Phase 4
N=33
µMRI of Therapeutic Intervention in Postmenopausal Osteoporosis
Osteoporosis, Osteopenia
Bottom Line
View on ClinicalTrials.gov: NCT01153425 ↗Enrolled (actual)
33
Serious AEs
3.0%
Results posted
Aug 2017
Primary outcome: Primary: Percentage of Change in Trabecular Surface-to-curve Ratio — 9.1; 7.1 Percentage of Change
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Virtual Bone Biopsy (Other); Teriparatide (Drug); Zoledronic Acid (Drug)
- Age
- Adult, Older Adult · 60+ yrs
- Sex
- Female
- Sponsor
- University of Pennsylvania
- Primary completion
- Dec 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Change in Trabecular Surface-to-curve Ratio |
9.1; 7.1 | — |
| SECONDARY Percentage of Change in Bone Volume Fraction (BVF) |
1.0; 0.6 | >0.05 |
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.
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 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
Data sourced from ClinicalTrials.gov (NCT01153425). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.