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

This study has been completed.
Procter and Gamble
Information provided by:
Sanofi Identifier:
First received: August 12, 2005
Last updated: January 10, 2011
Last verified: January 2011
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 Intervention Phase
Osteoporosis, Postmenopausal Drug: risedronate sodium Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by Sanofi:

Primary Outcome 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 ]

Secondary Outcome 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 ]
  • 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 ]
  • 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 ]

Enrollment: 290
Study Start Date: March 2004
Study Completion Date: March 2007
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.

Ages Eligible for Study:   55 Years to 85 Years   (Adult, Senior)
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
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Please refer to this study by its identifier: NCT00130403

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
Study Director: Suzanne Meeves, PharmD, MBA Sanofi
  More Information

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00130403     History of Changes
Other Study ID Numbers: HMR4003B_4034
EudraCT # :2004-002317-37
Study First Received: August 12, 2005
Last Updated: January 10, 2011

Additional relevant MeSH terms:
Osteoporosis, Postmenopausal
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Risedronate Sodium
Etidronic Acid
Bone Density Conservation Agents
Physiological Effects of Drugs
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action processed this record on June 22, 2017