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

Postmenopausal Osteoporosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01321723
• Other study ID #: UGL-OR1001
• Status: Completed
• Phase: Phase 2
• First received: March 16, 2011
• Last updated: February 21, 2013
• Start date: February 2011
• Est. completion date: October 2011

Study information

• Verified date: January 2013
• Source: Unigene Laboratories Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines AgencyEstonia: The State Agency of Medicine
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 97
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 45 Years to 80 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Osteoporosis
• Osteoporosis, Postmenopausal
• Postmenopausal Osteoporosis

Intervention

Drug:
• PTH analog
A recombinant 1-31 amino acid fragment of PTH.
• Placebo

• Forsteo (Teriparatide)
A recombinant 1-34 amino acid fragment of PTH.

Locations

Country	Name	City	State
Denmark	CCBR	Aalborg
Denmark	CCBR	Ballerup
Denmark	CCBR	Vejle
Estonia	CCBR	Tallinn

Sponsors (2)

Lead Sponsor	Collaborator
Unigene Laboratories Inc.	GlaxoSmithKline

Countries where clinical trial is conducted

Denmark,  Estonia, 

References & Publications (1)

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 pharmacok — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	% Change From Baseline BMD in L1-L4 Axial Lumbar Spine at Week 24		24 weeks from baseline	No
Secondary	% 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. ß-CrossLaps electrochemiluminescent sandwich immunoassay was used.	24 weeks from baseline	No
Secondary	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	No
Secondary	% Change From Baseline in Bone Formation Marker (P1NP) at Week 24		24 weeks from baseline	No