Status:
COMPLETED
OPTAMISE: Clinical Effectiveness of Teriparatide After Alendronate or Risedronate Therapy in Osteoporotic Postmenopausal Women
Lead Sponsor:
Sanofi
Collaborating Sponsors:
Procter and Gamble
Conditions:
Osteoporosis, Postmenopausal
Eligibility:
FEMALE
55-85 years
Phase:
PHASE4
Brief 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...
Detailed Description
All subjects will be treated with teriparatide (human, recombinant PTH\[1-34\])(human, recombinant PTH\[1-34\]), 20 microgram subcutaneously daily for 12 months. Subjects will consist of 290 postmenop...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2007
Estimated Enrollment :
290 Patients enrolled
Trial Details
Trial ID
NCT00130403
Start Date
March 1 2004
End Date
March 1 2007
Last Update
January 11 2011
Active Locations (7)
Enter a location and click search to find clinical trials sorted by distance.
1
sanofi-aventis, US
Bridgewater, New Jersey, United States, 08807
2
sanofi-aventis, Australia
Cove, New South Wales, Australia
3
sanofi-aventis, Belgium
Diegem, Belgium
4
sanofi-aventis, Canada
Laval, Quebec, Canada