Phase 2
N=97
Pharmacodynamics, Pharmacokinetics, Safety and Tolerability of PTH Analog Tablets in Postmenopausal Women
Postmenopausal Osteoporosis
Bottom Line
View on ClinicalTrials.gov: NCT01321723 ↗Enrolled (actual)
97
Serious AEs
5.1%
Results posted
Feb 2013
Primary outcome: Primary: % Change From Baseline BMD in L1-L4 Axial Lumbar Spine at Week 24 — 5.07; 2.21; -0.17 percentage of change
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- PTH analog (Drug); Placebo (Drug); Forsteo (Teriparatide) (Drug)
- Age
- Adult, Older Adult · 45+ yrs
- Sex
- Female
- Sponsor
- Unigene Laboratories Inc.
- Primary completion
- Oct 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY % Change From Baseline BMD in L1-L4 Axial Lumbar Spine at Week 24 |
5.07; 2.21; -0.17 | — |
| SECONDARY % Change From Baseline in Bone Resorption Marker (CTx-1) at Week 24 |
113.32; 12.72; 15.13 | — |
| SECONDARY Systemic Absorption of PTH at Week 24 |
152; 165 | — |
| SECONDARY % Change From Baseline in Bone Formation Marker (P1NP) at Week 24 |
210.07; 12.05; -1.75 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Healthy postmenopausal women (45-80 years old) with a diagnosis of osteoporosis
Exclusion Criteria
- Use of estrogen or hormone replacement therapy
- Use of bisphosphonates, strontium ranelate or denosumab
- Use of parathyroid analogues or other bone metabolic agents
- Medical conditions which might alter bone metabolism
- Any known clinically significant disease affecting calcium metabolism or history of metabolic disorders including Paget's disease, osteogenesis imperfecta, or osteomalacia
- Impairment of thyroid function
Data sourced from ClinicalTrials.gov (NCT01321723). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.