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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
  Purpose

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.


Condition Intervention Phase
Post-menopausal Osteoporosis
 Drug: PTH134
Drug: Placebo
Drug: Forsteo
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novartis:

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. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in serum calcium levels after 12 weeks of treatment [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 104
Study Start Date: September 2010
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PTH134 Drug: PTH134
Placebo Comparator: Placebo Drug: Placebo
Active Comparator: Forsteo Drug: Forsteo

  Eligibility

Ages Eligible for Study:   45 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01224717

Locations
Denmark
Novartis Investigative Site
Aalborg, Denmark
Novartis Investigative Site
Ballerup, Denmark
Germany
Novartis Investigative Site
Berlin, Germany
Novartis Investigative Site
Munich, Germany
Sponsors and Collaborators
Novartis
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: External Affairs, Novartis Pharamceuticals
ClinicalTrials.gov Identifier: NCT01224717     History of Changes
Other Study ID Numbers: CPTH134A2102, 2009-015933-64
Study First Received: October 18, 2010
Last Updated: May 12, 2011
Health Authority: Denmark: Danish Medicines Agency

Keywords provided by Novartis:
Osteoporosis

Additional relevant MeSH terms:
Osteoporosis
Osteoporosis, Postmenopausal
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
 Teriparatide
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013