µMRI of Therapeutic Intervention in Postmenopausal Osteoporosis

• Status: Completed
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Pennsylvania
• Collaborators: Eli Lilly and Company; National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS); Novartis Pharmaceuticals
• Treatments: Diphosphonates; Teriparatide; Zoledronic Acid

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