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

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

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.

Study Overview

• Status: Completed
• Conditions: Postmenopausal Osteoporosis
• Intervention / Treatment: Drug: Placebo; Drug: PTH analog; Drug: Forsteo (Teriparatide)

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: Interventional
• Enrollment (Actual): 97
• Phase: Phase 2

Contacts and Locations

Study Locations

• Denmark
  • Aalborg, Denmark
    • CCBR
  • Ballerup, Denmark
    • CCBR
  • Vejle, Denmark
    • CCBR
• Estonia
  • Tallinn, Estonia
    • CCBR

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / 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 Names: 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 Names: Forteo (US)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
% Change From Baseline BMD in L1-L4 Axial Lumbar Spine at Week 24	24 weeks from baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
% 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.	24 weeks from baseline
Systemic Absorption of PTH at Week 24	AUC: (PTH analog tablets timepoints - baseline to 5.75 hours) (Forsteo injection timepoints - baseline to 2 hours)	24 weeks
% Change From Baseline in Bone Formation Marker (P1NP) at Week 24		24 weeks from baseline

Collaborators and Investigators

• Sponsor: Unigene Laboratories Inc.
• Collaborators: 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

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Actual): October 1, 2011
• Study Completion (Actual): October 1, 2011

Study Registration Dates

• First Submitted: March 16, 2011
• First Submitted That Met QC Criteria: March 22, 2011
• First Posted (Estimate): March 23, 2011

Study Record Updates

• Last Update Posted (Estimate): March 1, 2013
• Last Update Submitted That Met QC Criteria: February 21, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Keywords: Osteoporosis; Bone Diseases; Bone Density Conservation Agents; Bone Diseases, Metabolic
• Additional Relevant MeSH Terms: Metabolic Diseases; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Metabolic; Osteoporosis; Osteoporosis, Postmenopausal; Physiological Effects of Drugs; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Teriparatide
• Other Study ID Numbers: UGL-OR1001