Official Title: “Open-Label Study to Determine How Prior Therapy With Alendronate or Risedronate in Postmenopausal Women With Osteoporosis Influences the Clinical Effectiveness of Teriparatide”

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.

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study

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 postmenopausal women previously treated with either risedronate or alendronate for at least 24 months. An approximately equal number of subjects will have been previously treated with risedronate and alendronate, and the subjects will be balanced with regard to duration of previous treatment.

Intervention(s) in this Clinical Trial

• Drug: risedronate sodium

Primary Measures

• Compare the PTH-associated change from baseline at Month 3 of procollagen peptide P1NP, in subjects previously treated with Risedronate or Alendronate
  • Time Frame: at Month 3
    Safety Issue?: No

Secondary Measures

• Compare changes from baseline for subjects previously treated with Risedronate or Alendronate for: P1NP & other biomarkers including bone-specific alkaline phosphatase, osteocalcin, serum CTX, urine NTX
  • Time Frame: at 0.5, 1, 2, 3, 4, 5, 6, & 12 months of treatment
    Safety Issue?: No
• Compare changes from baseline for subjects previously treated with Risedronate or Alendronate for: Lumbar spine & hip BMD measured by DXA
  • Time Frame: after 6 & 12 months of treatment
    Safety Issue?: No
• Compare changes from baseline for subjects previously treated with Risedronate or Alendronate for: Bone quality parameters captured by central quantitative computed tomography (QCT)
  • Time Frame: after 12 months of treatment
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 55 Years

Maximum Age for this Clinical Trial: 85 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Sanofi-Aventis

Overall Clinical Trial Officials and Contacts

Suzanne Meeves, PharmD, MBA Study Director Sanofi-Aventis  

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00130403

Study ID Number: HMR4003B/4034

ClinicalTrials.gov Identifier: NCT00130403

Health Authority: United States: Institutional Review Board

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