Post-menopausal Osteoporosis
Conditions
Keywords
Osteoporosis
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.
Sponsors
Novartis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
45 Years to 80 Years
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Change from baseline in serum calcium levels after 12 weeks of treatment | 12 weeks |
Countries
Denmark, Germany
Outcome results
None listed