Osteoporosis
Conditions
Brief summary
This 2 arm study will assess the efficacy and safety of intravenous Bonviva in patients with osteoporosis experiencing pain after recent vertebral osteoporotic fracture. Patients will be randomized to receive either Bonviva (3mg i.v. bolus injection) or placebo. The anticipated time on study treatment is \<3 months, and the target sample size is 100-500 individuals.
Interventions
DRUGPlacebo
Placebo i.v. single dose
3mg i.v. single dose
Sponsors
Hoffmann-La Roche
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* postmenopausal women or men \>30 years of age; * osteoporosis; * vertebral osteoporotic fracture in past 4 weeks; * fracture-related pain requiring analgesic treatment.
Exclusion criteria
* non-menopausal women; * current treatment with another bisphosphonate; * current treatment with class III analgesics.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Success of Bonviva therapy (>=20% diminution of pain intensity between day 0 and 7, with stabilization or diminution of concomitant analgesics between day 3 and 7). | Day 7 |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of patients with >=50% diminution of pain between day 0 and 7 | Day 7 |
| Pain control | Day 7 and 1 month |
| Analgesic medication | 1 month |
| Hospitalization | 1 month |
| AEs and laboratory parameters | Throughout study |
Countries
France
Outcome results
None listed