OsteoporosisPhase 3NCT03002428
A Comparison of PF708 and Forteo in Osteoporosis Patients
A Phase 3 study testing Teriparatide (PF708) and Teriparatide (Forteo) in people with Osteoporosis, run by Pfenex, Inc at 26 sites in United States.
Trial summary
The purpose of this study is to compare the effects of two teriparatide products, PF708 and Forteo, in patients with osteoporosis. Read more about this study
- Who is it for?
- Ages 30 to 85 years
- Conditions the study is for
- Osteoporosis
- What is being tested?
- Teriparatide (PF708) and Teriparatide (Forteo)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 181 participants
- Where
- 26 sitesUnited States
- Study dates
- Dec 2016to May 2018
- Phase
- Phase 3
- 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 30 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- If female, ≥5 years postmenopausal at the time of screening, with a DXA-derived BMD value at least 1 standard deviation (SD) below the average of young, healthy women
- If male, has a DXA-derived BMD value at least 2 SD below the average of young, healthy men
- Able to use the pen injection device correctly
- Able to understand and sign the written Informed Consent Form (ICF)
Who cannot join
- Treatment with oral bisphosphonates (once daily or once weekly) within 6 months of screening
- Any current or prior human PTH-derived products (e.g., Forteo, Teribone, Natpara), including for investigational purposes
- Immobility due to severe or chronically disabling conditions (e.g., stroke, Parkinson's disease, multiple sclerosis)
- History of metabolic bone diseases other than osteoporosis
- History of malignant disease, including solid tumors and hematologic malignancies (except basal cell and squamous cell carcinomas of the skin that have been completely excised and are considered cured)
- History of Paget's disease of bone
- History of prior external beam or implant radiation therapy involving the skeleton
- Active urolithiasis or primary hyperparathyroidism
Trial locations and contacts
26 sites in 1 country.
26 sites in 1 country
United States26 sites
Radiant Research
Akron, Ohio, 44311
New Mexico Clinical Research & Osteoporosis Center
Albuquerque, New Mexico, 87106
Atlanta Research Center
Atlanta, Georgia, 30319
Radiant Research
Birmingham, Alabama, 35211
Radiant Research
Bridgeton, Missouri, 63044
Radiant Research
Chandler, Arizona, 85224
Radiant Research
Chicago, Illinois, 60602
Radiant Research
Cincinnati, Ohio, 45236
Radiant Research
Colorado Springs, Colorado, 80909
Radiant Research
Dallas, Texas, 75231
Spectrum Medical
Danville, Virginia, 24541
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635
Lillestol Research
Fargo, North Dakota, 58103
Radiant Research
Henderson, Nevada, 89074
Radiant Research
Las Vegas, Nevada, 89128
OB-GYN Associates of Mid-Florida
Leesburg, Florida, 34748
Radiant Research
Mesa, Arizona, 85213
The Orthopaedic Group
Mobile, Alabama, 36608
Radiant Research
Papillion, Nebraska, 68046
SunValley Arthritis Center
Peoria, Arizona, 85381
Radiant Research
Phoenix, Arizona, 85020
Radiant Research
Plano, Texas, 75093
Radiant Research
Puyallup, Washington, 98372
Radiant Research
San Antonio, Texas, 78229
Radiant Research
San Antonio, Texas, 78240
Pennsylvania Regional Center for Arthritis & Osteoporosis Research
Wyomissing, Pennsylvania, 19610
About this study
Official title: A Randomized Study Comparing the Effects of PF708 and Forteo in Patients With Osteoporosis
The purpose of this study is to compare the effects of two teriparatide products, PF708 and Forteo, in patients with osteoporosis.
Read the detailed description
This is a randomized, multi-center study conducted in the United States. Men and women with osteoporosis will be enrolled in a parallel-group, open-label study design to compare the effects of PF708 and Forteo after 24 weeks of treatment. Half of the subjects will be randomized to receive PF708, and the other half will be randomized to receive Forteo.
- Conditions
- Osteoporosis
- Being tested
- Teriparatide (PF708), Teriparatide (Forteo)
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Teriparatide (PF708)Drug
Subcutaneous injection
Teriparatide (Forteo)Drug
Subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Teriparatide (PF708) | Experimental | PF708 20 mcg once-daily subcutaneous injection for 24 weeks Receives: Drug: Teriparatide (PF708) |
| Teriparatide (Forteo) | Active comparator | Forteo 20 mcg once-daily subcutaneous injection for 24 weeks Receives: Drug: Teriparatide (Forteo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood levels of anti-drug antibody (ADA) against teriparatide
Measured: 24 weeks
Secondary outcomes (5)
Mean percentage change in lumbar-spine bone mineral density (BMD)
Measured: 24 weeks
Median percentage change in serum N-terminal propeptide of type 1 procollagen (P1NP)
Measured: 24 weeks
Median percentage change in serum crosslinked C-terminal telopeptide of type 1 collagen (CTX)
Measured: 24 weeks
Plasma maximum concentration (Cmax) of teriparatide
Measured: 4 hours
Plasma area-under-the-curve (AUC) of teriparatide
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2016 (estimated)
- Study startDec 2016
- Primary completionMay 2018
- Study completionMay 2018
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 181 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfenex, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hubert C Chen, MD, Study director, Pfenex, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03002428
- Sponsor's protocol ID
- PF708-301
- Status last verified
- May 2018
- First submitted
- 21 Dec 2016
- Last updated
- 23 May 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Study Comparing the Effects of PF708 and Forteo in Patients With Osteoporosis
- ClinicalTrials.gov ID
- NCT03002428
- Acronym / sponsor ID
- PF708-301
- Conditions
- Osteoporosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 181 participants (actual)
- Lead sponsor
- Pfenex, IncIndustry (pharma, biotech, devices)
- Study start
- Dec 2016 (actual)
- Primary completion
- May 2018 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 23 Dec 2016 (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 compare the effects of two teriparatide products, PF708 and Forteo, in patients with osteoporosis.
Detailed description
This is a randomized, multi-center study conducted in the United States. Men and women with osteoporosis will be enrolled in a parallel-group, open-label study design to compare the effects of PF708 and Forteo after 24 weeks of treatment. Half of the subjects will be randomized to receive PF708, and the other half will be randomized to receive Forteo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Teriparatide (PF708) | Experimental | Drug: Teriparatide (PF708)PF708 20 mcg once-daily subcutaneous injection for 24 weeks |
| Teriparatide (Forteo) | Active comparator | Drug: Teriparatide (Forteo)Forteo 20 mcg once-daily subcutaneous injection for 24 weeks |
Who may qualify
- Ages
- 30 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- If female, ≥5 years postmenopausal at the time of screening, with a DXA-derived BMD value at least 1 standard deviation (SD) below the average of young, healthy women
- If male, has a DXA-derived BMD value at least 2 SD below the average of young, healthy men
- Able to use the pen injection device correctly
- Able to understand and sign the written Informed Consent Form (ICF)
Key exclusion criteria (8 listed)
- Treatment with oral bisphosphonates (once daily or once weekly) within 6 months of screening
- Any current or prior human PTH-derived products (e.g., Forteo, Teribone, Natpara), including for investigational purposes
- Immobility due to severe or chronically disabling conditions (e.g., stroke, Parkinson's disease, multiple sclerosis)
- History of metabolic bone diseases other than osteoporosis
- History of malignant disease, including solid tumors and hematologic malignancies (except basal cell and squamous cell carcinomas of the skin that have been completely excised and are considered cured)
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 |
|---|---|---|
| Teriparatide (PF708)Subcutaneous injection | Drug | Teriparatide (PF708) |
| Teriparatide (Forteo)Subcutaneous injection | Drug | Teriparatide (Forteo) |
Primary outcome
Blood levels of anti-drug antibody (ADA) against teriparatide
Time frame: 24 weeks
5 secondary outcomes
Mean percentage change in lumbar-spine bone mineral density (BMD)
Time frame: 24 weeks
Median percentage change in serum N-terminal propeptide of type 1 procollagen (P1NP)
Time frame: 24 weeks
Median percentage change in serum crosslinked C-terminal telopeptide of type 1 collagen (CTX)
Time frame: 24 weeks
Plasma maximum concentration (Cmax) of teriparatide
Time frame: 4 hours
Plasma area-under-the-curve (AUC) of teriparatide
Time frame: 4 hours
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 23 May 2018.
- Individual participant dataSharing planned: No
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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.
Hubert C Chen, MD study director
Pfenex, Inc
26 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Teriparatide (PF708) and Teriparatide (Forteo) in people with Osteoporosis, run by Pfenex, Inc at 26 sites in United States.
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 4 inclusion and 8 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 23 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in United States. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Blood levels of anti-drug antibody (ADA) against teriparatide (time frame: 24 weeks). 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 23 May 2018.