At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 23 enrolled
Drug / intervention
Abaloparatidedrug
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.
An Open-Label, Single-Arm, Multicenter Study to Evaluate the Early Effects of Abaloparatide on Tissue-Based Indices of Bone Formation and Resorption
In Brief
A Phase 3 clinical trial evaluating Abaloparatide for Osteoporosis, Postmenopausal and 8 related conditions. Completed, enrolled 23 participants across 4 sites.
Detailed Summary
The objective of this study is to measure the early effects of abaloparatide on tissue-based bone formation using samples obtained by transiliac crest bone biopsy after quadruple fluorochrome labeling.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOsteoporosis, Postmenopausal, Osteoporosis, Osteoporosis Vertebral, Osteoporosis Risk, Osteoporosis Fracture, Osteoporosis Localized to Spine, Osteoporosis, Age-Related, Osteoporosis Senile, Osteoporosis of Vertebrae
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20192020202120222023202420252026
Enrollment StartSep 2018
First PostedOct 2018
Primary CompletionJul 2020
TodayJul 2026
First PostedOct 18, 2018
Enrollment StartSep 20, 2018
Primary CompletionJul 15, 2020
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 7.7 years ago
Interventions
Abaloparatidedrug
Abaloparatide is a novel, synthetic, 34 amino acid peptide designed to be a potent and selective activator of the PTH/PTH-related protein (PTHrP) type 1 receptor (PTHR1) signaling pathway with 41% homology to PTH\[1-34\] and 76% homology to human PTHrP\[1-34\].