Percentage of Change in Trabecular Surface-to-curve Ratio
| Group | Value (Percentage of Change) | Spread |
|---|---|---|
| Teriparatide (Forteo) | 9.1 | 2.0 |
| Zoledronic Acid (Reclast) | 7.1 | 2.6 |
Trial · Interventional
CompletedPhase 4Results postedRegistry dataShort name TERIZOL
United States
1 trial · 1 completed · 1 with posted results
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Active comparator
Teriparatide (Forteo)
20 µg of Teriparatide will be self-injected subcutaneously once a day for 12 months and an MRI at 3T ('Virtual Bone Biopsy') will be performed at 0 and 12 months.
Active comparator
Zoledronic Acid (Reclast)
5 mg of zoledronic Acid will be administered intravenously at baseline and 12 months and an MRI at 3T ('Virtual Bone Biopsy) will be performed at 0 and 12 months.
Outcomes the sponsor listed as primary.
Percentage of Change in Trabecular Surface-to-curve Ratio
Time frame · Change between baseline and 12 months
Ratio of the volume densities of surface (S) and curve (C)-type voxels, S/C
Percentage of Change in Bone Volume Fraction (BVF)
Time frame · Change between baseline and 12 months
Average fractional content of bone expressed in percent
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (Percentage of Change) | Spread |
|---|---|---|
| Teriparatide (Forteo) | 9.1 | 2.0 |
| Zoledronic Acid (Reclast) | 7.1 | 2.6 |
| Group | Value (Percentage of Change) | Spread |
|---|---|---|
| Teriparatide (Forteo) | 1.0 | 0.8 |
| Zoledronic Acid (Reclast) | 0.6 | 0.3 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Teriparatide (Forteo)20 µg of teriparatide will be self-injected subcutaneously once a day for 24 months and an MRI ('Virtual Bone Biopsy') will be performed at 0 and 24 months. Virtual Bone Biopsy: MRI technology allowing generation of 3D images with considerably smaller voxel size than previous technology through the use of novel pulse sequences and advanced interpolation techniques. Teriparatide: Participants are clinically indicated for treatment. | 0 / 16 | 1 / 16 | 15 / 16 |
| Zoledronic Acid (Reclast)5 mg of zoledronic Acid will be administered intravenously at baseline and 12 months and an MRI ('Virtual Bone Biopsy) will be performed at 0 and 24 months. Virtual Bone Biopsy: MRI technology allowing generation of 3D images with considerably smaller voxel size than previous technology through the use of novel pulse sequences and advanced interpolation techniques. Zoledronic Acid: Participants are clinically indicated for treatment. | 0 / 17 | 0 / 17 | 12 / 17 |
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