Impact of non-weight-dependent low-dose somatropin on bone accrual in childhood-onset GH deficient in the transition: an 18-month randomized controlled trial
Non-weight-based low-dose somatropin withdrawal may limit bone accrual in adolescents with childhood-onset GH deficiency during transition.
Where it sits
this study against the rest of the hgh (somatropin) corpusSummary and findings
This study measured the impact of non-weight-based low-dose somatropin withdrawal on bone accrual in adolescents with childhood-onset GH deficiency over 18 months. A total of 54 adolescents were assessed, with some receiving somatropin and others not. The findings indicated differences in bone mineral density and content between groups.
Abstract
<title>Abstract</title> <p><bold>Objective </bold>Discontinuation of growth hormone therapy (rhGH) upon completion of linear growth may adversely affect bone mineral density (BMD) and bone mineral content (BMC) in adolescents with childhood-onset GH deficiency (CO-GHD) and predispose them to osteoporosis. In the present study, we analyzed the impact of non-weight-based low-dose somatropin withdrawal on bone accrual during this transition among CO-DGH patients who had been treated since childhood. <bold>Methods </bold>Lumbar spine (LS) and whole-body (WB) BMD and BMC were measured at baseline and after 18 months in 54 adolescents (age: 16.8 ±1.6 years). They were retested and reclassified as GH sufficient (GS, n= 28) and GH insufficient. The last group were later randomized to use rhGH (GH+; n= 15) or no treatment (GH-, n= 11) in this single-center open-label study. The average dose of rhGH was 0.5 ± 0.18 mg/day. <bold>Results </bold>When comparing the 3 groups, the GH group had a lower percentage change in LS BMD than the GS group (0.53 % ± 5.9 vs. 4.42 % ± 4.1, respectively, p < 0.04). However, in the analysis of the GH+ and GH- subgroups, the LS BMC percentage change was higher in the GH+ group (11.02% ± 10.12 vs. 2.05 % ± 10.31, respectively, p< 0.04). <bold>Conclusions </bold>Non-weight-based low-dose somatropin withdrawal for 18 months limits bone accrual in LS of CO-DGH in transition. More studies on this therapeutic regimen are necessary to assess the long-term impact on peak bone mass in these younger populations.</p>
Background
This paper addresses the effects of discontinuing growth hormone therapy on bone health in adolescents with childhood-onset GH deficiency. Prior research has suggested that such discontinuation may negatively impact bone mineral density and predispose individuals to osteoporosis. Understanding the implications of somatropin withdrawal during this transitional phase is critical for managing long-term bone health in these patients.
Methods
The study utilized a randomized controlled trial design involving 54 adolescents with a mean age of 16.8 ± 1.6 years. Participants were assessed for lumbar spine and whole-body bone mineral density and content at baseline and after 18 months. The average dose of rhGH administered was 0.5 ± 0.18 mg/day.
Results
The primary endpoint showed that the GH group had a lower percentage change in lumbar spine BMD compared to the GS group, with values of 0.53 % ± 5.9 vs. 4.42 % ± 4.1, respectively, p < 0.04. Additionally, in the GH+ and GH- subgroups, the LS BMC percentage change was significantly higher in the GH+ group at 11.02% ± 10.12 compared to 2.05 % ± 10.31 in the GH- group, p < 0.04.
Interpretation
The findings suggest that low-dose somatropin withdrawal may limit bone accrual in adolescents with childhood-onset GH deficiency, as indicated by the lower BMD changes. While the results are statistically significant, the clinical relevance of the observed effect sizes may be limited due to the small sample size and open-label nature of the study. Further research is needed to evaluate the long-term effects on peak bone mass.
Key findings
- 0.53 % ± 5.9 LS BMD change in GH group vs 4.42 % ± 4.1 in GS group, p < 0.04.
- 11.02% ± 10.12 LS BMC change in GH+ group vs 2.05 % ± 10.31 in GH- group, p < 0.04.
Limitations
- small sample size n=54
- open-label design may introduce bias
- single-center study limits generalizability
- short follow-up duration of 18 months