Nuclear MRI(NMR)in Women at Risk of Fracture Receiving Either Zoledronic Acid or Teriparatide (TERIZOL)

This study has been completed.
Sponsor:
Collaborators:
Eli Lilly and Company
Novartis Pharmaceuticals
Information provided by (Responsible Party):
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01153425
First received: June 1, 2009
Last updated: January 31, 2013
Last verified: November 2011
  Purpose

The purpose of this study is to determine the changes in trabecular bone architecture in women 60 and older with high risk of fracture treated with either teriparatide or zoledronic acid.


Condition Intervention
Osteoporosis, Osteopenia
Radiation: Virtual Bone Biopsy by Magnetic Resonance Imaging

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
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:
  • The primary end point will be the surface/curve ratio, a composite topological parameter, of the distal tibia. [ Time Frame: yearly ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Other MRI parameters, such as the erosion index, trabecular thickness and bone volume fraction. [ Time Frame: yearly ] [ Designated as safety issue: No ]
  • Bone densitometry parameters, including bone density total spine, hip and hip regions. [ Time Frame: yearly ] [ Designated as safety issue: No ]
  • Markers of bone turnover. [ Time Frame: yearly ] [ Designated as safety issue: No ]

Enrollment: 34
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 24 months and an MRI ('Virtual Bone Biopsy') will be performed at 0, 12 and 24 months.
Radiation: Virtual Bone Biopsy by Magnetic Resonance Imaging
The MRI involves virtual bone biopsy technology currently being developed. This new technology is not commercially or elsewhere available. It allows generation of 3D images of considerably smaller voxel size than the previous technology by employing new pulse sequences and advanced interpolation techniques. The enhanced resolution will enable capturing subtle remodeling-induced changes, such as reversal of the fenestration caused by prior osteoclastic resorption cavities. It will also permit measurement of trabecular thickness with increased accuracy and precision. Advances have also been made toward superior registration of follow-up scans relative to the baseline scans. This, we project, provides improved reproducibility and thus increased statistical power.
Active Comparator: Zoledronic Acid (Reclast)
5 mg of zoledronic Acid will be administered intravenously at baseline and 12 months and an MRI ('Virtual Bone Biopsy) will be performed at 0, 12, and 24 months.
Radiation: Virtual Bone Biopsy by Magnetic Resonance Imaging
The MRI involves virtual bone biopsy technology currently being developed. This new technology is not commercially or elsewhere available. It allows generation of 3D images of considerably smaller voxel size than the previous technology by employing new pulse sequences and advanced interpolation techniques. The enhanced resolution will enable capturing subtle remodeling-induced changes, such as reversal of the fenestration caused by prior osteoclastic resorption cavities. It will also permit measurement of trabecular thickness with increased accuracy and precision. Advances have also been made toward superior registration of follow-up scans relative to the baseline scans. This, we project, provides improved reproducibility and thus increased statistical power.

Detailed Description:

The overall design is to determine and compare the effect of teriparatide and of zoledronic acid on trabecular architecture by magnetic resonance microimaging of the midshaft tibia. Fifty-six postmenopausal women, aged 60 or older with osteoporosis and/or at increased risk of fracture, will be randomized to receive either teriparatide or zoledronic acid. Both groups will be followed for 24 months. Trabecular microarchitecture, cortical structural parameters, biomechanical parameters and bone mineral density will be examined at 0, 12, and 24 months.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Female
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
Investigators
Principal Investigator: Felix W. Wehrli, Ph.D. University of Pennsylvania, Dept of Radiology
Principal Investigator: Peter J. Snyder, M.D. University Of Pennsylvania, Department of Endocrinology
  More Information

No publications provided

Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01153425     History of Changes
Other Study ID Numbers: 803763, RO1-AR41443
Study First Received: June 1, 2009
Last Updated: January 31, 2013
Health Authority: United States: University of Pennsylvania, Institutional Review Board

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
Teriparatide
Diphosphonates
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 19, 2014