Clinical trial NCT01153425: µMRI of Therapeutic Intervention in Postmenopausal Osteoporosis
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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Osteoporosis, Osteopenia
Keywords: Osteoporosis
Osteopenia
Fracture Risk
teriparatide or Forteo
zoledronic acid or Reclast
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Eli Lilly and Company
name: Novartis Pharmaceuticals
name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
First posted: 2010-06-30
Enrollment: 33
Sex: FEMALE
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Postmenopausal women, ages ≥ 60 years, indicated for treatment with antiresorptive or anabolic drugs due to severe osteoporosis and high risk of fracture.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Percentage of Change in Trabecular Surface-to-curve Ratio
timeFrame: Change between baseline and 12 months
Secondary outcomes:
measure: Percentage of Change in Bone Volume Fraction (BVF)
timeFrame: Change between baseline and 12 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania, Department of Radiology
name: Felix W. Wehrli, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University Of Pennsylvania, Department of Endocrinology
name: Peter J. Snyder, M.D.
role: STUDY_DIRECTOR
References: