NCT00479037

Effect of Full Length Parathyroid Hormone, PTH(1-84) or Strontium Ranelate on Bone Markers in Postmenopausal Women With Primary Osteoporosis (FP-006-IM)

A 24-week, International, Multi Centre, Randomised, Open Label, Parallel Group, Phase IV Clinical Trial Investigating Changes in Bone Formation Markers in Postmenopausal Women With Primary Osteoporosis Treated With Either PTH(1-84) or Strontium Ranelate

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 82 (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 strontium ranelate in bone formation measured as changes in bone formation markers over a treatment period of 24 weeks in postmenopausal women with primary osteoporosis.

Conditions

• Osteoporosis

Interventions

Type	Name	Description
DRUG	Full Length Parathyroid Hormone, PTH(1-84)	Once daily subcutaneous injection in the abdomen by self administration
DRUG	Strontium Ranelate	The daily dose of 2 g (one sachet) strontium ranelate was to be mixed in a glass of water and taken immediately after mixing at bedtime at least 2 hours before or after intake of calcium, any food or drinks, other than water

Timeline

• Start date: 2007-04-01
• Primary completion: 2009-02-01
• Completion: 2009-07-01
• First posted: 2007-05-25
• Last updated: 2012-05-08
• Results posted: 2011-06-28

Locations

1 site across 1 country: Denmark