At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 97 enrolled
Drug / intervention
PTH analog +2 moredrug
Likely dose
Not stated in 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.
A Double Blind, Randomized, Repeat Dose Parallel Group Study of Recombinant Human Parathyroid Hormone Analog Tablets, or Placebo Tablets, Compared to Open Label Forsteo® in Postmenopausal Women With Osteoporosis
In Brief
A Phase 2 clinical trial evaluating PTH analog, Placebo, and 1 other intervention for Postmenopausal Osteoporosis. Completed, enrolled 97 participants across 4 sites in 2 countries.
Detailed Summary
This study is designed to provide information about the bone anabolic properties and absorption profile of Unigene's PTH Analog when administered as oral tablets over a period of 24 weeks to postmenopausal women with osteoporosis.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPostmenopausal Osteoporosis
CountriesDenmark, Estonia
CollaboratorsGlaxoSmithKline
Timeline
Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartFeb 2011
First PostedMar 2011
Primary CompletionOct 2011
TodayJul 2026
First PostedMar 23, 2011
Enrollment StartFeb 1, 2011
Primary CompletionOct 1, 2011
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 15.3 years ago
Interventions
PTH analogdrug
A recombinant 1-31 amino acid fragment of PTH.
Placebodrug
Forsteo (Teriparatide)drug
A recombinant 1-34 amino acid fragment of PTH.