PBAC's latest decision on Alendronate sodium, tablet: Recommended with restriction (2006). Considered for Initial treatment as the sole PBS-subsidised anti-resorptive agent for osteoporosis in patients aged 70 years of age or older and with a BMD T-score of -3.0 or less; Initial treatment as the sole PBS-subsidised anti-resorptive agent for established osteoporosis in patients with fracture due to minimal trauma.
PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
$75k/QALY
Range: $15k/QALY–$75k/QALY
Submissions
1
first 2006
Submissions
1
2006 → 2006
Eligible population
patients aged 70 years of age or older and with a BMD T-score of -3.0 or less; patients with fracture due to minimal trauma
Therapy area
Endocrinology
Line of therapy
First-line
Evidence base
RCT
Primary endpoint
OS | PFS | DFS | ORR | QoL | Surrogate
Key trials
FIT (Fracture Intervention Trial)
Comparator
placebo or 'watchful waiting' (patient monitoring and standard management with calcium and vitamin D)