drugset / Trial / NCT00713258
The Effect of PTH(1-84) or Alendronate on Reduction of Back Pain in Postmenopausal Women With an Osteoporosis Related Vertebral Fracture(s) (FP-005-IM)
RandomizedParallel-groupDouble-blindTreatment
Summary
The primary objective of this trial is to show that PTH(1-84) is superior to alendronate in reducing back pain intensity over a 24-week treatment period in postmenopausal women with an osteoporosis related vertebral fracture(s). Secondly the objectives are to investigate any differences in patient reported outcomes between the two treatment arms over a 24-week treatment period in postmenopausal women with an osteoporosis related vertebral fracture(s).
Timeline
- Start
- 2008-04
- Primary completion
- 2010-05
- Completion
- 2010-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Alendronic Acid | Small molecule | 70 mg | — |
| Comparator | Parathyroid hormone (PTH) (1-84) | Unknown | 100 ug | — |
Indications
No indication recorded.