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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00130403
Recruitment Status : Completed
First Posted : August 15, 2005
Last Update Posted : January 11, 2011
Procter and Gamble
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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 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.

Condition or disease Intervention/treatment Phase
Osteoporosis, Postmenopausal Drug: risedronate sodium Phase 4

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 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 290 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : March 2004
Actual Study Completion Date : March 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoporosis

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • 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)


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00130403

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United States, New Jersey
sanofi-aventis, US
Bridgewater, New Jersey, United States, 08807
Australia, New South Wales
sanofi-aventis, Australia
Cove, New South Wales, Australia
sanofi-aventis, Belgium
Diegem, Belgium
Canada, Quebec
sanofi-aventis, Canada
Laval, Quebec, Canada
sanofi-aventis, France
Paris, France
sanofi-aventis, Netherlands
Gouda, Netherlands
United Kingdom
sanofi-aventi, UK
Guildford, Surrey, United Kingdom
Sponsors and Collaborators
Procter and Gamble
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Study Director: Suzanne Meeves, PharmD, MBA Sanofi
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00130403    
Other Study ID Numbers: HMR4003B_4034
EudraCT # :2004-002317-37
First Posted: August 15, 2005    Key Record Dates
Last Update Posted: January 11, 2011
Last Verified: January 2011
Additional relevant MeSH terms:
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Osteoporosis, Postmenopausal
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Risedronic Acid
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Bone Density Conservation Agents