Postmenopausal women with established osteoporosis and at least two moderate or one severe prevalent fragility fracture. MedDRA version: 18.0 Level: LLT Classification code 10031288 Term: Osteoporosis with fracture System Organ Class: 100000004859
Conditions
Sponsors
Eli Lilly and Company Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Postmenopausal women = 45 years of age at the time of entry into the trial, whose last menstrual period occurred at least 2 years prior to entry into the trial, and are sufficiently mobile to complete study visits. Women 40 IU/L and serum estradiol level =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Increased baseline risk of osteosarcoma. This includes patients with Paget’s disease of the bone, previous primary skeletal malignancy, or skeletal exposure to therapeutic irradiation. As elevation of serum alkaline phosphatase activity may indicate the presence of Paget’s disease, an unexplained elevation of this enzyme activity will also be exclusionary. History of unresolved skeletal diseases that affect bone metabolism, other than osteoporosis, including renal osteodystrophy, osteomalacia, hyperparathyroidism (uncorrected), hypoparathyroidism, and intestinal malabsorption. Abnormally elevated values of serum albumin-corrected calcium levels at baseline, defined as = 10.6 mg/dL (or = 2.65 mmol/L). Abnormally low values of serum albumin- corrected calcium levels at baseline, defined as 72 pg/mL (or > 7.6 pmol/L). Severe vitamin D deficiency at baseline defined as 25-hydroxy-vitamin D levels 20 mg/day) for more than 3 months in the 2 years prior to Visit 1
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to evaluate if teriparatide 20 µg subcutaneously once daily is superior in reducing the incidence of new vertebral fractures during 24 months of therapy, when compared with risedronate 35 mg orally once weekly, in postmenopausal women with prevalent vertebral fragility fractures.;Secondary Objective: The key secondary objectives of this study are to evaluate if teriparatide 20 µg/day is superior in reducing the incidence of the following key outcomes during 24 months of therapy, when compared with risedronate 35 mg/week: 1. Incidence of pooled new and worsening vertebral fractures. 2. Incidence of pooled clinical fractures. 3. Incidence of non-vertebral fragility fractures. 4. Incidence of major non-vertebral fragility fractures: hip, radius, humerus, ribs, pelvis and ankle.;Primary end point(s): Incidence of new vertebral fractures;Timepoint(s) of evaluation of this end point: During the 24-month treatment phase | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Key secondary fracture endpoints : Incidence of pooled new and worsening vertebral fractures. Incidence of pooled clinical fractures. Incidence of non-vertebral fragility fractures. Incidence of major non-vertebral fragility fractures: hip, radius, humerus, ribs, pelvis, and ankle. ;Timepoint(s) of evaluation of this end point: During the 24-month treatment phase | — |
Countries
Argentina, Austria, Belgium, Brazil, Canada, Czech Republic, Germany, Greece, Hungary, Italy, Poland, Spain, United States
Contacts
Public ContactClinical Trial Information
Eli Lilly
Outcome results
None listed