At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 407 enrolled
Drug / intervention
Parathyroid Hormone (PTH) +1 moredrug
Likely dose
Parathyroid Hormone (PTH) 100 μgfrom 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.
An Open Label, International, Multi Centre, Parallel Group, Phase III b, Randomised Trial, Investigating Lumbar Spine Bone Mineral Density (BMD) Changes in Postmenopausal Women With Primary Osteoporosis Initially Treated With 12 Months of Full Length Parathyroid Hormone (PTH 1-84) Followed by 12 Months of Treatment With Risedronate Followed by Either 12 Months Treatment With PTH (1-84) or Risedronate.
In Brief
A Phase 3 clinical trial evaluating Parathyroid Hormone (PTH) and Risedronate for Osteoporosis. Completed, enrolled 407 participants across 1 site.
Detailed Summary
The objective is to show superior efficacy of PTH (1-84) over risedronate in treating osteoporotic women for 12 months after having previously been treated with PTH (1-84) for 12 months followed by 12 months treatment with risedronate.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOsteoporosis
CountriesDenmark
Collaborators--
Timeline
Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJul 2006
First PostedAug 2006
Primary CompletionJan 2011
Study CompletionAug 2011
TodayJul 2026
First PostedAug 17, 2006
Enrollment StartJul 1, 2006
Primary CompletionJan 1, 2011
Study CompletionAug 1, 2011
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 19.9 years ago
Interventions
Parathyroid Hormone (PTH)drug
Self-administered (100 μg in a volume of 71.4 μL) daily as a subcutaneous injection in the abdomen using the Preotact pen.
Risedronatedrug
Orally once weekly as one 35 mg tablet.