Efficacy and safety of daily treatment with parathyroid hormone were evaluated in a typical Italian population with severe post-menopausal osteoporosis eligible to anabolic treatment (Nota 79 AIFA). Materials and methods: 204 ambulatory female patients (median age: 72.6±8.3 years; height: 155.3±6.5 cm; weight: 61.1±11.9 Kg) with severe post-menopausal osteoporosis have been enrolled in this study accordingly to summary of product characteristics and Italian reimbursement criteria for osteoporosis drugs (Nota 79 AIFA), between January 2008 and April 2009 (Last Patient Out: October 2010). 146 (71.57%) out of these patients completed the study.6 visits were planned in the study protocol: baseline and after 1, 3, 6, 12 and 18 months of therapy. In a subgroup of patients BMD was also evaluated at baseline and at the end of the study. Moreover, every clinical fracture event was captured. Hypercalcaemia was arbitrarily defined as a serum calcium value ≥10.7 mg/dl. Results: During the study, a significant improvement of median T-score was observed, at lumbar spine (baseline: −2.79±1.31; 18 months: −2.45±1.23, p<0.0001, N=53), at total femur (baseline: −2.40±1.02; 18 months: −2.27±0.96; p=0.0368; N=55) and at femur neck (baseline: −2.64±0.86; 18 months: −2.48±0.90; p=0.0205, N=61). 24 new clinical fractures (in 21 patients) were recorded; 11 out of them were vertebral and 3 femoral. A similar incidence of fractures was reported in previous studies carried out in similar populations. Hypercalcaemia was more frequently detected in the first months of treatment (14.3% at 3rd month) and comparable to that registered in the PATH study with PTH 1–84; hypercalcaemia was considerably reduced in the late treatment phase (4.43% after 12 month, 1.82% after 18 months). Only in one patient the hypercalcaemia determined treatment discontinuation. Conclusions: Data obtained from this study confirm efficacy and safety of parathyroid hormone therapy for severe post-menopausal osteoporosis treatment.
|Numero di pagine||1|
|Stato di pubblicazione||Published - 2012|