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
Overview
- Phase
- Phase 2
- Intervention
- PTH analog
- Conditions
- Postmenopausal Osteoporosis
- Sponsor
- Unigene Laboratories Inc.
- Enrollment
- 97
- Locations
- 1
- Primary Endpoint
- % Change From Baseline BMD in L1-L4 Axial Lumbar Spine at Week 24
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief 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.
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.
Investigators
Eligibility 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
Arms & Interventions
PTH analog tablet
PTH(1-31) 5 mg tablet, once daily
Intervention: PTH analog
Placebo
Placebo matching tablet, once daily
Intervention: Placebo
Forsteo
Forsteo (teriparatide) 20 mcg SC Injection, once daily
Intervention: Forsteo (Teriparatide)
Outcomes
Primary Outcomes
% Change From Baseline BMD in L1-L4 Axial Lumbar Spine at Week 24
Time Frame: 24 weeks from baseline
Secondary Outcomes
- % Change From Baseline in Bone Resorption Marker (CTx-1) at Week 24(24 weeks from baseline)
- Systemic Absorption of PTH at Week 24(24 weeks)
- % Change From Baseline in Bone Formation Marker (P1NP) at Week 24(24 weeks from baseline)