Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral Doses of PTH134 in Post-menopausal Women
Phase 1
Completed
- Conditions
- Post-menopausal Osteoporosis
- Interventions
- Registration Number
- NCT01224717
- Lead Sponsor
- Novartis
- Brief Summary
This study is designed to provide information about the bone-anabolic response of PTH134 when administered orally, in comparison to Forsteo®, the sub-cutaneous form of teriparatide, the active ingredient in PTH134.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 104
Inclusion Criteria
- Post-menopausal women osteoporotic/osteopenic with an additional risk factor 45 to 80 years old
Exclusion Criteria
- Use of estrogen or hormone replacement therapy
- Use of parathormone or parathormone fragments, calcitonin, aluminum supplements, within 12 months prior to first dose.
- Use of bisphosphonates and strontium ranelate
- Cancer or history of malignancy of any organ system
- Any radiation therapy to the skeleton.
- Any known clinically significant disease affecting calcium metabolism. Any history of metabolic disorders including Paget's disease, osteogenesis imperfecta, or osteomalacia.
- History or clinical evidence of any impairment of thyroid function
- Other protocol-defined inclusion/exclusion criteria apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PTH134 PTH134 - Placebo Placebo - Forsteo Forsteo -
- Primary Outcome Measures
Name Time Method Measure: Effects of treatment on bone biomarkers. Measure levels of PINP, CTX-1, and serum calcium levels, serum phosphate, P1CP, bone-specific alkaline phosphatase, osteocalcin. 12 weeks
- Secondary Outcome Measures
Name Time Method Change from baseline in serum calcium levels after 12 weeks of treatment 12 weeks
Trial Locations
- Locations (1)
Novartis Investigative Site
🇩🇪Munich, Germany