OsteoporosisPhase 2NCT00535860
Efficacy & Safety of ViaDerm-hPTH(1-34) Compared to Forteo SC in Postmenopausal Women With Osteoporosis
A Phase 2 study testing Teriparatide in people with Osteoporosis, run by TransPharma Medical at 10 sites in 3 countries.
Trial summary
The purpose of this study is to assess the clinical efficacy, safety, and tolerability of ViaDerm-shPTH [1-34] transdermal delivery in comparison to subcutaneous injection of rhPTH[1-34] following 3-month treatment in postmenopausal women with Osteoporosis Read more about this study
- Who is it for?
- Ages 55 to 85 years, women only
- Conditions the study is for
- Osteoporosis
- What is being tested?
- Teriparatide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 10 sitesin 3 countries
- Study dates
- Apr 2008to Mar 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 55 to 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Main Inclusive Criteria:
- Post-menopausal women aged between 55 to 85 years (inclusive)
- Posterior-Anterior lumbar vertebral and/or femoral neck BMD T-score by DXA ≤-2.5 SD.
- Have normal serum PTH, thyroid stimulating hormone (TSH) (only for patients treated with thyroid hormone), and prolactin values.
Main Exclusive Criteria:
- Subjects who have a clinical significant or unstable medical or surgical condition that may preclude safe and complete study participation
- Current diagnoses of disorders known to affect bone metabolism including hyperthyroidism, hyperparathyroidism, osteomalacia, or Paget's disease
- Prior osteoporosis treatment with fluoride or strontium at any time; or any IV treatment with bisphosphonates in the past or oral bisphosphonate for more than 1 month in the past 24 months prior to randomization.
- Any condition or disease that may interfere with the ability to have, or to evaluate a DXA scan
Trial locations and contacts
10 sites in 3 countries.
10 sites in 3 countries
Hungary5 sites
Drug Research Center
Balatonfüred
Semmelweis University Department of Orthopedic
Budapest
Kenezy Gyula Hospital Department of Rheumatology
Debrecen
Szent Andras Hospital-Heviz
Hévíz
Szent Ferenc Hospital Department of Rheumatology
Miskolc
Israel3 sites
Hillel Yafe Medical Center - Endocrinology dep
Hadera
Rambam Medical Center
Haifa
Hadassah Medical Center Osteoporosis Center
Jerusalem
Czechia2 sites
Osteocentrum FN
Hradec Králové
Osteocentrum 3 .Interni Klinika 1. LFUK a VFN
Prague
About this study
Official title: A Multicenter, Randomized, Parallel Study to Assess the Clinical Efficacy, Safety, and Tolerability of ViaDerm-hPTH (1-34) in Comparison to Subcutaneous Injection of Forteo in Postmenopausal Women With Osteoporosis
The purpose of this study is to assess the clinical efficacy, safety, and tolerability of ViaDerm-shPTH [1-34] transdermal delivery in comparison to subcutaneous injection of rhPTH[1-34] following 3-month treatment in postmenopausal women with Osteoporosis
- Conditions
- Osteoporosis
- Being tested
- Teriparatide
- Keywords
- Osteoporosis, Transdermal, hPTH(1-34)
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TeriparatideDrug
Also called Forteo, Forsteo, LY333334
Daily for 96 days
| Study group | Role | What they receive |
|---|---|---|
| 50 mcg | Experimental | ViaDerm transdermal delivery Receives: Drug: Teriparatide |
| 80 mcg | Experimental | Add Via-Derm transdermal delivery Receives: Drug: Teriparatide |
| 20 mcg | Active comparator | Subcutaneous injection Receives: Drug: Teriparatide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline to endpoint 96 days in procollagen 1 N-terminal propeptide (P1NP)
Measured: Baseline, 96 days
Secondary outcomes (10)
Change from baseline in C-terminal telopeptide of type I collagen (CTX-1.)
Measured: Baseline, 96 days
hPTH (1-34) Pharmacokinetic AUC of ViaDerm-hPTH (1-34) and teriparatide SC.
Measured: Baseline, 96 days
Ratio of hPTH (1-34) AUC of transdermal treatment and subcutaneous injection
Measured: Baseline, 96 days
Ratio of hPTH (1-34) Cmax of transdermal treatment and subcutaneous injection
Measured: Baseline, 96 days
hPTH (1-34) Pharmacokinetic Cmax of ViaDerm-hPTH (1-34) and teriparatide SC.
Measured: Baseline, 96 Days
Percentage of patients with serum total calcium above the upper limit of normal range
Measured: Over 96 days
Percentage of patients with serum total calcium more than 1 mg/dl above the upper limit of normal range
Measured: Over 96 days
Number of participants with hPTH (1-34) specific antibody immune response
Measured: Baseline, 96 days
Draize score for erythema and edema
Measured: Over 96 Days
Visual Analog Scale (VAS) pain assessment
Measured: Over 96 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2007 (estimated)
- Study startApr 2008
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- TransPharma Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Eli Lilly and Company
- Investigators
- Efrat Kochba, MD, Study director, TransPharma-Medical Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00535860
- Sponsor's protocol ID
- CS 82-000-04
- Other IDs
- I2Y-MC-GHFE
- Status last verified
- Jul 2009
- First submitted
- 25 Sep 2007
- Last updated
- 10 Jul 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Parallel Study to Assess the Clinical Efficacy, Safety, and Tolerability of ViaDerm-hPTH (1-34) in Comparison to Subcutaneous Injection of Forteo in Postmenopausal Women With Osteoporosis
- ClinicalTrials.gov ID
- NCT00535860
- Acronym / sponsor ID
- CS 82-000-04
- Conditions
- Osteoporosis
- Keywords
- Osteoporosis, Transdermal, hPTH(1-34)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- TransPharma MedicalIndustry (pharma, biotech, devices)
- Collaborators
- Eli Lilly and Company
- Study start
- Apr 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 26 Sep 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the clinical efficacy, safety, and tolerability of ViaDerm-shPTH [1-34] transdermal delivery in comparison to subcutaneous injection of rhPTH[1-34] following 3-month treatment in postmenopausal women with Osteoporosis
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 |
|---|---|---|
| 50 mcg | Experimental | Drug: TeriparatideViaDerm transdermal delivery |
| 80 mcg | Experimental | Drug: TeriparatideAdd Via-Derm transdermal delivery |
| 20 mcg | Active comparator | Drug: TeriparatideSubcutaneous injection |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| TeriparatideAlso: Forteo, Forsteo, LY333334Daily for 96 days | Drug | 20 mcg, 50 mcg, 80 mcg |
Primary outcome
Change from baseline to endpoint 96 days in procollagen 1 N-terminal propeptide (P1NP)
Time frame: Baseline, 96 days
10 secondary outcomes
Change from baseline in C-terminal telopeptide of type I collagen (CTX-1.)
Time frame: Baseline, 96 days
hPTH (1-34) Pharmacokinetic AUC of ViaDerm-hPTH (1-34) and teriparatide SC.
Time frame: Baseline, 96 days
Ratio of hPTH (1-34) AUC of transdermal treatment and subcutaneous injection
Time frame: Baseline, 96 days
Ratio of hPTH (1-34) Cmax of transdermal treatment and subcutaneous injection
Time frame: Baseline, 96 days
hPTH (1-34) Pharmacokinetic Cmax of ViaDerm-hPTH (1-34) and teriparatide SC.
Time frame: Baseline, 96 Days
Percentage of patients with serum total calcium above the upper limit of normal range
Time frame: Over 96 days
Percentage of patients with serum total calcium more than 1 mg/dl above the upper limit of normal range
Time frame: Over 96 days
Number of participants with hPTH (1-34) specific antibody immune response
Time frame: Baseline, 96 days
Draize score for erythema and edema
Time frame: Over 96 Days
Visual Analog Scale (VAS) pain assessment
Time frame: Over 96 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2009.
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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.
Efrat Kochba, MD study director
TransPharma-Medical Ltd.
10 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Teriparatide in people with Osteoporosis, run by TransPharma Medical at 10 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 10 Jul 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Hungary, Israel, Czechia. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 to endpoint 96 days in procollagen 1 N-terminal propeptide (P1NP) (time frame: Baseline, 96 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Jul 2009.