µMRI of Therapeutic Intervention in Postmenopausal Osteoporosis

Osteoporosis, Osteopenia Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01153425
• Other study ID #: 803763
• Secondary ID: R01AR041443
• Status: Completed
• Phase: Phase 4
• First received: June 1, 2009
• Last updated: August 1, 2017
• Start date: July 2008
• Est. completion date: December 2012

Study information

• Verified date: August 2017
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bone Diseases, Metabolic
• Osteoporosis
• Osteoporosis, Osteopenia

Intervention

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.

Drug:
• Teriparatide
Participants are clinically indicated for treatment.
• Zoledronic Acid
Participants are clinically indicated for treatment.

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (4)

Lead Sponsor	Collaborator
University of Pennsylvania	Eli Lilly and Company, National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Change in Trabecular Surface-to-curve Ratio	Ratio of the volume densities of surface (S) and curve (C)-type voxels, S/C	Change between baseline and 12 months
Secondary	Percentage of Change in Bone Volume Fraction (BVF)	Average fractional content of bone expressed in percent	Change between baseline and 12 months