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

Unigene Laboratories

Status and phase: Completed; Phase 2

Conditions: Postmenopausal Osteoporosis

Treatments: Drug: Placebo; Drug: PTH analog; Drug: Forsteo (Teriparatide)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01321723

UGL-OR1001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 97 patients

Sex: Female

Ages: 45 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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97 participants in 3 patient groups, including a placebo group

PTH analog tablet

Experimental group

Description:

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

Treatment:

Drug: PTH analog

Placebo

Placebo Comparator group

Description:

Placebo matching tablet, once daily

Treatment:

Drug: Placebo

Forsteo

Active Comparator group

Description:

Forsteo (teriparatide) 20 mcg SC Injection, once daily

Treatment:

Drug: Forsteo (Teriparatide)