Mean Height Gain Research Articles

Autologous leucocyte and platelet rich in fibrin (L-PRF) - is it a competitive solution for bone augmentation in maxillary sinus lift? A 6-month radiological comparison between xenografts and L-PRF.

Much of the research published involves using artificial products, like xenografts and resorbable collagen membranes, after a prior Cone Beam Computer Tomography (CBCT) investigation. Nowadays, more accessible access, less financial costs, a biological approach, and faster healing are objectives that surround this procedure. Leucocytes and platelets rich in Fibrin (L-PRF) are a natural component with a high concentration of growth factors. Due to its regenerative properties and lack of complications, it is used in several medical fields, like orthopedics, dermatology, and oral surgery. This retrospective study aims to compare results in bone height and volume obtained through external sinus lift, either by using xenografts or autologous plasma rich in fibrin, by evaluating the quantity of new bone formation from a radiological point of view. Fifty-eight Caucasian patients were included in this retrospective study; 48 were submitted to xenograft procedure, and 10 were selected for L-PRF grafting material with simultaneous implant placement. Lack of clinical and histological studies performed on patients with L-PRF surgeries limited us in choosing a larger group for the radiological analysis. CBCT evaluation was performed before surgery and 6 months after. All patients selected for the study presented good general and oral health, acute oral and sinus infections excluded; smoking and periodontal disease were also criteria of exclusion. Two operators performed the measurements in pre-established landmarks in different time frames. The two independent groups were compared with the Wilcoxon rank-sum test for quantitative data. Qualitative characteristics were described as counts and percentages. All analyses were performed in an R environment for statistical computing and graphics. Mean bone height gain in the xenograft group in the regions was as follows: 7.44 for the anterior landmark, 12.14 for the median and 8.28 for the distal. The mean group height gained for the L-PRF group was 0.1 anteriorly, -0.18 for the median measurement, and 0.23 distally. We obtained excellent overall reliability for all the height measurements between the two operators. Further studies must be conducted to establish new sets of surgical protocols in case L-PRF alone is found to be a reliable, stable, biological alternative to the well-documented xenografts in external sinus lifts. Radiological results, although promising, must be further applied in long term clinical survival of the implants in the grafted sites. Also, studies combining L-PRF in conjunction with xenograft might bring improved clinical results in terms of reduced postoperative complications and accelerated healing.

A Systematic Review of the Impact of Growth Hormone Therapy on Final Adult Height of Children with Idiopathic Short Stature

Abstract Introduction This review aims to systematically determine the effect of growth hormone (GH) therapy on adult height of children and adolescents with idiopathic short stature (ISS). Methods A systematic review was conducted to assess the effectiveness of GH therapy in children with ISS. Databases like ProQuest Central, journal @ Ovoid, EBSCOhost Medline Complete, Oxford University Press Journals, KB + JISC Collections Elsevier Science Direct Freedo, and BMJ, and cross-referencing of bibliographies were searched electronically. The randomized trials from 1989 to January 2023 were retrieved. Randomized trials with final adult height measurements and fit the inclusion criteria (height >2 standard deviation [SD] score below the mean with no comorbid conditions that would impair growth, peak growth hormone responses >10 μg/L, no previous history of GH therapy) were included in this review. The exclusion criteria are nonrandomized trials; trials include causes of short stature other than ISS, and studies include interventions other than GH and gonadotropin-releasing hormone analog (GnRH-a). A structured approach to the critical appraisal program by Oxford was used to analyze and extract the data. Results The study reviewed 14 eligible randomized trials, which recruited 2,206 assessable children for analysis. Seven trials compared different GH doses, four trials compared GH therapy with controls, and three trials compared a combination of GH and GnRH therapy with GH alone. Apart from one study, the overall dropout rate was not high. The high percentage of boys was a potential source of heterogeneity between trials. The change in height (HT)-SD score was 1.06 ± 0.30 and 0.18 ± 0.27 with treatment and control children, respectively, and the difference is statistically significant (p < 0.001). The overall mean height gain was 5 cm (0.84 SD score) more in treated children. The height velocity was found to be decreased significantly (p < 0.001) in the second and third years of treatment in the GH + GnRH-a treated group from 7 cm/year during the first year of treatment to 5.4 cm during the second year and 4.9 cm/year during the third year. They also found that using a higher dose of GH at 9 mg/m2/week leads to approximately 7 cm mean final height gain; however, lower dose regimens are less effective. Conclusion Although the magnitude of the effectiveness of GH therapy is, on average, less than that achieved in other conditions for which GH is licensed, GH therapy seems to be effective in children with idiopathic short stature, and it reduces the deficit in height as adults. Moreover, the effect seems to be dose-dependent, with better results at high GH doses, and the response variability is seen in different individuals. The use of combined GH with GnRH therapy needs to be balanced with their side effects.

Evolving growth hormone deficiency: proof of concept.

We present the evolution of GHD in adolescent males with persistent growth failure, in whom the diagnosis was established after a second GH stimulation test (GST). We performed a retrospective chart review of children who presented for short stature (height less < 2SD for mean/mid-parental height) and/or growth failure (sustained growth velocity < 0 SD) to pediatric endocrinology at Mount Sinai Kravis Children's Hospital, New York and who had 2 GSTs. Data collected from electronic medical records were analyzed using SPSS v28.0. Of 53 patients included, 42 were males. Average GH peak on initial GST was 15.48 ± 4.92 ng/ml, at 10.07 ± 2.65 years, mean height -1.68 ± 0.56SD(28% had <2SD), IGF-1 -1.00 ± 0.88SD. After 2.23 ± 1.22 years, at 12.04 ± 2.41years, height SDs decreased to -1.82 ± 0.63SD and IGF-1 was -1.08 ± 0.84SD. At repeat GST, average GH peak was 7.59 ± 2.12 ng/dL, with 36% ≤7 ng/dl and 32% in puberty. 12 males reached adult height of 0.08 ± 0.69 SD with a mean height gain of 1.83 ± 0.56SD(p<0.005), IGF-1 of -1.15 ± 0.81SD after 4.64 ± 1.4 years of GH. We offer evidence for Evolving Growth Hormone Deficiency (EGHD) through repeat GST in children with persistent growth slowdown, even with pubertal progression; emphasizing the need for careful longitudinal follow-up to make accurate diagnosis.

FRI598 Evolving Growth Hormone Deficiency: A Proof Of Concept

Abstract Disclosure: S. Chimatapu: None. S. Sethuram: None. J. Samuels: None. M. Savage: None. R. Rapaport: None. Introduction: Most cases of growth hormone deficiency (GHD) in pediatric patients are idiopathic, isolated and acquired. All acquired conditions commence with a period during which the diagnosis maybe unapparent. We document here evidence for evolution of GHD in a group of adolescent males who tested sufficient on initial GH stimulation test (GST) but tested deficient upon reevaluation. The rationale for repeat GST was ongoing growth failure. Hypothesis: We hypothesize that GHD in some individuals evolves with time and can be diagnosed by repeat testing (EGHD). We also postulate that their response to GH therapy is similar to other patients with GHD. Methods: We performed an IRB-approved retrospective chart review of children who presented for short stature (height less &amp;lt; 2SD for mean or &amp;lt; 2SD for mid-parental height) to pediatric endocrinology at Kravis Children’s Hospital at Mount Sinai, New York and who had 2 GST. GST were performed using two different stimuli (arginine and glucagon) and highly sensitive assay serum GH measurements were processed by the same laboratory, Esoterix. No patient had obesity, chronic illnesses, or any genetic conditions affecting growth. Data were collected from electronic medical records and analyzed using SPSS v28.0 once at least half the population studied reached adult height. We defined adult height as bone age ≥ 16 years and growth velocity ≤ 2 cm/year. Results: Of 42 charts analyzed, all male, 25 had EGHD. Their average GH peak on initial GST was 15.48 ± 4.92 ng/ml, mean age 10.07 ± 2.65 years, mean height -1.68 ± 0.56 SD , IGF-1 -1.00 ± 0.88 SD. After 2.23 ± 1.22 years, at 12.04 ± 2.41years, height decreased to -1.82 ± 0.63 SD and IGF-1 was -1.08 ± 0.84 SD. At repeat GST, GH peak was 7.59 ± 2.12 ng/mL and 28% were in puberty. All patients had MRI before starting GH therapy; 40% had small anterior pituitary glands. 12 males who reached adult height had a height of -1.88 ± 0.64 SD, IGF-1 of -1.15 ± 0.81 SD, with 42% pubertal and peak GH of 7.33 ± 2.47 ng/mL at repeat GST. They had a mean height gain of 1.83 ± 0.56 SD(p&amp;lt;0.005), with an adult height of 0.09 ± 0.70 SD after 4.64 ± 1.4years of treatment. They were 2.10 ± 4.20 cm taller than their mid-parental target heights. Discussion/Conclusions: We provide proof of concept for the diagnosis of EGHD. The diagnosis could be established by repeat GST in children with ongoing growth deceleration despite pubertal progression and a non-diagnostic initial GST. Our patients who reached adult height had a height gain consistent with that reported by KIGS for patients with growth hormone deficiency (1.7SD; Cutfield,1999) and indeed better than patients with ISS (0.7SD; Maghnie,2022). Presentation: Friday, June 16, 2023

Height Gain Following Correction of Adult Spinal Deformity.

Height gain following a surgical procedure for patients with adult spinal deformity (ASD) is incompletely understood, and it is unknown if height gain correlates with patient-reported outcome measures (PROMs). This was a retrospective cohort study of patients undergoing ASD surgery. Patients with baseline, 6-week, and subanalysis of 1-year postoperative full-body radiographic and PROM data were examined. Correlation analysis examined relationships between vertical height differences and PROMs. Regression analysis was utilized to preoperatively estimate T1-S1 and S1-ankle height changes. This study included 198 patients (mean age, 57 years; 69% female); 147 patients (74%) gained height. Patients with height loss, compared with those who gained height, experienced greater increases in thoracolumbar kyphosis (2.81° compared with -7.37°; p < 0.001) and thoracic kyphosis (12.96° compared with 4.42°; p = 0.003). For patients with height gain, sagittal and coronal alignment improved from baseline to postoperatively: 25° to 21° for pelvic tilt (PT), 14° to 3° for pelvic incidence - lumbar lordosis (PI-LL), and 60 mm to 17 mm for sagittal vertical axis (SVA) (all p < 0.001). The full-body mean height gain was 7.6 cm, distributed as follows: sella turcica-C2, 2.9 mm; C2-T1, 2.8 mm; T1-S1 (trunk gain), 3.8 cm; and S1-ankle (lower-extremity gain), 3.3 cm (p < 0.001). T1-S1 height gain correlated with the thoracic Cobb angle correction and the maximum Cobb angle correction (p = 0.002). S1-ankle height gain correlated with the corrections in PT, PI-LL, and SVA (p < 0.001). T1-ankle height gain correlated with the corrections in PT (p < 0.001) and SVA (p = 0.03). Trunk height gain correlated with improved Scoliosis Research Society (SRS-22r) Appearance scores (r = 0.20; p = 0.02). Patient-Reported Outcomes Measurement Information System (PROMIS) Depression scores correlated with S1-ankle height gain (r = -0.19; p = 0.03) and C2-T1 height gain (r = -0.18; p = 0.04). A 1° correction in a thoracic scoliosis Cobb angle corresponded to a 0.2-mm height gain, and a 1° correction in a thoracolumbar scoliosis Cobb angle resulted in a 0.25-mm height gain. A 1° improvement in PI-LL resulted in a 0.2-mm height gain. Most patients undergoing ASD surgery experienced height gain following deformity correction, with a mean full-body height gain of 7.6 cm. Height gain can be estimated preoperatively with predictive ratios, and height gain was correlated with improvements in reported SRS-22r appearance and PROMIS scores. Therapeutic Level III . See Instructions for Authors for a complete description of levels of evidence.

Risk factors and longitudinal regenerative outcomes of sinus membrane perforation during lateral window sinus floor elevation: A retrospective analysis up to 9 years.

Lateral-window sinus floor elevation (LSFE) is a reliable procedure to reconstruct the posterior maxilla for implant therapy. This retrospective study aimed to investigate risk factors associated with Schneiderian membrane perforation (SMP) occurrence during LSFE and longitudinal regenerative outcomes following LSFE up to 9 years. Patients who had LSFE between 2010 and 2019 were included. All demographic and surgical-related data were retrieved from existing electronic health records. Radiographs were used to evaluate the vertical dimensional changes of ridge and graft materials and the potential anatomic factors of SMP. A total of 122 LSFE procedures in 99 patients were included in the study. Mean ridge height gain and graft shrinkages were 9.5±3.47 and 1.57±2.85mm. The influence of the healing period on graft shrinkage showed a positive trend; the longer the healing period, the greater the graft shrinkage (p=0.09). The pathology in the sinus showed a positive correlation with SMP (p=0.07). However, other anatomical factors did not negatively impact SMP and subsequent ridge height gain (p>0.05). With inherent limitation, the findings with up to 9 years of follow-up indicate a consistent ridge remodeling lasting for about 3 years after LSFE procedures. SMP or membrane thickening may not significantly affect the ridge gain following LSFE. The healing period had the most significant influence on graft shrinkage, showing that the longer the healing time between LSFE and implant placement, the greater the graft shrinkage.

Adult Height in Indian Girls with Turner Syndrome Treated with Long-Term Growth Hormone Therapy - A Western India Tertiary Centre Experience.

Owing to paucity of data on adult height in Indian girls with Turner syndrome treated with growth hormone (GH), this study was conducted to assess improvement in height following GH therapy and adult height achieved with long-term GH therapy in Indian girls with Turner syndrome and to assess relationship between achieved and predicted height. Retrospective analysis was performed on 12 girls with karyotype-proven Turner syndrome, who had attained adult height following mean duration of GH therapy of 4.8 years (range: 2.7-7.6). Adult height predictions were performed using index of responsiveness (IOR) and Ranke's prediction model. Mean age at starting GH was 10.2 ± 1.9 years; Pubertal induction was between 11 and 15 years. Mean height gain was 29.3 ± 9.8 cm (range: 14-39.5) from onset of treatment to adult height. Significant improvement in height Z scores (IAP 2015 and Indian Turner reference data) following GH therapy (p = 0.002 and 0.012, respectively) was noted. Using Indian Turner reference data, the height Z score improved from pre-treatment 0.8 ± 0.8 to 2.0 ± 0.9 on stopping GH and adult height Z score of 1.3 ± 0.7. Using Ranke's equation for prediction of near adult height, predicted and achieved adult height showed a strong positive correlation (Spearman correlation coefficient = 0.827, significant at 0.01 level). At a dose in the lower range (40-50 mcg/kg/day) of recommendation and duration of 5 years, Indian girls with Turner syndrome can achieve adult height within the healthy Indian reference range. Dose individualization based on IOR would help in optimizing GH dosage and would turn out to be economically sustainable without compromising on height outcomes.

Height Gain After Spinal Fusion for Idiopathic Scoliosis: Which Model Fits Best?

Patients will often inquire about the magnitude of height gain after scoliosis surgery. Several published models have attempted to predict height gain using preoperative variables. Many of these models reported good internal validity but have not been validated against an external cohort. We attempted to test the validity of 5 published models against an external cohort from our institution. Models included were Hwang, Van Popta, Spencer, Watanabe, and Sarlak models. We retrospectively queried our institution's records from 2006 to 2019 for patients with adolescent idiopathic scoliosis treated with posterior spinal fusion. We recorded preoperative and postoperative variables including clinical height measurements. We also performed radiographic measurements on preoperative and postoperative radiographic studies. We then tested the ability of the models to predict height gain by evaluating Pearson correlation coefficient, root mean square error, Akaike Information Criterion for each model. A total of 387 patients were included. Mean clinical height gain was 3.1 (±1.7) cm.All models demonstrated a moderate positive Pearson correlation coefficient, except the Hwang model, which demonstrated a weak correlation. The Spencer model was the only model with acceptable root mean square error (≤0.5) and was also the best fitting with the lowest Akaike Information Criterion (-308). The mean differences in height gain predictions between all models except the Hwang model was ≤1cm. Four of the 5 models demonstrated moderate correlation and had good external validity compared with their development cohorts. Although the Spencer model was the best fitting, the clinical significance of the difference in height predictions compared with other models was low. The Watanabe model was the second best fitting and had the simplest formula, making it the most convenient to use in a clinical setting. We offer a simplified equation to use in a preoperative clinical setting based on this data-ΔHeight (mm)=0.77*(preoperative coronal angle-postoperative coronal angle). Not Applicable.

Simultaneous Implant Placement and Sinus Lift Using Leukocyte-Platelet Rich Fibrin: A Retrospective 40-Month Study.

The aim of this study was to report the 40-month clinical radiographical outcomes of maxillary sinus floor augmentation using leukocyte-platelet rich fibrin (L-PRF) as a single graft in combination with immediately placed implants. Twenty partially edentulous individuals with missing teeth in the region associated to maxillary sinus were included in this retrospective study. A lateral sinus floor elevation was performed considering a complete wear of the bone wall of the maxillary sinus and immediately placing the implant and filled the maxillary sinus with L-PRF clots as a single graft. After 5 months, all the implants received single screwed implant-supported prostheses. Subsequent evaluation was every 4 months assessing the success rate and biological complications. Two maxillary sinus membrane were perforated and covered with L-PRF clots. The mean bone height gain was 62.6%, observing a 100% of success and that in all the cases achieved at least the implant height. In conclusion, the use of platelet-rich fibrin clot as a single graft biomaterial during the maxillary sinus lift procedure combined with immediate implant placement may be a reliable clinical alternative, even to repair the sinus membrane.

Transcrestal sinus lift with simultaneous implant placement using osseodensification in posterior maxilla with residual bone height of 4-6 mm

Objective: The aim of this study was to evaluate the transcrestal sinus lift using Osseodensification techniquewith simultaneous implant placement. Material and Methods: In this case series 7 patients who neededimplant placement in the atrophic posterior maxilla were enrolled. In all the cases the residual bone heightbetween the sinus floor and the alveolar crest was 4-6 mm. Transcrestal sinus lift was performed usingOsseodensification with simultaneous implant placement. Cone-beam computed tomography (CBCT) wereobtained immediately postoperative and 6 months after operation. Implant stability using Osstell® wereassessed at the time of implant placement and implant exposure (6 months). Results: The results showedthat the mean bone height gain was 5.33±0.83mm at 6 months postoperatively. Mean bone density valuewas 818.43±109.63 HU. Mean ISQ value was 80.00±3.11 at 6 months postoperatively. The duration ofsurgical procedure (minutes) ranged between 25-38 minutes with an average of 30.86±4.10 minutes.Conclusion: The crestal maxillary sinus floor elevation using Osseodensification technique with simultaneousimplant placement provide superior results regarding bone density and implant stability and less durationof surgical procedure. KEYWORDSSinus floor augmentation; Bone substitutes; Alveolar bone loss; Osteotomy; Dental implantation; Cone-beamcomputed tomography.

Alveolar ridge augmentation with the Bone Into Bone technique: a histological and histomorphometric analysis

Aim Barriers made of cortical bone of heterologous origin are now used as a possible substitute of non-resorbable membranes and bone blocks for the regeneration of bone defects. This report analyzes the efficacy of these barriers, when they are inserted in a surgical slot, vestibular to the defect, using the new Bone into Bone (BiB) technique. Methods A group of 20 patients were treated with the BiB technique, and 32 implants were placed. Bone samples were collected with trephine burs 8 months after surgery and submitted to histological and histomorphometric analysis. The linear horizontal and vertical changes between pre-operative and post-operative radiographs were measured on the CT Scan. Results A mean width gain of 2.36 ± 0. 0.69 mm and a mean height gain of 3.13 ± 0.90 mm was recorded. The biomaterial was almost completely resorbed, and it accounted for 7.39% ± 7.70 of the samples. Conclusion Comparing the current results with those of other investigations, the BiB technique is an efficient alternative to other regenerative approaches, as it provides several advantages, both in terms of reduced morbidity and ease of the procedure. More reports are needed to evaluate the stability of the regenerated bone and to directly compare this technique to other, more commonly used, regenerative procedures.

Real-World Treatment Patterns and Outcomes of Growth Hormone Treatment Among Children in Israel Over the Past Decade (2004-2015).

Objective: To assess a decade of growth hormone (GH) treatment patterns and outcomes in a real-world setting in Israel using a state-of-the-art computerized database.Methods: This large retrospective database study included 2,379 children initiating GH treatment in Maccabi Healthcare Services (between January 2004 and December 2014). Good adherence with therapy (proportion of days covered >80%) was assessed during follow-up.Results: At GH treatment initiation: 62.1% were boys; height standard deviation score (SDS) was −2.36 ± 0.65 (mean ± SD); age was 9.8 ± 3.1 years; and time from short stature diagnosis to first GH purchase was 4.8 ± 3.3 years. Mean treatment period was 3.5 ± 0.95 years; 79.4% of children were treated for more than 3 years. The two main indications for GH therapy were idiopathic short stature (ISS) (n = 1,615, 67.9%) and GH deficiency (GHD) (n = 611, 25.7%). Children in the highest socio-economic-status (SES) tertile comprised 61.3% of ISS and 59.7% of GHD. After 3 years, mean height gain SDS was 1.09 ± 0.91 for GHD and 0.96 ± 0.57 for ISS (p = 0.0004). Adult height (age 15 for girls and 17 for boys) was recorded for 624 patients (26.2%) with better outcomes for GHD than ISS (−1.0±0.82 vs. −1.28±0.93, respectively; p = 0.0002). Good adherence was achieved in 78.2% of the cohort during the first year and declined thereafter to 68.1% during the third year of the treatment.Conclusions: Children who initiate GH therapy are predominantly male, belong mainly to the upper SES, commence treatment a long period after initial recognition of short stature, and have suboptimal adherence. Appropriate referral, diagnosis, and follow-up care may result in better treatment outcomes with GH therapy.

Height Gain Prediction in Adolescent Idiopathic Scoliosis Based on Preoperative Parameters.

The purpose of the study was to identify preoperative parameters which are associated with height gain after corrective surgery for adolescent idiopathic scoliosis (AIS) and their use to preoperatively quantify the potential for height gain after AIS correction. Our study included 87 consecutive patients with AIS who underwent posterior fusion. Patients' height was measured the day before surgery and before their discharge. Demographic and radiologic variables were analyzed for predictability of height gain. The mean height gain was 3.85 cm. We have found a statistically significant correlation between height gain and the following measures: preoperative thoracic curve, preoperative thoracolumbar curve, preoperative thoracic kyphosis, flexibility of the main thoracic and thoracolumbar curves, and number of fused levels (all P<0.05). Patients with Lenke type 1 and 2 had statistically less height gain compared with patients with Lenke type 3, 4, 6. Most of the scoliosis patients with Lenke type 1 and 2 will gain up to 3 cm after surgery while most of the patients with Lenke type 3, 4, 6 will gain more than 3 cm. Most patients with Lenke type 3, 4, 6 with a major curve of less than 60 degrees will gain up to 4 cm, while most of those with a major curve of more than 60 degrees will gain more than 4 cm. Patient with a positive thoracic sagittal modifier tend to have more height gain after surgery.

Assessment of maxillary sinus lifting procedure in the presence of chronic sinusitis, a retrospective comparative study

IntroductionChronic sinusitis can be considered a relative contraindication for sinus lifting procedure. However, its specific effects on bone height, infection and healing have not been as well investigated as its incidence as a post-operative complication. MethodsA retrospective comparative investigation was executed to evaluate the impact of chronic sinusitis on sinus lifting procedures regarding bone height, infection, and healing scores. Pre-operative and 6-month postoperative records (CBCT or CT and panoramic radiographs) of 40 patients who underwent sinus lifting procedure with graft and implant placement were split into two sets of 20 patients each; Group A is comprised of a patient with healthy sinus, whereas Group B includes patients with chronic sinusitis (identified as the presence of thickening of Schniederian membrane ≥ 2 mm, mucosal cyst, polyp or fluid level). Records of both groups were assessed for the difference in bone height of alveolar ridge between pre-operative radiograph and after six months postoperatively, and clinical notifications at the postoperative follow-up to report the healing and infection scores. ResultsStatistically, there was non-significant difference in mean bone height gain (p-value > 0.05) in comparison to control group mean bone height (8.84 ± 0.93). Also, there was non-significant variation in mean healing and infection scores. ConclusionAccording to the available data, chronic sinusitis presenting as a thickening in the Schneiderian membrane has no significant effect on postoperative bone height, healing, or infection score in patients undergoing sinus augmentation with simultaneous implant placement. Further research is needed to better evaluate the effect of chronic sinusitis and its current status as a relative contraindication for sinus lifting procedure.

Switch Data From the Open-Label Extension of the Pivotal Phase 3 Study of Once Weekly Somatrogon Compared to Daily Somatropin in Pediatric Patients With Growth Hormone Deficiency (pGHD)

Abstract Objectives: Somatrogon (hGH-CTP) is a long acting recombinant human growth hormone, consisting of the amino acid sequence of hGH and three copies of the carboxy-terminal peptide (CTP) of human chorionic gonadotropin (hCG) being developed as a once weekly treatment for children with pGHD. This report summarizes data from the first year of the optional open-label extension (OLE) of the pivotal phase 3 global trial (ClinicalTrials. gov: NCT02968004), comparing the efficacy and safety of children switched from Genotropin (rhGH; somatropin) to somatrogon (Geno/Soma) and children maintained on somatrogon (Soma/Soma). Methods: During the main study, 224 children were randomized to receive either once weekly somatrogon (0.66 mg/kg, n=109) or once daily Genotropin (0.24 mg/kg/wk, n=115) for 12 months. Of these, 222 completed the 12-month main study, and 212 chose to enter the OLE study. By Sept 30, 2020, 161 children (including 76 Geno/Soma) had complete auxological data at month 12 of the OLE. Results: At the end of the main study, mean height velocity and gain in height SDS for the somatrogon cohort were 10.10 cm/year and 0.92; for the Genotropin cohort these were 9.78 cm/year and 0.87. Baseline values for the OLE (Soma/Soma group and Geno/Soma group, respectively): height SDS was -1.95 and -1.84, BMI was 17.03 and 15.48 kg/m2 while bone age was 6.54 and 6.40 years. At month 12 (of the OLE), the mean height velocity and the change in height SDS was 8.04 cm/year and 0.41 (Soma/Soma group) and 8.21 cm/year and 0.47 (Geno/Soma group); BMI was 18.07 and 17.49 kg/m2 and bone age was 8.48 and 8.41 years. IGF-1 SDS values were 1.15, and 1.28, while the IGFBP-3 SDS were 0.29 and 0.42, respectively. Dose reductions were required in 16.3% and 20.4% of patients due to IGF-1 SDS &amp;gt;2. Pubertal status changed from Tanner 1 (at OLE baseline) for 13.6% of Soma/Soma patients and 14.6% of Geno/Soma patients. Mean glucose, HbA1c, thyroid function (free T4 and TSH) and cholesterol (total, LDL and HDL) values remained similar to baseline in both groups across the 12 months OLE. The majority of adverse events in both cohorts were mild to moderate (Soma/Soma 94.2%, Geno/Soma 93.5%) and there were no clinically concerning safety observations. During the first 12 months of the OLE six patients discontinued in the Geno/Soma group due to AEs vs zero in the Soma/Soma group. Conclusions: Height velocities and change in height SDS in the OLE were similar between the Geno/Soma and Soma/Soma cohorts. The main phase of the global pivotal phase 3 trial demonstrated that somatrogon (hGH-CTP) given once weekly is non-inferior to Genotropin (hGH) while the OLE demonstrated that catch-up growth continued into the second year of treatment, with ‘switch’ from Genotropin to somatrogon non-inferior to somatrogon given for two years. Metabolic (glycemic, lipid and thyroid) parameters were similar between groups and not meaningfully different from the main study.

Growth and metabolic effects of long-term recombinant human growth hormone (rhGH) treatment in short children born small for gestational age: GH-RAST study.

Objectives To study the efficacy and influence on metabolism of recombinant human growth hormone (rhGH) treatment in short children born small for gestational age (SGA). Methods Retrospective, observational, multicenter study in 305 short children born SGA, treated with rhGH during a mean±SD of 5.03±1.73yearsat a mean±SD dose of 37±8μg/kg/day. Auxological and metabolic assessment including glucose and lipids profile were collected. Results Mean±SD age at the start of treatment was 7.11±2.78 years. Height and weight improved significantly until the end of treatment from mean-2.72 (CI95%:-2.81 to -2.63) standard deviation score (SDS) to-1.16 (CI95%:-1.44 to -0.88) SDS and from-1.62 (CI95%:-1.69 to -1.55) SDS to-0.94 (CI95%:-1.14 to -0.74) SDS respectively. Mean height gain was 1.27 (CI95%: 0.99-1.54) SDS. Prepubertal patients showed higher height gain than pubertal children (mean [CI95%]=1.44 [CI95%: 1.14-1.74] vs. 0.73 [CI95%: 0.22-1.24], p=0.02). Height gain SDS during treatment negatively correlated with chronological age (CA) and bone age (BA) delay and positively correlated with duration of treatment, height gain during first year of treatment, years on prepubertal treatment and height SDS from target height (TH). Glucose, insulin, and triglycerides increased significantly but remained within the normal range. Total and LDL-cholesterol decreased significantly, and HDL-cholesterol remained unchanged. Conclusions rhGH treatment in short SGA children effectively normalized height in most of the patients and showed a safe metabolic profile. Children who benefit the most are those with greater height SDS distance from TH, BA delay, longer duration of treatment and prepubertal treatment initiation.

Differences in Response to Recombinant Growth Hormone Therapy on Height Gain in Patients with Idiopathic Short Stature Vs. Patients with Growth Hormone Deficiency.

ObjectiveThe use of recombinant human growth hormone (rhGH) in patients with idiopathic short stature (ISS) has been an area of concern since some studies reported less desired effects of the drug in this group of patients as compared to patients with growth hormone deficiency (GHD). In addition, there were no studies addressing the effects of rhGH in Saudi children. Therefore, we conducted a retrospective study to observe the effects one year of treatment with rhGH on the mean height gain in patients with ISS and GHD.MethodsThis retrospective study took place at King Abdulaziz Medical City in Jeddah. The study subjects included two groups of patients (GHD vs ISS). Patients' files were reviewed from January 2000 to January 2018 using the following parameters: chronological age, bone age, height, weight, body mass index (BMI), insulin-like growth factor (IGF-1), growth hormone stimulation test, and growth velocity (GV). After one year of treatment, the height, weight, and BMI of the study subjects were monitored and assessed.ResultsThe total number of patients was 55, 36 of which were diagnosed with GHD while 19 were diagnosed with ISS. The mean age of patients with GHD and ISS were 10.7±2.38 and 10.91±2.74 years, respectively. Both groups showed a significant increase in height. The initial height for patients with GHD was 125.26±12.27 cm, and they achieved a mean height of 134.231±12.88 cm after one year of treatment. For the other group, the initial height for ISS patients was 125.51±10.94 cm, and they achieved a mean height of 134.04±10.90 cm after one-year therapy. However, after the treatment, there was no significant difference in the height gain between GHD and ISS patients (134.231±12.88, 134.04±10.90, respectively, P=0.437).ConclusionThe short-term use of rhGH has a potent and similar effect on increasing the height of both patients diagnosed with ISS as well as GHD.

Maxillary sinus floor elevation using hydroxyapatite nano particles vs tenting technique with simultaneous implant placement: A randomized clinical trial.

The present study was conducted to evaluate the amount of bone height gain, density values, and implant stability after maxillary sinus floor elevation using graftless tenting technique or the use of Hydroxyapatite Nanoparticles bone substitute for augmentation with simultaneous implant placement. A total of 20 sinuses with a residual alveolar bone height ranging from 4-6 mm were divided into two groups and underwent sinus augmentation using nano hydroxyapatite bone substitute material and the graftless tenting technique with simultaneous implant placement. Computed tomography CT scans and ISQ measurements were conducted to evaluate bone quality, quantity, and implant stability. Radiographic analysis revealed that the mean bone height gain of the nano group was (7.0 ± 0.8 mm) compared to (5.0 ± 1.5 mm) in the tent group, which was statistically significant (P = .002) being higher in the nano group. The mean bone density value of the nano group was (548 ± 25 HU) compared to (420 ± 23 HU) in the tent group, which was statistically significant (P < .001) being higher in the nano group. The mean ISQ value after 6 months in the nano group was (78 ± 5) compared to (77 ± 5) in the tent group, which was statistically nonsignificant (P = .901). Nano hydroxyapatite bone graft offered superior results in terms of the bone height gain and the relative bone density as compared to graftless tenting technique. However, both techniques showed accepted results regarding implant stability.

SAT-281 Relationship between Socioeconomic Status, Adherence and Outcomes to Growth Hormone Treatment in Children: Real-World Treatment Patterns in Israel

Background: The goals of growth hormone treatment (GHT) during childhood and adolescence are to normalize height velocity and attain a final adult height within the normal range. Despite decades of use, little data is available on GHT patterns and outcomes in a real-life environment. Maccabi Health Services (MHS) is Israel's second biggest health maintenance organization and the database includes up to 20 years of data on 2 million members, offering a unique opportunity to follow real-life GHT children's demographics, clinical data and adherence to therapy. Objective: To assess a decade of GHT patterns and outcomes in a real-world setting via the MHS database. Methods: This was a retrospective cohort database study of all children initiating GHT in MHS (January 2004-December 2014) who met uniform criteria for diagnosis and initiation of therapy. Age, sex, socioeconomic status (SES) and auxologic parameters were recorded at initiation of therapy, and height gain standard deviation score (ΔHtSDS) was calculated during the study period. Adherence was evaluated using proportion of days covered (PDC). Results: 3325 children initiated GHT of whom 2379 were included in the study cohort (62.1% males). The two main indications observed were Idiopathic Short Stature (ISS; n=1615, 67.9%) and Growth Hormone Deficiency (GHD; n=611, 25.7%). Children belonging to the upper third of SES comprised 61.3% of ISS and 59.7% of GHD patients. At initiation of GHT, mean height-SDS was -2.36±0.65 (-2.36±0.6 for GHD and -2.30±0.67 for ISS, p=0.0417); mean age was 9.8±3.1 years (9.42±3.42 for GHD and 10.12±2.9 for ISS, p≤0.0001); time from first diagnosis of short stature (as recorded in the Electronic Medical Record) to first GH purchase was 4.8±3.3 years (4.4±3.1 for GHD and 5.0±3.3 for ISS, p=0.0001). Mean treatment period was 3.5±0.95 years (3.6±1.6 for GHD and 3.4±1.9 for ISS, p=0.017), with 79.4% of patients treated for more than 3 years. The overall mean height gain (ΔHtSDS) was 1.35 and 1.37 for GHD and ISS respectively, and was mainly achieved in the first three years. Final height (at age 15 for girls and 17 for boys) was recorded for 624 patients (26.2%) with GHD patients achieving better outcomes than ISS (-1.0±0.82 vs -1.28±0.93 respectively, p=0.0002). Good adherence (PDC >80%) was achieved in 78.2% of the cohort during the first year, 57.6% in the second, and 68.1% in the third. GHD patients had better adherence than ISS (67.3% vs 58.7%). Conclusions: This large real-life study of treatment patterns in Israel revealed that children initiate GHT a long period after initial recognition of short stature, belong mainly to the upper SES, and have suboptimal adherence from the second year of therapy. This was most pronounced in the ISS group. Over-representation of the upper SES among those receiving GHT reflects treatment bias. Appropriate referral, diagnosis and follow up care may result in better treatment outcomes with GHT.

Changes in Spinal Height After Manual Axial Traction or Side Lying: A Clinical Measure of Intervertebral Disc Hydration Using Stadiometry

ObjectivesThe purpose of this study was to determine the immediate effects of a manual therapy technique consisting of axial traction compared with side lying on increased spine height after sustained loading. MethodsTwenty-one asymptomatic participants were included. Participants either received manual therapy technique consisting of manual axial traction force for 2 consecutive rounds of 3 minutes or sustained side lying for 10 minutes. Spine height was measured using a commercially available stadiometer. Spinal height change was determined from measurements taken after loaded walking and measurements taken after manual therapy. A paired t test was performed to determine if a manual therapy technique consisting of axial traction increased spinal height after a period of spinal loading. ResultsA significant increase in height was found after both manual therapy technique and sustained side lying (P < .0001). The mean height gain was 8.60 mm using 3-dimensional axial separation. ConclusionThis study is an initial attempt at evaluating the biomechanical effects of manual therapy technique consisting of axial traction. Both manual axial traction force and sustained side-lying position were equally effective for short-term change in spine height after a loaded walking protocol among healthy asymptomatic individuals. This study protocol may help to inform future studies that evaluate spine height after loading.