µMRI of Therapeutic Intervention in Postmenopausal Osteoporosis

NCT ID: NCT01153425

Last Updated: 2017-08-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-07-31
• Study Completion Date: 2012-12-31

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.

Conditions

Osteoporosis, Osteopenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Virtual Bone Biopsy

Intervention Type: OTHER

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.

Teriparatide

Intervention Type: DRUG

Participants are clinically indicated for treatment.

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.

Group Type: ACTIVE_COMPARATOR

Virtual Bone Biopsy

Intervention Type: OTHER

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.

Zoledronic Acid

Intervention Type: DRUG

Participants are clinically indicated for treatment.

Interventions

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.

Intervention Type: OTHER

Teriparatide

Participants are clinically indicated for treatment.

Intervention Type: DRUG

Zoledronic Acid

Participants are clinically indicated for treatment.

Intervention Type: DRUG

Other Intervention Names

VBB; Forteo; 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

• Minimum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: collaborator

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

NIH

Sponsor Role: collaborator

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Felix W. Wehrli, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania, Department of Radiology

Peter J. Snyder, M.D.

Role: STUDY_DIRECTOR

University Of Pennsylvania, Department of Endocrinology

Locations

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

R01AR041443

Identifier Type: NIH

Identifier Source: secondary_id

View Link

803763

Identifier Type: -

Identifier Source: org_study_id