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µMRI of Therapeutic Intervention in Postmenopausal Osteoporosis (TERIZOL)

This study has been completed.
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
ClinicalTrials.gov Identifier:
NCT01153425
First received: June 1, 2009
Last updated: August 1, 2017
Last verified: August 2017
  Purpose
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.

Condition Intervention Phase
Osteoporosis, Osteopenia Other: Virtual Bone Biopsy Drug: Teriparatide Drug: Zoledronic Acid Phase 4

Study Type: Interventional
Study Design: 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
Official Title: NMR Imaging and Stereological Analysis of Trabecular Bone in Female Subjects 60 and Older at Risk of Fracture Receiving Either Zoledronic Acid or Teriparatide

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • Percentage of Change in Bone Volume Fraction (BVF) [ Time Frame: Change between baseline and 12 months ]
    Average fractional content of bone expressed in percent


Enrollment: 33
Study Start Date: July 2008
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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
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.
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: Zoledronic Acid
Participants are clinically indicated for treatment.
Other Name: Reclast

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.
  Eligibility

Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Postmenopausal women
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT01153425

Locations
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Eli Lilly and Company
Novartis Pharmaceuticals
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Investigators
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
  More Information

Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01153425     History of Changes
Other Study ID Numbers: 803763
R01AR041443 ( U.S. NIH Grant/Contract )
Study First Received: June 1, 2009
Results First Received: May 22, 2017
Last Updated: August 1, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by University of Pennsylvania:
Osteoporosis
Osteopenia
Fracture Risk
teriparatide or Forteo
zoledronic acid or Reclast

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Zoledronic acid
Diphosphonates
Teriparatide
Bone Density Conservation Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 21, 2017