- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01224717
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral Doses of PTH134 in Post-menopausal Women
May 12, 2011 updated by: Novartis
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
104
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
45 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Post-menopausal women osteoporotic/osteopenic with an additional risk factor 45 to 80 years old
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
|
|
Experimental: PTH134
|
|
Active Comparator: Forsteo
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change from baseline in serum calcium levels after 12 weeks of treatment
Time Frame: 12 weeks
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2010
Primary Completion (Actual)
April 1, 2011
Study Registration Dates
First Submitted
October 18, 2010
First Submitted That Met QC Criteria
October 19, 2010
First Posted (Estimate)
October 20, 2010
Study Record Updates
Last Update Posted (Estimate)
May 13, 2011
Last Update Submitted That Met QC Criteria
May 12, 2011
Last Verified
May 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CPTH134A2102
- 2009-015933-64 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Post-menopausal Osteoporosis
-
Hoffmann-La RocheCompletedPost Menopausal OsteoporosisAustralia, United Kingdom, United States, Brazil, Germany, South Africa, France, Spain, Switzerland, Italy, Canada, Hungary, Belgium, Mexico, Poland, Denmark, Norway, Czechia, Romania
-
University College, LondonWithdrawnPost-menopausal OsteoporosisUnited Kingdom
-
Hoffmann-La RocheCompletedPost Menopausal OsteoporosisPhilippines, Taiwan, Thailand, Hong Kong, Indonesia
-
Centre Hospitalier Universitaire de Saint EtienneMinistry of Health, FranceRecruitingPost Menopausal OsteoporosisFrance
-
AmgenCompletedPost Menopausal OsteoporosisFrance
-
Hoffmann-La RocheCompletedPost Menopausal OsteoporosisUnited States
-
Hoffmann-La RocheCompletedPost Menopausal OsteoporosisSpain, South Africa, Germany, Mexico, United States, Canada, France, United Kingdom, Italy, Belgium, Australia, Poland, Denmark, Hungary, Czech Republic, Norway
-
Hoffmann-La RocheGlaxoSmithKlineCompletedPost Menopausal OsteoporosisFrance
-
Novartis PharmaceuticalsCompletedPost-menopausal OsteoporosisColombia, Belgium, Sweden, Hong Kong, United States, Hungary, Switzerland, Australia, Germany, Italy, Canada, Poland, Argentina, Thailand, Norway, New Zealand, France, Finland
-
Hoffmann-La RocheCompletedPost Menopausal OsteoporosisUnited States, Puerto Rico
Clinical Trials on Placebo
-
SamA Pharmaceutical Co., LtdUnknownAcute Bronchitis | Acute Upper Respiratory Tract InfectionKorea, Republic of
-
National Institute on Drug Abuse (NIDA)CompletedCannabis UseUnited States
-
AstraZenecaParexel; Spandauer Damm 130; 14050; Berlin, GermanyCompletedMale Subjects With Type II Diabetes (T2DM)Germany
-
Heptares Therapeutics LimitedCompletedPharmacokinetics | Safety IssuesUnited Kingdom
-
GlaxoSmithKlineCompletedPulmonary Disease, Chronic ObstructiveUnited Kingdom, Netherlands
-
Shijiazhuang Yiling Pharmaceutical Co. LtdXuanwu Hospital, BeijingCompleted
-
ItalfarmacoCompletedBecker Muscular DystrophyNetherlands, Italy
-
GlaxoSmithKlineCompletedInfections, BacterialUnited States
-
West Penn Allegheny Health SystemCompletedAsthma | Allergic RhinitisUnited States