chronic back pain and osteoporotic vertebral fracture(s)
Conditions
Interventions
Product Name: teriparatide
Product Code: LY333334
Pharmaceutical Form: Solution for injection
INN or Proposed INN: teriparatide
Current Sponsor code: LY333334
Concentration unit: µg/ml microgram(s)/mi
Sponsors
Eli Lilly and Company Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: [1] Postmenopausal women 45 years of age and older 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 below the age of 55 years in whom a bilateral oophorectomy cannot clearly be documented must have their postmenopausal status confirmed by a serum follicle stimulating hormone level >30 IU/L and serum estradiol level =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: [9] 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 skeletal alkaline phosphatase activity may indicate the presence of Paget’s disease, an unexplained elevation of this enzyme activity will also be exclusionary. [10] Currently active or suspected diseases that affect bone metabolism, other than osteoporosis (such as renal osteodystrophy, osteomalacia, hyperparathyroidism, hypoparathyroidism, hyperthyroidism, sprue, inflammatory bowel disease, or malabsorption). [11] Patients who are imminent candidates for kyphoplasty or vertebroplasty. Patients who require kyphoplasty or vertebroplasty after 6 months of treatment in this study will be allowed to continue in the study. [12] Elevated serum calcium values, or abnormal serum thyroid-stimulating hormone, parathyroid hormone (PTH), or 25-hydroxyvitamin D levels, based on central laboratory reference ranges. Patients with minimal alterations of these labs may potentially be allowed in this study if there are no safety concerns, based on the opinion of both the investigator and the Lilly clinical research physician. Appropriate documentation of any such discussions is required. [13] Clinical signs or symptoms, previous diagnostic imaging, lab test, or neurodiagnostic evidence of significant pathology which may be related to back pain and which would make interpretation of the back pain related to an osteoporotic vertebral fracture difficult or impossible, based on investigator assessment. Examples of such pathology would include (but are not limited to): • radiculopathic/neuropathic pain due to nerve root compression of any cause • significant spondylolisthesis, spinal stenosis, lateral recess stenosis • spinal or paraspinal masses (such as tumors, metastases, angiomas, or abscesses) • infectious or inflammatory processes of the spine or paraspinal region. [14] Poor medical or psychiatric condition for participating in a clinical study, in the opinion of the investigator. [15] History of excessive consumption of alcohol or abuse of drugs in the 1 year prior to Visit 2, in the opinion of the investigator. [16] History of malignant neoplasms in the 5 years prior to Visit 2, with the exception of superficial basal cell or squamous cell carcinomas of the skin that have been definitively treated. Subjects with carcinoma in situ of the uterine cervix treated definitively more than 1 year prior to entry into the study may be randomized. Patients with multiple myeloma or metastases to bone are excluded [17] Active liver disease or clinical jaundice. Significantly impaired hepatic function, defined as ALT>75 U/L or GGT >300U/L. [18] Significantly impaired renal function as defined by the following criteria: • Significantly impaired renal function as defined as serum creatinine >2.0 mg/dL or 176.8 mmol/L. [19] Patients with a history of nephrolithiasis or urolithiasis within 2 years prior to Visit 2. [20] Patients with known contraindications to risedronate therapy or active or recent history of significant upper gastrointestinal disorders. [21] Treatment with: • oral strontium ranelate for any duration • fluoride at therapeutic doses (=20 mg/day) for more than 3 months during the last 2 years or for more than a total of 2 years, or any dosages within the 6 months prior to Visit 2 (previous or current use of fluoridated water or topical dental f
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to compare the efficacy of teriparatide 20 µg/day versus risedronate 35 mg/week on the reduction of back pain in postmenopausal women with prevalent osteoporotic vertebral fractures associated with chronic back pain.;Secondary Objective: • Measure of pain score collected via daily diary during the 7 days prior to each scheduled visit, the proportion of patients demonstrating at least a 30% reduction in severity of worst and average back pain from baseline to the following timepoints: 12 and 18 months, and 6, 12 and 18 moths respectively. • Measure of pain score collected via daily diary during the 7 days prior to each scheduled visit, the time-to-first occurrence of a =30% reduction compared to the baseline pain score in worst and average back pain during 6, 12, and 18 months. • Mean change in disability and quality of life: o as assessed by the Roland Disability Questionnaire from baseline to the following timepoints: 3, 6, 12, and 18 months. o as measured by the European Foundation for Osteoporosis Quality of Life Instrument (QUALEFFO) from baseline to the following timepoints: 6, 12, and 18 months. • Adverse events. ;Primary end point(s): Primary efficacy measure proportion of patients treated with daily teriparatide compared with weekly risedronate who have at least a 30% improvement in the 11-point numeric rating scale (0=no pain; 10=worst pain imaginable) evaluating back pain from baseline to Month 6. Back pain severity will be assessed using an 11-point numeric rating scale to rate the worst back pain experienced in the preceding 24 hours, completed daily by patients during the week prior to each scheduled study visit. These scores will be recorded in a 7-day diary. | — |
Countries
Belgium, Germany, Italy, Spain, Sweden
Outcome results
None listed