least five trials to guarantee the reproducibility of the results.
Time frame: At baseline in population #1 and # 2 and at 3, 6, 12 months after intervention in population #1
Change in function of the foot - angle ankle joint
The functional evaluation of the foot involves positioning the patient prone/supine on the bed and assessing the ankle joint
Time frame: At baseline in population #1 and # 2 and at 3, 6, 12 months after intervention in population #1
Change in function of the foot - angle subtalar joint
The functional evaluation of the foot involves positioning the patient prone/supine on the bed and assessing the subtalar joint
Time frame: At baseline in population #1 and # 2 and at 3, 6, 12 months after intervention in population #1
Change in function of the foot - angle metatarsophalangeal joint of the big toe
The functional evaluation of the foot involves positioning the patient prone/supine on the bed and assessing the metatarsophalangeal joint of the big toe
Time frame: At baseline in population #1 and # 2 and at 3, 6, 12 months after intervention in population #1
Change in Function of the hand - Dreiser functional index
Algo-functional index of the hand according to Dreiser functional index
Time frame: At baseline in population #1 and # 2 and at 3, 6, 12 months after intervention in population #1
Change in Function of the hand - Duruöz hand index
Algo-functional index of the hand according to Duruöz hand index
Time frame: At baseline in population #1 and # 2 and at 3, 6, 12 months after intervention in population #1
Started Jun 2019 (actual). Primary completion is estimated for Dec 2025, 78 months after the start.
Of 26 observational studies under Acromegaly, half reached primary completion within 85 months of starting (the median), counting those still running; a quarter within 38 and three quarters within 263. This study's planned 78 months is close to that.
How these figures are worked out, and which studies are left out of them.
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