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µMRI of Therapeutic Intervention in Postmenopausal Osteoporosis (TERIZOL)

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ClinicalTrials.gov Identifier: NCT01153425
Recruitment Status : Completed
First Posted : June 30, 2010
Results First Posted : August 4, 2017
Last Update Posted : August 4, 2017
Sponsor:
Collaborators:
Eli Lilly and Company
Novartis Pharmaceuticals
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by (Responsible Party):
University of Pennsylvania

Tracking Information
First Submitted Date  ICMJE June 1, 2009
First Posted Date  ICMJE June 30, 2010
Results First Submitted Date  ICMJE May 22, 2017
Results First Posted Date  ICMJE August 4, 2017
Last Update Posted Date August 4, 2017
Study Start Date  ICMJE July 2008
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 1, 2017)
Percentage of Change in Trabecular Surface-to-curve Ratio [ Time Frame: Change between baseline and 12 months ]
Ratio of the volume densities of surface (S) and curve (C)-type voxels, S/C
Original Primary Outcome Measures  ICMJE
 (submitted: June 28, 2010)
The primary end point will be the surface/curve ratio, a composite topological parameter, of the distal tibia. [ Time Frame: yearly ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 1, 2017)
Percentage of Change in Bone Volume Fraction (BVF) [ Time Frame: Change between baseline and 12 months ]
Average fractional content of bone expressed in percent
Original Secondary Outcome Measures  ICMJE
 (submitted: June 28, 2010)
  • Other MRI parameters, such as the erosion index, trabecular thickness and bone volume fraction. [ Time Frame: yearly ]
  • Bone densitometry parameters, including bone density total spine, hip and hip regions. [ Time Frame: yearly ]
  • Markers of bone turnover. [ Time Frame: yearly ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE µMRI of Therapeutic Intervention in Postmenopausal Osteoporosis
Official Title  ICMJE NMR Imaging and Stereological Analysis of Trabecular Bone in Female Subjects 60 and Older at Risk of Fracture Receiving Either Zoledronic Acid or Teriparatide
Brief Summary The purpose of this study is to apply a novel advanced magnetic resonance imaging methodology to evaluate the response to drug intervention involving two treatment arms of postmenopausal participants with osteoporosis, randomized into either a teriparatide (Forteo™) or zoledronic acid (Reclast™) group.
Detailed Description The overall design is to determine and compare the effect of teriparatide and of zoledronic acid on trabecular architecture by magnetic resonance imaging of the midshaft tibia. Post-menopausal women, aged 60 or older with osteoporosis and/or at increased risk of fracture, will be randomized to receive either teriparatide or zoledronic acid. Trabecular microarchitecture, biomechanical parameters and bone mineral density will be examined at 0 and 12 months at 3T MRI.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Postmenopausal women, ages ≥ 60 years, indicated for treatment with antiresorptive or anabolic drugs due to severe osteoporosis and high risk of fracture.
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Osteoporosis, Osteopenia
Intervention  ICMJE
  • Other: Virtual Bone Biopsy
    MRI technology allowing generation of 3D images with considerably smaller voxel size than previous technology through the use of novel pulse sequences and advanced interpolation techniques.
    Other Name: VBB
  • Drug: Teriparatide
    Participants are clinically indicated for treatment.
    Other Name: Forteo
  • Drug: Zoledronic Acid
    Participants are clinically indicated for treatment.
    Other Name: Reclast
Study Arms  ICMJE
  • Active Comparator: Teriparatide (Forteo)
    20 µg of Teriparatide will be self-injected subcutaneously once a day for 12 months and an MRI at 3T ('Virtual Bone Biopsy') will be performed at 0 and 12 months.
    Interventions:
    • Other: Virtual Bone Biopsy
    • Drug: Teriparatide
  • Active Comparator: Zoledronic Acid (Reclast)
    5 mg of zoledronic Acid will be administered intravenously at baseline and 12 months and an MRI at 3T ('Virtual Bone Biopsy) will be performed at 0 and 12 months.
    Interventions:
    • Other: Virtual Bone Biopsy
    • Drug: Zoledronic Acid
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 1, 2017)
33
Original Estimated Enrollment  ICMJE
 (submitted: June 28, 2010)
56
Actual Study Completion Date  ICMJE December 2012
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Women
  • Age ≥ 60 years
  • Bone mineral density T-score of either the spine (L1-L4), total hip or femoral neck of ≤ - 2.0, or has a history of an osteoporotic fracture

Exclusion Criteria:

  • Previous treatment with pamidronate, ibandronate, of more than 2 doses in 2 years and of zoledronic acid at any time
  • Previous treatment with teriparatide, alendronate or risedronate of more than 2 months in the last 24 months
  • Previous treatment with calcitonin within the previous year; previous treatment with an estrogen or selective estrogen modulator will not exclude a potential subject unless she has been taking it for < 1 year (a woman who discontinued estrogen or a selective estrogen receptor within the previous year will also be excluded)
  • Other diseases known to affect bone, such as Paget's disease, Cushing's disease, hyperthyroidism, hyperparathyroidism, bone cancer and metastases to bone, and vitamin D deficiency
  • Medications known to affect bone, such as anticonvulsants, high dose glucocorticoids (20 mg/day or more > 2 weeks within the previous 6 months)
  • Current alcohol use > 3 drinks/day
  • Untreated or unstable cardiac, pulmonary, liver (SGOT > 2X upper limit of normal) or renal disease (creatinine > 1.2 mg/dL) or uncontrolled diabetes (hemoglobin A1C > 8.0)
  • Prior radiation therapy to the skeleton
  • Cardiac pacemakers, ferromagnetic implants or brain aneurysm clips
  • Claustrophobia
  • Subjects whose initial MRI is of poor quality due to motion artifact will be asked to repeat the examination; if a repeat MRI is of poor quality due to motion artifact, the subject will be excluded from the study
  • Abnormalities of the which delay esophageal emptying such as stricture or achalasia
  • Inability to stand or sit upright for at least 30 minutes
  • Hypocalcemia
  • Uric acid level >7.5ml/dl
  • Subjects with metallic objects in their bodies
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: Postmenopausal women
Ages  ICMJE 60 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01153425
Other Study ID Numbers  ICMJE 803763
R01AR041443 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of Pennsylvania
Study Sponsor  ICMJE University of Pennsylvania
Collaborators  ICMJE
  • Eli Lilly and Company
  • Novartis Pharmaceuticals
  • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Investigators  ICMJE
Principal Investigator: Felix W. Wehrli, Ph.D. University of Pennsylvania, Department of Radiology
Study Director: Peter J. Snyder, M.D. University Of Pennsylvania, Department of Endocrinology
PRS Account University of Pennsylvania
Verification Date August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP