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)

A 24-week, International, Multi Centre, Randomised, Double-blind, Double-dummy, Parallel Group, Phase IV Clinical Trial Investigating Changes in Back Pain in Postmenopausal Women With an Osteoporosis Related Vertebral Fracture(s) Treated With Either 100 µg PTH(1-84) Daily or 70 mg Alendronate Weekly

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: Nycomed · Industry
• Sex: Female
• Age: 50 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Back Pain

Interventions

Type	Name	Description
DRUG	Parathyroid hormone (PTH) (1-84)	100 µg PTH(1-84) daily
DRUG	Alendronate	70 mg alendronate weekly

Timeline

• Start date: 2008-04-01
• Primary completion: 2010-05-01
• Completion: 2010-09-01
• First posted: 2008-07-11
• Last updated: 2012-05-08
• Results posted: 2011-10-07

Locations

1 site across 1 country: Denmark