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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 21, 2014