Table 4.
Fracture Incidence in Postrenal Transplant Patients Between Bisphosphonate and Control Groups.
| Study | Protocol | Baseline fractures | New fracture incidence | Findings | ||
|---|---|---|---|---|---|---|
| Walsh et al28 | Spine radiographs at baseline, 12, 24
months Blinded interpretation using Genant et al42 scale |
N = 23/93 total 12/46 in intervention group (1 axial) 11/47 in control group |
At 12 months | At 24 months | 4.2% (−7.3 to 16.6) difference between groups at
12 months (P = .7) 8.4% (−3.7 to 22.2) between groups at 24 months (P = .3) |
|
| I (n = 46): | 2 | 2 (3.3%/yr) |
||||
| C (n = 47): | 4 | 6 (6.4%/yr) |
||||
| Schwarz et al30 | Not formally assessed as endpoint | Not assessed | Between 6 months and 3 years: I (n = 9): 2 vertebral fractures C (n = 10): 2 vertebral fractures |
No analysis done | ||
| Yamamoto et al36 | Nontraumatic (low energy) fractures Assessed via personal interviews and medical records |
N = 7/24 (4 wrist, 2 rib, 1 leg, 1 cuboidal) |
4 patients with 5 fractures during 3-year
period (2 leg, 1 lumbar spine, 1 hip, 1 humeral) |
New fractures correlated with higher intact PTH levels
(pg/mL) at baseline: Fracture (−) = 116.0 ± 52.6 Fracture (−) = 255.0 ± 3.0 (P < .0001) |
||
| Conley et al38 | Self-reported Counted if occurring between BMD1 and BMD2 (both occurring >1 year posttransplant) |
I: 56/315 C: 16/239 Significantly more patients with fracture in intervention group (P = .0002) |
I: 16 C: 7 (P < .05) Increase in bone density between BMD1 and BMD2 did not prevent late fractures |
Treatment associated with decreased probability of
fracture-free survival (HR = 0.40; 95% CI = 0.29-0.73,
P = .001) No association found between rate of bone loss and fractures, regardless of the bisphosphonate therapy |
||
| Arlen et al41 | Not formally assessed as endpoint | Not assessed | I (n = 25): n = 2 C (n = 24): n = 1 |
All patients who sustained fractures were from high-risk treatment group (BMD lower than mean baseline of control group) | ||
Note. I = intervention; C = control; BMD = bone mineral density; PTH = parathyroid hormone; HR = hazard ratio; CI = confidence interval. White is RCT, Grey shaded region is Observational trials.