CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 82 enrolled
Drug / intervention
Full Length Parathyroid Hormone, PTH(1-84) +1 moredrug
Likely dose
Strontium Ranelate 2 gfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00479037
NCT00479037Phase 4Completed

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

Nycomed·interventional·Posted May 25, 2007·Updated May 8, 2012

In Brief

A Phase 4 clinical trial evaluating Full Length Parathyroid Hormone, PTH(1-84) and Strontium Ranelate for Osteoporosis. Completed, enrolled 82 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOsteoporosis
CountriesDenmark
Collaborators--

Timeline

Phase 4CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 25, 2007
Enrollment StartApr 1, 2007
Primary CompletionFeb 1, 2009
Study CompletionJul 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 19.1 years ago

Interventions

Full Length Parathyroid Hormone, PTH(1-84)drug

Once daily subcutaneous injection in the abdomen by self administration

Strontium Ranelatedrug

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