Postmenopausal OsteoporosisPhase 2NCT01321723
Pharmacodynamics, Pharmacokinetics, Safety and Tolerability of PTH Analog Tablets in Postmenopausal Women
A Phase 2 study testing PTH analog and Forsteo (Teriparatide) in people with Postmenopausal Osteoporosis, run by Unigene Laboratories Inc. at 4 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 80 years, women only
- Conditions the study is for
- Postmenopausal Osteoporosis
- What is being tested?
- PTH analog and Forsteo (Teriparatide)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 97 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Feb 2011to Oct 2011
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Healthy postmenopausal women (45-80 years old) with a diagnosis of osteoporosis
Who cannot join
- 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
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
About this study
Official title: 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
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.
Read the detailed description
The choice of a 24-week treatment period was based on published studies of PTH which demonstrate its potential to produce a statistically significant increase in BMD in patients with postmenopausal osteoporosis within that observation period.
- Conditions
- Postmenopausal Osteoporosis
- Being tested
- PTH analog, Placebo, Forsteo (Teriparatide)
- Keywords
- Osteoporosis, Bone Diseases, Metabolic, Bone Diseases, Bone Density Conservation Agents
- Medical subject headings
- Osteoporosis, Postmenopausal, Osteoporosis, Bone Diseases, Metabolic, Bone Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PTH analogDrug
Also called PTH(1-31)
A recombinant 1-31 amino acid fragment of PTH.
PlaceboDrug
Forsteo (Teriparatide)Drug
Also called Forteo (US)
A recombinant 1-34 amino acid fragment of PTH.
| Study group | Role | What they receive |
|---|---|---|
| PTH analog tablet | Experimental | PTH(1-31) 5 mg tablet, once daily Receives: Drug: PTH analog |
| Placebo | Placebo comparator | Placebo matching tablet, once daily Receives: Drug: Placebo |
| Forsteo | Active comparator | Forsteo (teriparatide) 20 mcg SC Injection, once daily Receives: Drug: Forsteo (Teriparatide) |
What is being measured
The primary outcome is the main question the study is designed to answer.
% Change From Baseline BMD in L1-L4 Axial Lumbar Spine at Week 24
Measured: 24 weeks from baseline
Secondary outcomes (3)
% Change From Baseline in Bone Resorption Marker (CTx-1) at Week 24
Serum collagen type I (CTx-1) fragments generated during osteoclastic bone turnover are biomarkers for bone resorption. β-CrossLaps electrochemiluminescent sandwich immunoassay was used.
Measured: 24 weeks from baseline
Systemic Absorption of PTH at Week 24
AUC: (PTH analog tablets timepoints - baseline to 5.75 hours) (Forsteo injection timepoints - baseline to 2 hours)
Measured: 24 weeks
% Change From Baseline in Bone Formation Marker (P1NP) at Week 24
Measured: 24 weeks from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2011 (estimated)
- Study startFeb 2011
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Postmenopausal OsteoporosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unigene Laboratories Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline
- Responsible party
- Sponsor
- Investigators
- Christence S Teglbjaerg, MD, Principal investigator, CCBRBettina S Nedergaard, MD, Principal investigator, CCBRPeter Alexandersen, MD, Principal investigator, CCBRIvo Valter, MD, Principal investigator, CCBR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01321723
- Sponsor's protocol ID
- UGL-OR1001
- Status last verified
- Jan 2013
- First submitted
- 16 Mar 2011
- Last updated
- 1 Mar 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Henriksen K, Andersen JR, Riis BJ, Mehta N, Tavakkol R, Alexandersen P, Byrjalsen I, Valter I, Nedergaard BS, Teglbjaerg CS, Stern W, Sturmer A, Mitta S, Nino AJ, Fitzpatrick LA, Christiansen C, Karsdal MA. Evaluation of the efficacy, safety and pharmacokinetic profile of oral recombinant human parathyroid hormone [rhPTH(1-31)NH(2)] in postmenopausal women with osteoporosis. Bone. 2013 Mar;53(1):160-6. doi: 10.1016/j.bone.2012.11.045. Epub 2012 Dec 9.
PubMed 23234813Sturmer 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.
PubMed 23719683
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01321723
- Acronym / sponsor ID
- UGL-OR1001
- Conditions
- Postmenopausal Osteoporosis
- Keywords
- Osteoporosis, Bone Diseases, Metabolic, Bone Diseases, Bone Density Conservation Agents
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Unigene Laboratories Inc.Industry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline
- Study start
- Feb 2011
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 23 Mar 2011 (estimated)
- Results
- Posted 21 Feb 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The choice of a 24-week treatment period was based on published studies of PTH which demonstrate its potential to produce a statistically significant increase in BMD in patients with postmenopausal osteoporosis within that observation period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PTH analog tablet | Experimental | Drug: PTH analogPTH(1-31) 5 mg tablet, once daily |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo matching tablet, once daily |
| Forsteo | Active comparator | Drug: Forsteo (Teriparatide)Forsteo (teriparatide) 20 mcg SC Injection, once daily |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy postmenopausal women (45-80 years old) with a diagnosis of osteoporosis
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PTH analogAlso: PTH(1-31)A recombinant 1-31 amino acid fragment of PTH. | Drug | PTH analog tablet |
| Placebo | Drug | Placebo |
| Forsteo (Teriparatide)Also: Forteo (US)A recombinant 1-34 amino acid fragment of PTH. | Drug | Forsteo |
Primary outcome
% Change From Baseline BMD in L1-L4 Axial Lumbar Spine at Week 24
Time frame: 24 weeks from baseline
3 secondary outcomes
% Change From Baseline in Bone Resorption Marker (CTx-1) at Week 24
Time frame: 24 weeks from baseline
Systemic Absorption of PTH at Week 24
Time frame: 24 weeks
% Change From Baseline in Bone Formation Marker (P1NP) at Week 24
Time frame: 24 weeks from baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 23234813Henriksen K, Andersen JR, Riis BJ, Mehta N, Tavakkol R, Alexandersen P, Byrjalsen I, Valter I, Nedergaard BS, Teglbjaerg CS, Stern W, Sturmer A, Mitta S, Nino AJ, Fitzpatrick LA, Christiansen C, Karsdal MA. Evaluation of the efficacy, safety and pharmacokinetic profile of oral recombinant human parathyroid hormone [rhPTH(1-31)NH(2)] in postmenopausal women with osteoporosis. Bone. 2013 Mar;53(1):160-6. doi: 10.1016/j.bone.2012.11.045. Epub 2012 Dec 9.
- Derived from this study: PubMed 23719683Sturmer 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.
Related trials for Postmenopausal Osteoporosis
Active, not recruitingObservational study
The Impact of Osteosarcopenia on Falls, Kinesiophobia, and Quality of Life in Postmenopausal Women
Osteosarcopenia, Sarcopenia
Not yet recruitingPhase 4
Romosozumab and Denosumab Combination Therapy for Osteoporosis
Postmenopausal Osteoporosis
Not yet recruiting
Effects of Sensorimotor Balance Training vs Digitally Augmented Core Stabilization in Women With Osteoporosis
Postmenopausal Osteoporosis
Active, not recruitingPhase 4
Abaloparatide Added to Ongoing Denosumab vs Continued Denosumab Alone
Osteoporosis, Postmenopausal
RecruitingPhase 4
Combined Anabolic Therapy
Osteoporosis, Postmenopausal, Osteoporosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christence S Teglbjaerg, MD principal investigator
CCBR
Bettina S Nedergaard, MD principal investigator
CCBR
Peter Alexandersen, MD principal investigator
CCBR
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PTH analog and Forsteo (Teriparatide) in people with Postmenopausal Osteoporosis, run by Unigene Laboratories Inc. at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Denmark, Estonia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Feb 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
% Change From Baseline BMD in L1-L4 Axial Lumbar Spine at Week 24 (time frame: 24 weeks from baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01321723, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2013.