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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01321723
Recruitment Status : Completed
First Posted : March 23, 2011
Results First Posted : February 21, 2013
Last Update Posted : March 1, 2013
Information provided by (Responsible Party):
Unigene Laboratories Inc.

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.

Condition or disease Intervention/treatment Phase
Postmenopausal Osteoporosis Drug: PTH analog Drug: Placebo Drug: Forsteo (Teriparatide) Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 97 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : February 2011
Actual Primary Completion Date : October 2011
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoporosis

Arm Intervention/treatment
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)

Primary Outcome Measures :
  1. % Change From Baseline BMD in L1-L4 Axial Lumbar Spine at Week 24 [ Time Frame: 24 weeks from baseline ]

Secondary Outcome Measures :
  1. % 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.

  2. 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)

  3. % Change From Baseline in Bone Formation Marker (P1NP) at Week 24 [ Time Frame: 24 weeks from baseline ]

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01321723

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Aalborg, Denmark
Ballerup, Denmark
Vejle, Denmark
Tallinn, Estonia
Sponsors and Collaborators
Unigene Laboratories Inc.
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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
Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Unigene Laboratories Inc. Identifier: NCT01321723    
Other Study ID Numbers: UGL-OR1001
First Posted: March 23, 2011    Key Record Dates
Results First Posted: February 21, 2013
Last Update Posted: March 1, 2013
Last Verified: January 2013
Keywords provided by Unigene Laboratories Inc.:
Bone Diseases, Metabolic
Bone Diseases
Bone Density Conservation Agents
Additional relevant MeSH terms:
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Osteoporosis, Postmenopausal
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Bone Density Conservation Agents