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

Primary Purpose

Postmenopausal Osteoporosis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
PTH analog
Placebo
Forsteo (Teriparatide)
Sponsored by
Unigene Laboratories Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postmenopausal Osteoporosis focused on measuring Osteoporosis, Bone Diseases, Metabolic, Bone Diseases, Bone Density Conservation Agents

Eligibility Criteria

45 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • CCBR
  • CCBR
  • CCBR
  • CCBR

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Active Comparator

Arm Label

PTH analog tablet

Placebo

Forsteo

Arm Description

PTH(1-31) 5 mg tablet, once daily

Placebo matching tablet, once daily

Forsteo (teriparatide) 20 mcg SC Injection, once daily

Outcomes

Primary Outcome Measures

% Change From Baseline BMD in L1-L4 Axial Lumbar Spine at Week 24

Secondary Outcome Measures

% Change From Baseline in Bone Resorption Marker (CTx-1) at Week 24
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
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

Full Information

First Posted
March 16, 2011
Last Updated
February 21, 2013
Sponsor
Unigene Laboratories Inc.
Collaborators
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT01321723
Brief Title
Pharmacodynamics, Pharmacokinetics, Safety and Tolerability of PTH Analog Tablets in Postmenopausal Women
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 Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Unigene Laboratories Inc.
Collaborators
GlaxoSmithKline

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postmenopausal Osteoporosis
Keywords
Osteoporosis, Bone Diseases, Metabolic, Bone Diseases, Bone Density Conservation Agents

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
97 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PTH analog tablet
Arm Type
Experimental
Arm Description
PTH(1-31) 5 mg tablet, once daily
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo matching tablet, once daily
Arm Title
Forsteo
Arm Type
Active Comparator
Arm Description
Forsteo (teriparatide) 20 mcg SC Injection, once daily
Intervention Type
Drug
Intervention Name(s)
PTH analog
Other Intervention Name(s)
PTH(1-31)
Intervention Description
A recombinant 1-31 amino acid fragment of PTH.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Type
Drug
Intervention Name(s)
Forsteo (Teriparatide)
Other Intervention Name(s)
Forteo (US)
Intervention Description
A recombinant 1-34 amino acid fragment of PTH.
Primary Outcome Measure Information:
Title
% Change From Baseline BMD in L1-L4 Axial Lumbar Spine at Week 24
Time Frame
24 weeks from baseline
Secondary Outcome Measure Information:
Title
% Change From Baseline in Bone Resorption Marker (CTx-1) at Week 24
Description
Serum collagen type I (CTx-1) fragments generated during osteoclastic bone turnover are biomarkers for bone resorption. β-CrossLaps electrochemiluminescent sandwich immunoassay was used.
Time Frame
24 weeks from baseline
Title
Systemic Absorption of PTH at Week 24
Description
AUC: (PTH analog tablets timepoints - baseline to 5.75 hours) (Forsteo injection timepoints - baseline to 2 hours)
Time Frame
24 weeks
Title
% Change From Baseline in Bone Formation Marker (P1NP) at Week 24
Time Frame
24 weeks from baseline

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christence S Teglbjaerg, MD
Organizational Affiliation
CCBR
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bettina S Nedergaard, MD
Organizational Affiliation
CCBR
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Peter Alexandersen, MD
Organizational Affiliation
CCBR
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ivo Valter, MD
Organizational Affiliation
CCBR
Official's Role
Principal Investigator
Facility Information:
Facility Name
CCBR
City
Aalborg
Country
Denmark
Facility Name
CCBR
City
Ballerup
Country
Denmark
Facility Name
CCBR
City
Vejle
Country
Denmark
Facility Name
CCBR
City
Tallinn
Country
Estonia

12. IPD Sharing Statement

Citations:
PubMed Identifier
23234813
Citation
Henriksen K, Andersen JR, Riis BJ, Mehta N, Tavakkol R, Alexandersen P, Byrjalsen I, Valter I, Nedergaard BS, Teglbjaerg CS, Stern W, Sturmer A, Mitta S, Nino AJ, Fitzpatrick LA, Christiansen C, Karsdal MA. Evaluation of the efficacy, safety and pharmacokinetic profile of oral recombinant human parathyroid hormone [rhPTH(1-31)NH(2)] in postmenopausal women with osteoporosis. Bone. 2013 Mar;53(1):160-6. doi: 10.1016/j.bone.2012.11.045. Epub 2012 Dec 9.
Results Reference
result
PubMed Identifier
23719683
Citation
Sturmer A, Mehta N, Giacchi J, Cagatay T, Tavakkol R, Mitta S, Fitzpatrick L, Wald J, Trang J, Stern W. Pharmacokinetics of oral recombinant human parathyroid hormone [rhPTH(1-31)NH(2)] in postmenopausal women with osteoporosis. Clin Pharmacokinet. 2013 Nov;52(11):995-1004. doi: 10.1007/s40262-013-0083-4.
Results Reference
derived

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

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