Osteoporosis
Conditions
Keywords
Bisphosphonate,BMD,Height loss, Hip protectors,HRT,, Osteoporosis
Brief summary
HORIZON-PFT (Pivotal Fracture Trial) will study the effect of zoledronic acid, given once per year, on the treatment of osteoporosis in women past menopause. Hip and vertebral fractures are the most devastating consequences of osteoporosis. HORIZON-PFT is designed to determine the benefits of zoledronic acid in fracture reduction at both the hip and spine.
Interventions
DRUGZoledronic Acid
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
FEMALE
Age
65 Years to 89 Years
Healthy volunteers
No
Inclusion criteria
* Female, 65-89 years old * No history of severe liver, kidney or eye disease
Exclusion criteria
* Current bisphosphonate users such as Aredia® (pamidronate), Didronel® (etidronate), Fosamax® (alendronate), Actonel® (risedronate), Skelid® (tiludronate) * Using hip protectors Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of hip fxs | — |
| Incidence of new vertebral fxs | — |
Secondary
| Measure | Time frame |
|---|---|
| Percent change in hip BMD | — |
| New and/or worsening vertebral fxs | — |
| All clinical fxs | — |
Countries
Germany, United States
Outcome results
None listed