Post-menopausal OsteoporosisPhase 1NCT01224717
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral Doses of PTH134 in Post-menopausal Women
A Phase 1 study testing PTH134 and Forsteo in people with Post-menopausal Osteoporosis, run by Novartis at 4 sites in 2 countries.
Trial summary
This study is designed to provide information about the bone-anabolic response of PTH134 when administered orally, in comparison to Forsteo®, the sub-cutaneous form of teriparatide, the active ingredient in PTH134. Read more about this study
- Who is it for?
- Ages 45 to 80 years, women only
- Conditions the study is for
- Post-menopausal Osteoporosis
- What is being tested?
- PTH134 and Forsteo
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Sep 2010to Apr 2011
- Phase
- Phase 1
- 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 45 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Post-menopausal women osteoporotic/osteopenic with an additional risk factor 45 to 80 years old
Who cannot join
- Use of estrogen or hormone replacement therapy
- Use of parathormone or parathormone fragments, calcitonin, aluminum supplements, within 12 months prior to first dose.
- Use of bisphosphonates and strontium ranelate
- Cancer or history of malignancy of any organ system
- Any radiation therapy to the skeleton.
- Any known clinically significant disease affecting calcium metabolism. Any history of metabolic disorders including Paget's disease, osteogenesis imperfecta, or osteomalacia.
- History or clinical evidence of any impairment of thyroid function
- Other protocol-defined inclusion/exclusion criteria apply.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Denmark2 sites
Novartis Investigative Site
Aalborg
Novartis Investigative Site
Ballerup Municipality
Germany2 sites
Novartis Investigative Site
Berlin
Novartis Investigative Site
Munich
About this study
Official title: A Phase I, Partially Blinded, Randomized, Placebo Controlled, Active Comparator Study to Explore the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Post-menopausal Women After Daily Oral Doses of PTH134
This study is designed to provide information about the bone-anabolic response of PTH134 when administered orally, in comparison to Forsteo®, the sub-cutaneous form of teriparatide, the active ingredient in PTH134.
- Conditions
- Post-menopausal Osteoporosis
- Being tested
- PTH134, Placebo, Forsteo
- Keywords
- Osteoporosis
- Medical subject headings
- Osteoporosis, Postmenopausal, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PTH134Drug
PlaceboDrug
ForsteoDrug
| Study group | Role | What they receive |
|---|---|---|
| PTH134 | Experimental | Not described Receives: Drug: PTH134 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Forsteo | Active comparator | Not described Receives: Drug: Forsteo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure: Effects of treatment on bone biomarkers. Measure levels of PINP, CTX-1, and serum calcium levels, serum phosphate, P1CP, bone-specific alkaline phosphatase, osteocalcin.
Measured: 12 weeks
Secondary outcomes (1)
Change from baseline in serum calcium levels after 12 weeks of treatment
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2010 (estimated)
- Study startSep 2010
- Primary completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-menopausal 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 1
- 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
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01224717
- Sponsor's protocol ID
- CPTH134A2102
- Other IDs
- 2009-015933-64, 2009
- Status last verified
- May 2011
- First submitted
- 18 Oct 2010
- Last updated
- 13 May 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Partially Blinded, Randomized, Placebo Controlled, Active Comparator Study to Explore the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Post-menopausal Women After Daily Oral Doses of PTH134
- ClinicalTrials.gov ID
- NCT01224717
- Acronym / sponsor ID
- CPTH134A2102
- Conditions
- Post-menopausal Osteoporosis
- Keywords
- Osteoporosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Sep 2010
- Primary completion
- Apr 2011 (actual)
- First posted
- 20 Oct 2010 (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.
This study is designed to provide information about the bone-anabolic response of PTH134 when administered orally, in comparison to Forsteo®, the sub-cutaneous form of teriparatide, the active ingredient in PTH134.
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 |
|---|---|---|
| PTH134 | Experimental | Drug: PTH134 |
| Placebo | Placebo comparator | Drug: Placebo |
| Forsteo | Active comparator | Drug: Forsteo |
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)
- Post-menopausal women osteoporotic/osteopenic with an additional risk factor 45 to 80 years old
Key exclusion criteria (8 listed)
- Use of estrogen or hormone replacement therapy
- Use of parathormone or parathormone fragments, calcitonin, aluminum supplements, within 12 months prior to first dose.
- Use of bisphosphonates and strontium ranelate
- Cancer or history of malignancy of any organ system
- Any radiation therapy to the skeleton.
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 |
|---|---|---|
| PTH134 | Drug | PTH134 |
| Placebo | Drug | Placebo |
| Forsteo | Drug | Forsteo |
Primary outcome
Measure: Effects of treatment on bone biomarkers. Measure levels of PINP, CTX-1, and serum calcium levels, serum phosphate, P1CP, bone-specific alkaline phosphatase, osteocalcin.
Time frame: 12 weeks
1 secondary outcome
Change from baseline in serum calcium levels after 12 weeks of treatment
Time frame: 12 weeks
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 13 May 2011.
Related trials for Post-menopausal Osteoporosis
Recruiting
Study of the Impact of Mother-of-pearl Nutritional Supplementation on the Prevention of Post-menopausal Osteoporosis
Post Menopausal Osteoporosis
RecruitingPhase 4
The Comparison of Ibandronate and Zoledronic Acid After Denosumab Discontinuation
Postmenopausal Osteoporosis, Postmenopausal Osteopenia
Not yet recruitingPhase 4
Sequential Treatment With Romosozumab Followed by Denosumab vs. Zoledronic Acid for Gains in HIP BMD
Osteoporosis in Post-menopausal Women
RecruitingObservational study
Sequential Therapies After Osteoanabolic Treatment
Osteoporosis, Postmenopausal
Not yet recruitingObservational study
A Retrospective and Prospective Clinical Registry for Data Collection of Perimenopausal, Menopausal and Premature Ovarian Insufficiency Women
Menopause, Menopausal Hormone Therapy
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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PTH134 and Forsteo in people with Post-menopausal Osteoporosis, run by Novartis 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 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 13 May 2011. 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, Germany. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Measure: Effects of treatment on bone biomarkers. Measure levels of PINP, CTX-1, and serum calcium levels, serum phosphate, P1CP, bone-specific alkaline phosphatase, osteocalcin. (time frame: 12 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 13 May 2011.