OPTAMISE: Clinical Effectiveness of Teriparatide After Alendronate or Risedronate Therapy in Osteoporotic Postmenopausal Women

ELIGIBILITY CRITERIA include: Post-menopausal women who have used risedronate or alendronate continuously for at least 24 mos prior to enrollment Dosing regimens allowable are continuous (ie, 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 prior to enrollment into study Lumbar spine or total hip BMD T-score 1ess than or equal to -2.0 and >/= 1 prevalent osteoporotic fracture, or lumbar spine or total hip BMD T-score less than or equal to -2.5 with or without and >/= 1 prevalent osteoporotic fracture. The qualifying values must be documented prior to enrollment Vitamin D (25-hydroxyvitamin D) between 16 ng/ml and 80 ng/ml Urine NTX <50 nmol/mmol creatinine (to assure treatment compliance and bone turnover is in the pre-menopausal range) EXCLUSION CRITERIA include: Impaired renal function, demonstrated by creatinine clearance < 30 ml/min 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 (eg, confluent aortic calcifications, severe osteoarthritis, spinal fusion, lumbar spine fractures) 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 (ie, ibandronate, pamidronate, etidronate, raloxifene, clodronate, or zoledronate) Use of combination alendronate and risedronate, either simultaneously or sequentially, within 60 months prior to enrollment, or use of any anti-resorptive agent in combination with risedronate or alendronate