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Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral Doses of PTH134 in Post-menopausal Women

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT01224717
First received: October 18, 2010
Last updated: May 12, 2011
Last verified: May 2011
History of Changes

October 18, 2010
May 12, 2011
September 2010
April 2011   (final data collection date for 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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01224717 on ClinicalTrials.gov Archive Site
Change from baseline in serum calcium levels after 12 weeks of treatment [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral Doses of PTH134 in Post-menopausal Women
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Post-menopausal Osteoporosis
  • Drug: PTH134
  • Drug: Placebo
  • Drug: Forsteo
  • Experimental: PTH134
    Intervention: Drug: PTH134
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Active Comparator: Forsteo
    Intervention: Drug: Forsteo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
104
Not Provided
April 2011   (final data collection date for primary outcome measure)

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.
Female
45 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Denmark,   Germany
 
NCT01224717
CPTH134A2102, 2009-015933-64
Not Provided
External Affairs, Novartis Pharamceuticals
Novartis
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP