Ricerc@Sapienza

This is a phase IV, randomized, prospective open label study designed to evaluate the effect of two different amounts of vitamin D3 supplementation (daily 800 IU and daily 2000 IU) vs no supplementation on skeletal and non-skeletal manifestations of PHPT in postmenopausal women. Two groups of postmenopausal women with PHPT will be recruited: a) asymptomatic PHPT patients (subjects not fulfilling the surgical criteria); b) symptomatic PHPT patients (surgery group).
The primary endpoint is to evaluate the effect of normal and/or high vitamin D3 supplementation vs no supplementation on the skeletal complications of PHPT. Bone mineral density at the lumbar spine, hip and distal one-third radius will be assessed. The secondary endpoint is to evaluate the effect of the supplementation on other skeletal parameters (trabecular bone score, fractures); number of falls; creatinine clearance and urinary calcium excretion, lipid and glucose metabolism (total cholesterol, triglycerides, HDL cholesterol, LDL cholesterol, RPC and total homocysteinemia, APO B, APO A; glucose-tolerance test in non-diabetic and serum glucose and insulin measured at baseline and at 120 minutes in diabetic patients; HOMA-IR index); cardiac and vascular involvement (diastolic dysfunction, left ventricular hypertrophy, cardiac calcium deposits in the myocardium, aortic and mitral valve calcification + carotid intima-media thickness + carotid plaque + percent of carotid stenosis). Postmenopausal women with PHPT aged 45-80 years will be studied.
The study will provide novel information on relevant clinical outcomes in patients with PHPT and the results will clarify whether vitamin D supplementation could influence the natural history of the disease and/or the recovery of the complications after surgery. Few and inconsistent data are available in PHPT in terms of reversibility of the non-classical complications after surgery and/or the possible role of vitamin D on these outcomes.