µMRI of Therapeutic Intervention in Postmenopausal Osteoporosis (NCT01153425) | Clinical Trial Compass
CompletedPhase 4
µMRI of Therapeutic Intervention in Postmenopausal Osteoporosis
United States33 participantsStarted 2008-07
Plain-language 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 (Forteoâ„¢) or zoledronic acid (Reclastâ„¢) group.
Who can participate
Age range60 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 moti…
What they're measuring
1
Percentage of Change in Trabecular Surface-to-curve Ratio