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

Information source: University of Pennsylvania
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Osteoporosis, Osteopenia

Intervention: Virtual Bone Biopsy by Magnetic Resonance Imaging (Radiation)

Phase: N/A

Status: Completed

Sponsored by: University of Pennsylvania

Official(s) and/or principal investigator(s):
Felix W. Wehrli, Ph.D., Principal Investigator, Affiliation: University of Pennsylvania, Dept of Radiology
Peter J. Snyder, M.D., Principal Investigator, Affiliation: University Of Pennsylvania, Department of Endocrinology

Summary

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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Primary outcome: The primary end point will be the surface/curve ratio, a composite topological parameter, of the distal tibia.

Secondary outcome:

Other MRI parameters, such as the erosion index, trabecular thickness and bone volume fraction.

Bone densitometry parameters, including bone density total spine, hip and hip regions.

Markers of bone turnover.

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

Minimum age: 60 Years. Maximum age: N/A. Gender(s): Female.

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

Locations and Contacts

University of Pennsylvania, Philadelphia, Pennsylvania 19104, United States
Additional Information

Starting date: July 2008
Last updated: January 31, 2013

Page last updated: August 20, 2015

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