Table 3.
Baseline clinical and biochemical features as well as total (ALP) and bone alkaline phosphatase (BAP) nadir levels after zoledronate treatment in patients with Paget’s disease of bone (PDB) needing retreatment (R-PDB) and achieving a good disease control with a single infusion (C-PDB)
| R-PDB (n = 9) | C-PDB (n = 38) | Ref. range | |
|---|---|---|---|
| Sex (M / F) | 5 / 4 | 19 / 19 | |
| Age (years) | 66.1 ± 11.2a | 74.0 ± 7.7 | |
| BMI (kg/m2) | 30.9 ± 9.3 | 26.5 ± 4.3 | 18.5–24.9 |
| Time since PDB diagnosis (years) | 11.8 ± 12.4 | 5.6 ± 7.1 | |
| Poliostotic disease | 7 (78)a | 15 (40) | |
| Pelvis pagetic localization | 7 (78) | 31 (82) | |
| Spine pagetic localization | 7 (78)a | 13 (34) | |
| Femur pagetic localization | 2 (22) | 7 (18) | |
| Skull pagetic localization | 1 (11) | 6 (16) | |
| Pagetic fractures | 3 (33)a | 2 (5) | |
| N° of pts treated with Zol (4/5 mg) | 2/7 | 9 / 29 | |
| ALP (UI/l) | 913.6 ± 685.8a | 350.5 ± 650.4 | 50–150 |
| BAP (mcg/l) | 96.5 ± 24.8a | 44.9 ± 27.7 | < 21 |
| Serum total calcium (mmol/l) | 2.3 ± 0.1 | 2.3 ± 0.2 | 2.2–2.6 |
| Serum ionized calcium (mmol/l) | 1.1 ± 0.1 | 1.2 ± 0.1 | 1.1–1.3 |
| Urinary calcium (mmol/die) | 2.4 ± 1.5 | 2.8 ± 1.5 | 2.5–7.5 |
| Parathormone (pmol/l) | 5.84 ± 3.60 | 4.75 ± 2.92 | 1.05–6.90 |
| 25(OH) vitamin D (nmol/l) | 35.2 ± 15.0 | 57.2 ± 25.7 | 75–125 |
| Serum creatinine (µmol/l) | 69.4 ± 18.2 | 76.8 ± 15.5 | 44–106 |
| Creatinine clearance (ml/s) | 1.5 ± 0.3 | 1.3 ± 0.4 | 1.2–2.0 |
| Nadir of ALP (UI/l) | 117.0 ± 55.2a | 66.6 ± 20.3 | 50–150 |
| Nadir of BAP (mcg/l) | 24.7 ± 24.1a | 8.1 ± 4.1 | < 21 |
Data are presented as mean ± standard deviation or n (percentage). Statistical analysis is performed by Mann–Whitney test and Pearson’s Χ2
BMI body mass index, ALP alkaline phosphatase, BAP bone alkaline phosphatase
ap < 0.05 vs C-PDB