Objective: To verify the effects of bisphosphonates (Bps) in combination with recombinant human growth hormone (rGH) in pediatric osteogenesis imperfecta (OI) patients; we focused on possible improvement of bone mineral density (BMD), projected bone areas, growth velocity and fractures risk. Design: A randomized controlled 1-year clinical trial on 30 pre-pubertal children (M:F=14:16) affected by OI (type I, IV, III) being treated with Neridronate (N). Methods: Following an observational period of 12 months during ongoing N treatment, the patients were randomly divided into two groups: 15 were treated for 12 months with rGH and N (Group Bp+rGH) and 15 continued N alone (Group Bp). We evaluated auxological parameters, number of fractures, bone age (BA), bone metabolic parameters and bone mass measurements (at lumbar spine and radius by DXA). Results: The mean variation in percentage of BMD (Delta%BMD) - at lumbar spine (L2-L4), at distal and ultra distal radius- and the projected area of lumbar spine increased significantly in Group Bp+rGH (p<0.05). Growth velocity was significantly higher during rGH treatment in group Bp+rGH vs group Bp and vs pre-treatment (p< 0.05), with no difference in increase in BA or fracture risk rate. Patients with quantitative collagen synthesis defects had a higher, although not significant, response to rGH in terms of growth velocity and BMD. Conclusions: In OI patients the combined rGH-Bp treatment may give better results than Bp treatment alone, in terms of BMD, lumbar spine projected area and growth velocity, particularly in patients with quantitative defects.
GH in combination with bisphosphonate treatment in osteogenesis imperfecta
ANTONIAZZI, Franco;MONTI, Elena;VENTURI, Giacomo;GATTI, Davide;ZAMBONI, Giorgio;
2010-01-01
Abstract
Objective: To verify the effects of bisphosphonates (Bps) in combination with recombinant human growth hormone (rGH) in pediatric osteogenesis imperfecta (OI) patients; we focused on possible improvement of bone mineral density (BMD), projected bone areas, growth velocity and fractures risk. Design: A randomized controlled 1-year clinical trial on 30 pre-pubertal children (M:F=14:16) affected by OI (type I, IV, III) being treated with Neridronate (N). Methods: Following an observational period of 12 months during ongoing N treatment, the patients were randomly divided into two groups: 15 were treated for 12 months with rGH and N (Group Bp+rGH) and 15 continued N alone (Group Bp). We evaluated auxological parameters, number of fractures, bone age (BA), bone metabolic parameters and bone mass measurements (at lumbar spine and radius by DXA). Results: The mean variation in percentage of BMD (Delta%BMD) - at lumbar spine (L2-L4), at distal and ultra distal radius- and the projected area of lumbar spine increased significantly in Group Bp+rGH (p<0.05). Growth velocity was significantly higher during rGH treatment in group Bp+rGH vs group Bp and vs pre-treatment (p< 0.05), with no difference in increase in BA or fracture risk rate. Patients with quantitative collagen synthesis defects had a higher, although not significant, response to rGH in terms of growth velocity and BMD. Conclusions: In OI patients the combined rGH-Bp treatment may give better results than Bp treatment alone, in terms of BMD, lumbar spine projected area and growth velocity, particularly in patients with quantitative defects.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.