Post-menopausal woman with 1 or more prevalent osteoporotic fractures and a BMD (spine or hip) of < -2.5 (see protocol amendment 2). MedDRA version: 7.0 Level: LLT Classification code 10031285
Conditions
Interventions
Trade Name: Forsteo 20 micrograms/ 80 microlitres, solution for injection, in pre-filled pen
Product Name: Teriparatide (human, recombinant PTH [1-34])
Product Code: not applicable
Pharmaceutical Form
Sponsors
Aventis Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: > Woman who have used risedronate or alendronate continuously for a minimum of 24 to 36 months up to enrollment into study. > Women who are at least 10 years post menopause (i.e., 10 years have elapsed since the last menstrual period). > 55-85 years of age (inclusive), if natural menopause, or 60-85 years of age (inclusive), if surgical menopause. > Must have appropriate documentation to confirm that subject has been on either continuous (i.e., uninterrupted) daily or weekly formulations of risedronate (5 mg once daily [OD] or 35 or 30 mg once a week [OAW]) or alendronate (10 mg OD or 70 mg OAW), for a minimum of 24 months up to enrollment into study. > LS or total hip BMD T-score less than or equal to -2.0 and a prevalent vertebral fracture, or LS or total hip BMD T-score less than or equal to -2.5. The qualifying values must have been documented prior to enrollment (amendment 2: LS or total hip BMD T-score less than -2.5 and a prevalent osteoporotic fracture). > Vitamin D replete (25-hydroxyvitamin more than or equal to 20 ng/ml and less than or equal to 80 ng/ml). > Urine NTX At least 2 measurable lumbar spine vertebrae (i.e., without fracture or sufficient degenerative disease) in which bone density assessment can be made without interfere. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: > Clinically relevant cardiovascular, hepatic, neurologic, endocrine, or other major systemic disease making implementation of the protocol or interpretation of the study results difficult. > Any previous or ongoing illness that, in the opinion of the investigator, could prevent the subject from completing the study. > Impaired renal function, as shown by creatinine clearance of less than 30 ml/min. > Subjects with active or recent urolithiasis (within 5 years of the time of enrollment). > Any condition or disease that may interfere with the evaluation of at least 2 lumbar vertebrae (not necessarily contiguous), determined in a screening radiograph by a radiologist at the central facility (e.g., confluent aortic calcifications, severe osteoarthritis, spinal fusion, lumbar spine fractures). > History of untreated osteomalacia. > History of osteosarcoma. > Any condition that could predispose to the risk of osteosarcoma, including but not limited to Paget’s disease of bone, history of radiation therapy to the skeleton, or any metastatic skeletal disease. > History of cancer within the past 5 years, though subjects with a more recent history of relatively benign skin malignancies such as basal cell or squamous cell carcinoma are not excluded. Subjects with a more recent history of successfully treated cervical carcinoma in situ will not be excluded provided there is documented 12-month remission. > History of untreated hyperparathyroidism. > Uncorrected hypothyroidism or hyperthyroidism, as determined by clinical signs and symptoms and/or significantly abnormal lab values at screening. Although thyroid function studies are not required, should an abnormal TSH be detected, the subject may be enrolled, after consultation with the medical monitor, if other thyroid function tests are not significantly out of range and clinical manifestations of disease are not present. Subjects taking thyroid medication should be stabilized on an appropriate medication for 3 months prior to randomization. > Any abnormal laboratory parameters that are judged to be clinically significant. > History of unexplained elevated levels of alkaline phosphatase in the blood. > Hypocalcemia or hypercalcemia from any cause. > Depot injection Vitamin D >10,000 IU in the past 9 months prior to starting the investigational product. > Treatment with antiresorptive agents other than risedronate, alendronate, and hormone replacement therapy within the last 36 months before study entry (i.e., ibandronate, pamidronate, etidronate, raloxifene, clodronate, or zoledronate). > Use of any of the following medications within 6 months of starting the investigational product or any of the following medications for more than 14 days, within 1 year prior to starting the investigational product: - fluoride (more than or equal to 10 mg/day) - subcutaneous estrogen implant - hormone replacement therapy (estrogen and/or progesterin) - Estrogen (oral or skin patch) or estrogen-related drugs (e.g., tamoxifen, tibolone), except for low dose vaginal creams (less than or equal to 0.2 mg/day 17-ß estradiol or less than or equal to 1.5 mg/day estropipate) - Progestogen > Use of any of the following medications within 3 months of starting the investigational product or any of the following medications for more than 1 month, within 6 months prior to starting the investigational product: - Oral or parenteral glucocorticoids (more than or equal to 5 mg prednisone or equivalent/day) - Anabolic ste
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to compare the teriparatide (human, recombinant PTH[1-34])-associated change from baseline in P1NP, after 3 months of treatment, between subjects previously treated with risedronate and those previously treated with alendronate.;Secondary Objective: Compare the teriparatide-associated change from baseline in P1NP, at additional time points, Compare the teriparatide-associated change from baseline in other markers of bone formation, Compare the teriparatide-associated change from baseline in markers of bone resorption. Compare the teriparatide-associated percent change from baseline in LS BMD as measured by DXA, Compare the teriparatide-associated percent change from baseline in total hip BMD as measured by DXA, Compare the teriparatide-associated percent change from baseline in forearm BMD as measured by DXA, between subjects previously treated with risedronate and those previously treated with alendronate. ;Primary end point(s): Change from baseline in P1NP between the subjects previously treated with risedronate and the subjects previously treated with alendronate. | — |
Countries
Germany
Outcome results
None listed