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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

97 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2011-10-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Postmenopausal Osteoporosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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PTH analog tablet

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

Group Type EXPERIMENTAL

PTH analog

Intervention Type DRUG

A recombinant 1-31 amino acid fragment of PTH.

Placebo

Placebo matching tablet, once daily

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Forsteo

Forsteo (teriparatide) 20 mcg SC Injection, once daily

Group Type ACTIVE_COMPARATOR

Forsteo (Teriparatide)

Intervention Type DRUG

A recombinant 1-34 amino acid fragment of PTH.

Interventions

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PTH analog

A recombinant 1-31 amino acid fragment of PTH.

Intervention Type DRUG

Placebo

Intervention Type DRUG

Forsteo (Teriparatide)

A recombinant 1-34 amino acid fragment of PTH.

Intervention Type DRUG

Other Intervention Names

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PTH(1-31) Forteo (US)

Eligibility Criteria

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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

Minimum Eligible Age

45 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No