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

Information source: Unigene Laboratories Inc.
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Postmenopausal Osteoporosis

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

Phase: Phase 2

Status: Completed

Sponsored by: Unigene Laboratories Inc.

Official(s) and/or principal investigator(s):
Christence S Teglbjaerg, MD, Principal Investigator, Affiliation: CCBR
Bettina S Nedergaard, MD, Principal Investigator, Affiliation: CCBR
Peter Alexandersen, MD, Principal Investigator, Affiliation: CCBR
Ivo Valter, MD, Principal Investigator, Affiliation: CCBR

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.

Clinical Details

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 ForsteoŽ in Postmenopausal Women With Osteoporosis

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

Primary outcome: % Change From Baseline BMD in L1-L4 Axial Lumbar Spine at Week 24

Secondary outcome:

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

Systemic Absorption of PTH at Week 24

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

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.

Eligibility

Minimum age: 45 Years. Maximum age: 80 Years. Gender(s): Female.

Criteria:

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

Locations and Contacts

CCBR, Aalborg, Denmark

CCBR, Ballerup, Denmark

CCBR, Vejle, Denmark

CCBR, Tallinn, Estonia

Additional Information

Starting date: February 2011
Last updated: February 21, 2013

Page last updated: August 20, 2015

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