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NCT Number: NCT01321723

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

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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Key information

Conditions

Postmenopausal Osteoporosis Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteoporosis Osteoporosis, Postmenopausal

Age range

45 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

CCBR, Aalborg, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PTH analog

Drug

A recombinant 1-31 amino acid fragment of PTH.

Other names: PTH(1-31)

Placebo

Drug

Forsteo (Teriparatide)

Drug

A recombinant 1-34 amino acid fragment of PTH.

Other names: Forteo (US)

Primary outcomes

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

    Time frame: 24 weeks from baseline

Secondary outcomes

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

    Time frame: 24 weeks from baseline

    Serum collagen type I (CTx-1) fragments generated during osteoclastic bone turnover are biomarkers for bone resorption. β-CrossLaps electrochemiluminescent sandwich immunoassay was used.

  2. Systemic Absorption of PTH at Week 24

    Time frame: 24 weeks

    AUC: (PTH analog tablets timepoints - baseline to 5.75 hours) (Forsteo injection timepoints - baseline to 2 hours)

  3. % Change From Baseline in Bone Formation Marker (P1NP) at Week 24

    Time frame: 24 weeks from baseline

Sponsors and collaborators

Lead sponsor

Unigene Laboratories Inc.

Industry

Collaborators

  • GlaxoSmithKline

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Mar 23, 2011
Registry last updated
Mar 1, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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