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

• Status: Completed
• Trial end date: 2007-03-01
• Target enrollment: 0
• Participant gender: Female

Summary

To determine how prior therapy with alendronate or risedronate in postmenopausal women with osteoporosis influences the clinical effectiveness of teriparatide; The primary objective of the study is to compare the teriparatide (human, recombinant PTH[1-34])-associated change from baseline in a marker of bone formation, N-terminal propeptide of type I collagen (P1NP), between subjects previously treated with risedronate and those previously treated with alendronate.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Collaborator: Procter and Gamble
• Treatments: Alendronate; Etidronic Acid; Risedronate Sodium; Risedronic Acid; Teriparatide

Criteria

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