Status:
COMPLETED
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral Doses of PTH134 in Post-menopausal Women
Lead Sponsor:
Novartis
Conditions:
Post-menopausal Osteoporosis
Eligibility:
FEMALE
45-80 years
Phase:
PHASE1
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 ingredi...
Eligibility Criteria
Inclusion
- Post-menopausal women osteoporotic/osteopenic with an additional risk factor 45 to 80 years old
Exclusion
- 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.
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
104 Patients enrolled
Trial Details
Trial ID
NCT01224717
Start Date
September 1 2010
Last Update
May 13 2011
Active Locations (4)
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1
Novartis Investigative Site
Aalborg, Denmark
2
Novartis Investigative Site
Ballerup Municipality, Denmark
3
Novartis Investigative Site
Berlin, Germany
4
Novartis Investigative Site
Munich, Germany