Back to resultsSafety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral Doses of PTH134 in Post-menopausal Women
Primary Purpose
Post-menopausal Osteoporosis
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
PTH134
Placebo
Forsteo
Sponsored by
About this trial
This is an interventional treatment trial for Post-menopausal Osteoporosis focused on measuring Osteoporosis
Eligibility Criteria
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.
Sites / Locations
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Placebo Comparator
Active Comparator
Arm Label
PTH134
Placebo
Forsteo
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Change from baseline in serum calcium levels after 12 weeks of treatment
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01224717
Brief Title
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral Doses of PTH134 in Post-menopausal Women
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Novartis
4. Oversight
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-menopausal Osteoporosis
Keywords
Osteoporosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
104 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PTH134
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
Forsteo
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
PTH134
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Type
Drug
Intervention Name(s)
Forsteo
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Change from baseline in serum calcium levels after 12 weeks of treatment
Time Frame
12 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Aalborg
Country
Denmark
Facility Name
Novartis Investigative Site
City
Ballerup
Country
Denmark
Facility Name
Novartis Investigative Site
City
Berlin
Country
Germany
Facility Name
Novartis Investigative Site
City
Munich
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral Doses of PTH134 in Post-menopausal Women
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