Back to resultsµMRI of Therapeutic Intervention in Postmenopausal Osteoporosis (TERIZOL)
Primary Purpose
Osteoporosis, Osteopenia
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Virtual Bone Biopsy
Teriparatide
Zoledronic Acid
Sponsored by
About this trial
This is an interventional treatment trial for Osteoporosis, Osteopenia focused on measuring Osteoporosis, Osteopenia, Fracture Risk, teriparatide or Forteo, zoledronic acid or Reclast
Eligibility 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
Sites / Locations
- University of Pennsylvania
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Teriparatide (Forteo)
Zoledronic Acid (Reclast)
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Percentage of Change in Trabecular Surface-to-curve Ratio
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)
Average fractional content of bone expressed in percent
Full Information
NCT ID
NCT01153425
First Posted
June 1, 2009
Last Updated
August 1, 2017
Sponsor
University of Pennsylvania
Collaborators
Eli Lilly and Company, Novartis Pharmaceuticals, National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
1. Study Identification
Unique Protocol Identification Number
NCT01153425
Brief Title
µMRI of Therapeutic Intervention in Postmenopausal Osteoporosis
Acronym
TERIZOL
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania
Collaborators
Eli Lilly and Company, Novartis Pharmaceuticals, National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis, Osteopenia
Keywords
Osteoporosis, Osteopenia, Fracture Risk, teriparatide or Forteo, zoledronic acid or Reclast
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Teriparatide (Forteo)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Zoledronic Acid (Reclast)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Virtual Bone Biopsy
Other Intervention Name(s)
VBB
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Teriparatide
Other Intervention Name(s)
Forteo
Intervention Description
Participants are clinically indicated for treatment.
Intervention Type
Drug
Intervention Name(s)
Zoledronic Acid
Other Intervention Name(s)
Reclast
Intervention Description
Participants are clinically indicated for treatment.
Primary Outcome Measure Information:
Title
Percentage of Change in Trabecular Surface-to-curve Ratio
Description
Ratio of the volume densities of surface (S) and curve (C)-type voxels, S/C
Time Frame
Change between baseline and 12 months
Secondary Outcome Measure Information:
Title
Percentage of Change in Bone Volume Fraction (BVF)
Description
Average fractional content of bone expressed in percent
Time Frame
Change between baseline and 12 months
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Postmenopausal women
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Felix W. Wehrli, Ph.D.
Organizational Affiliation
University of Pennsylvania, Department of Radiology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Peter J. Snyder, M.D.
Organizational Affiliation
University Of Pennsylvania, Department of Endocrinology
Official's Role
Study Director
Facility Information:
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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µMRI of Therapeutic Intervention in Postmenopausal Osteoporosis
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