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Pharmacodynamics, Pharmacokinetics, Safety and Tolerability of PTH Analog Tablets in Postmenopausal Women

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ClinicalTrials.gov Identifier: NCT01321723
Recruitment Status : Completed
First Posted : March 23, 2011
Results First Posted : February 21, 2013
Last Update Posted : March 1, 2013
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Unigene Laboratories Inc.

Tracking Information
First Submitted Date  ICMJE March 16, 2011
First Posted Date  ICMJE March 23, 2011
Results First Submitted Date  ICMJE December 12, 2012
Results First Posted Date  ICMJE February 21, 2013
Last Update Posted Date March 1, 2013
Study Start Date  ICMJE February 2011
Actual Primary Completion Date October 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 17, 2013)
% Change From Baseline BMD in L1-L4 Axial Lumbar Spine at Week 24 [ Time Frame: 24 weeks from baseline ]
Original Primary Outcome Measures  ICMJE
 (submitted: March 22, 2011)
Change in bone mineral density (BMD) at the lumbar spine [ Time Frame: 24 weeks ]
Measured by DXA
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 21, 2013)
  • % Change From Baseline in Bone Resorption Marker (CTx-1) at Week 24 [ Time Frame: 24 weeks from baseline ]
    Serum collagen type I (CTx-1) fragments generated during osteoclastic bone turnover are biomarkers for bone resorption. β-CrossLaps electrochemiluminescent sandwich immunoassay was used.
  • Systemic Absorption of PTH at Week 24 [ Time Frame: 24 weeks ]
    AUC: (PTH analog tablets timepoints - baseline to 5.75 hours) (Forsteo injection timepoints - baseline to 2 hours)
  • % Change From Baseline in Bone Formation Marker (P1NP) at Week 24 [ Time Frame: 24 weeks from baseline ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 22, 2011)
  • Number of participants with AEs as a measure of safety and tolerability [ Time Frame: 24 weeks ]
  • Change in bone resorption marker CTx-1 [ Time Frame: 24 weeks ]
  • Systemic absorption of PTH analog [ Time Frame: 0 and 24 weeks ]
  • Change in bone formation marker (P1NP) [ Time Frame: 24 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pharmacodynamics, Pharmacokinetics, Safety and Tolerability of PTH Analog Tablets in Postmenopausal Women
Official Title  ICMJE A Double Blind, Randomized, Repeat Dose Parallel Group Study of Recombinant Human Parathyroid Hormone Analog Tablets, or Placebo Tablets, Compared to Open Label Forsteo® in Postmenopausal Women With Osteoporosis
Brief Summary This study is designed to provide information about the bone anabolic properties and absorption profile of Unigene's PTH Analog when administered as oral tablets over a period of 24 weeks to postmenopausal women with osteoporosis.
Detailed Description The choice of a 24-week treatment period was based on published studies of PTH which demonstrate its potential to produce a statistically significant increase in BMD in patients with postmenopausal osteoporosis within that observation period.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Postmenopausal Osteoporosis
Intervention  ICMJE
  • Drug: PTH analog
    A recombinant 1-31 amino acid fragment of PTH.
    Other Name: PTH(1-31)
  • Drug: Placebo
  • Drug: Forsteo (Teriparatide)
    A recombinant 1-34 amino acid fragment of PTH.
    Other Name: Forteo (US)
Study Arms  ICMJE
  • Experimental: PTH analog tablet
    PTH(1-31) 5 mg tablet, once daily
    Intervention: Drug: PTH analog
  • Placebo Comparator: Placebo
    Placebo matching tablet, once daily
    Intervention: Drug: Placebo
  • Active Comparator: Forsteo
    Forsteo (teriparatide) 20 mcg SC Injection, once daily
    Intervention: Drug: Forsteo (Teriparatide)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 17, 2013)
97
Original Estimated Enrollment  ICMJE
 (submitted: March 22, 2011)
93
Actual Study Completion Date  ICMJE October 2011
Actual Primary Completion Date October 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy postmenopausal women (45-80 years old) with a diagnosis of osteoporosis

Exclusion Criteria:

  • Use of estrogen or hormone replacement therapy
  • Use of bisphosphonates, strontium ranelate or denosumab
  • Use of parathyroid analogues or other bone metabolic agents
  • Medical conditions which might alter bone metabolism
  • Any known clinically significant disease affecting calcium metabolism or history of metabolic disorders including Paget's disease, osteogenesis imperfecta, or osteomalacia
  • Impairment of thyroid function
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 45 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark,   Estonia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01321723
Other Study ID Numbers  ICMJE UGL-OR1001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Unigene Laboratories Inc.
Study Sponsor  ICMJE Unigene Laboratories Inc.
Collaborators  ICMJE GlaxoSmithKline
Investigators  ICMJE
Principal Investigator: Christence S Teglbjaerg, MD CCBR
Principal Investigator: Bettina S Nedergaard, MD CCBR
Principal Investigator: Peter Alexandersen, MD CCBR
Principal Investigator: Ivo Valter, MD CCBR
PRS Account Unigene Laboratories Inc.
Verification Date January 2013

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