Primary outcomeMean· 24 weeks from baseline
% Change From Baseline BMD in L1-L4 Axial Lumbar Spine at Week 24
| Group | Value (percentage of change) | Spread |
|---|---|---|
| Forsteo (Teriparatide) | 5.07 | 3.543 |
| PTH Analog Tablets | 2.21 | 2.503 |
| Placebo | -0.17 | 2.739 |
Trial · Interventional
CompletedPhase 2Results postedRegistry dataPharmacodynamics, Pharmacokinetics, Safety and Tolerability of PTH Analog Tablets in Postmenopausal Women
NCTNCT01321723 (opens ClinicalTrials.gov in a new tab)Other idUGL-OR1001
Overview
- Status
- Completed
- Phase
- Phase 2
- Enrollment
- 97 participants (actual)
- Sponsor
- Unigene Laboratories Inc. · Industry
- Design
- Randomized · Quadruple masking
- Countries
2 countries
Denmark, Estonia
- Start
- Feb 2011
- Primary completion
- Oct 2011
- Completion
- Oct 2011
- First posted
- 23 Mar 2011 (estimated)
- Last update posted
- 1 Mar 2013 (estimated)
- Conditions
- Postmenopausal Osteoporosis
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
20112012
- Ph 2
Pharmacodynamics, Pharmacokinetics, Safety and Tolerability of PTH Analog Tablets in Postmenopausal Women
NCT01321723Feb 2011 to Oct 2011
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- PTH analogDrug
- PlaceboDrug
- Forsteo (Teriparatide)Drug
Arms3
Experimental
PTH analog tablet
PTH(1-31) 5 mg tablet, once daily
Placebo comparator
Placebo
Placebo matching tablet, once daily
Active comparator
Forsteo
Forsteo (teriparatide) 20 mcg SC Injection, once daily
Primary outcomes1
Outcomes the sponsor listed as primary.
% Change From Baseline BMD in L1-L4 Axial Lumbar Spine at Week 24
Time frame · 24 weeks from baseline
Secondary outcomes(3)
% Change From Baseline in Bone Resorption Marker (CTx-1) at Week 24
Time frame · 24 weeks from baseline
Registry description
Serum collagen type I (CTx-1) fragments generated during osteoclastic bone turnover are biomarkers for bone resorption. β-CrossLaps electrochemiluminescent sandwich immunoassay was used.
Systemic Absorption of PTH at Week 24
Time frame · 24 weeks
Registry description
AUC: (PTH analog tablets timepoints - baseline to 5.75 hours) (Forsteo injection timepoints - baseline to 2 hours)
% Change From Baseline in Bone Formation Marker (P1NP) at Week 24
Time frame · 24 weeks from baseline
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Secondary and other outcome results(4)
Post hoc outcomeNumber· 24 weeks
Number of Participants With AEs as a Measure of Safety and Tolerability
| Group | Value (participants) |
|---|---|
| Forsteo (Teriparatide) | 23 |
| PTH Analog Tablets | 30 |
| Placebo | 21 |
Secondary outcomeMean· 24 weeks from baseline
% Change From Baseline in Bone Resorption Marker (CTx-1) at Week 24
| Group | Value (percentage of change) | Spread |
|---|---|---|
| Forsteo (Teriparatide) | 113.32 | 102.932 |
| PTH Analog Tablets | 12.72 | 36.547 |
| Placebo | 15.13 | 23.940 |
Secondary outcomeMean· 24 weeks
Systemic Absorption of PTH at Week 24
| Group | Value (pg* hr/mL) | Spread |
|---|---|---|
| Forsteo (Teriparatide) | 152 | 65.7 |
| PTH Analog Tablets | 165 | 180 |
Secondary outcomeMean· 24 weeks from baseline
% Change From Baseline in Bone Formation Marker (P1NP) at Week 24
| Group | Value (percentage of change) | Spread |
|---|---|---|
| Forsteo (Teriparatide) | 210.07 | 202.613 |
| PTH Analog Tablets | 12.05 | 37.055 |
| Placebo | -1.75 | 27.459 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Forsteo (Teriparatide)Teriparatide : 20 mcg SC Injection, once daily | – | 1 / 32 | 23 / 32 |
| PTH Analog TabletsPTH analog : 5 mg tablets, once daily | – | 2 / 33 | 30 / 33 |
| PlaceboPlacebo : matching tablets, once daily | – | 2 / 32 | 21 / 32 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Other registry references
References listed at the registry that are not in PepBank. They link to PubMed.
- DerivedSturmer A, Mehta N, Giacchi J, Cagatay T, Tavakkol R, Mitta S, Fitzpatrick L, Wald J, Trang J, Stern W. Pharmacokinetics of oral recombinant human parathyroid hormone [rhPTH(1-31)NH(2)] in postmenopausal women with osteoporosis. Clin Pharmacokinet. 2013 Nov;52(11):995-1004. doi: 10.1007/s40262-013-0083-4. PMID 23719683
Eligibility
Who could join, as posted.
- Sex
- Female
- Age
- from 45 Years up to 80 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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
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