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

This study has been completed.
Sponsor:
Collaborator:
Procter and Gamble
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00130403
First received: August 12, 2005
Last updated: January 10, 2011
Last verified: January 2011
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
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 ] [ Designated as safety issue: No ]

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 ] [ Designated as 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 ] [ Designated as 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 ] [ Designated as safety issue: No ]

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.

  Eligibility

Ages Eligible for Study:   55 Years to 85 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00130403

Locations
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
Belgium
sanofi-aventis, Belgium
Diegem, Belgium
Canada, Quebec
sanofi-aventis, Canada
Laval, Quebec, Canada
France
sanofi-aventis, France
Paris, France
Netherlands
sanofi-aventis, Netherlands
Gouda, Netherlands
United Kingdom
sanofi-aventi, UK
Guildford, Surrey, United Kingdom
Sponsors and Collaborators
Sanofi
Procter and Gamble
Investigators
Study Director: Suzanne Meeves, PharmD, MBA Sanofi
  More Information

No publications provided by Sanofi

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov 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
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Osteoporosis
Osteoporosis, Postmenopausal
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Risedronic acid
Alendronate
Etidronic Acid
Teriparatide
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 23, 2014