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

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Unigene Laboratories Inc.
ClinicalTrials.gov Identifier:
NCT01321723
First received: March 16, 2011
Last updated: February 21, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
Postmenopausal Osteoporosis
Drug: PTH analog
Drug: Placebo
Drug: Forsteo (Teriparatide)
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Unigene Laboratories Inc.:

Primary Outcome Measures:
  • % Change From Baseline BMD in L1-L4 Axial Lumbar Spine at Week 24 [ Time Frame: 24 weeks from baseline ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • % Change From Baseline in Bone Resorption Marker (CTx-1) at Week 24 [ Time Frame: 24 weeks from baseline ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

Enrollment: 97
Study Start Date: February 2011
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PTH analog tablet
PTH(1-31) 5 mg tablet, once daily
Drug: PTH analog
A recombinant 1-31 amino acid fragment of PTH.
Other Name: PTH(1-31)
Placebo Comparator: Placebo
Placebo matching tablet, once daily
Drug: Placebo
Active Comparator: Forsteo
Forsteo (teriparatide) 20 mcg SC Injection, once daily
Drug: Forsteo (Teriparatide)
A recombinant 1-34 amino acid fragment of PTH.
Other Name: Forteo (US)

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.

  Eligibility

Ages Eligible for Study:   45 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01321723

Locations
Denmark
CCBR
Aalborg, Denmark
CCBR
Ballerup, Denmark
CCBR
Vejle, Denmark
Estonia
CCBR
Tallinn, Estonia
Sponsors and Collaborators
Unigene Laboratories Inc.
GlaxoSmithKline
Investigators
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
  More Information

No publications provided by Unigene Laboratories Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Unigene Laboratories Inc.
ClinicalTrials.gov Identifier: NCT01321723     History of Changes
Other Study ID Numbers: UGL-OR1001
Study First Received: March 16, 2011
Results First Received: December 12, 2012
Last Updated: February 21, 2013
Health Authority: Denmark: Danish Medicines Agency
Estonia: The State Agency of Medicine

Keywords provided by Unigene Laboratories Inc.:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Bone Density Conservation Agents

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 April 14, 2014