Trial Outcomes & Findings for µMRI of Therapeutic Intervention in Postmenopausal Osteoporosis (NCT NCT01153425)
NCT ID: NCT01153425
Last Updated: 2017-08-04
Results Overview
Ratio of the volume densities of surface (S) and curve (C)-type voxels, S/C
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
33 participants
Primary outcome timeframe
Change between baseline and 12 months
Results posted on
2017-08-04
Participant Flow
Participants were recruited from the Philadelphia region via various modes of public advertisements (radio, newspapers, flyers).
To qualify for participation participants must have BMD T-scores of either the spine (L1-L4) or total hip of ≤ -2.5 or a history of osteoporotic fracture.
Participant milestones
| Measure |
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 by Magnetic Resonance Imaging: The MRI involves virtual bone biopsy technology currently being developed. This new technology is not commercially or elsewhere available. It allows generation of 3D images of considerably smaller voxel size than the previous technology by employing new pulse sequences and advanced interpolation techniques. The enhanced resolution will enable capturing subtle remodeling-induced changes, such as reversal of the fenestration caused by prior osteoclastic resorption cavities. It will also permit measurement of trabecular thickness with increased accuracy and precision. Advances have also been made toward superior registration of follow-up scans relative to the baseline scans. This, we project, provides improved reproducibility and thus increased statistical power.
|
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 by Magnetic Resonance Imaging: The MRI involves virtual bone biopsy technology currently being developed. This new technology is not commercially or elsewhere available. It allows generation of 3D images of considerably smaller voxel size than the previous technology by employing new pulse sequences and advanced interpolation techniques. The enhanced resolution will enable capturing subtle remodeling-induced changes, such as reversal of the fenestration caused by prior osteoclastic resorption cavities. It will also permit measurement of trabecular thickness with increased accuracy and precision. Advances have also been made toward superior registration of follow-up scans relative to the baseline scans. This, we project, provides improved reproducibility and thus increased statistical power.
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
17
|
|
Overall Study
COMPLETED
|
13
|
14
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
Reasons for withdrawal
| Measure |
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 by Magnetic Resonance Imaging: The MRI involves virtual bone biopsy technology currently being developed. This new technology is not commercially or elsewhere available. It allows generation of 3D images of considerably smaller voxel size than the previous technology by employing new pulse sequences and advanced interpolation techniques. The enhanced resolution will enable capturing subtle remodeling-induced changes, such as reversal of the fenestration caused by prior osteoclastic resorption cavities. It will also permit measurement of trabecular thickness with increased accuracy and precision. Advances have also been made toward superior registration of follow-up scans relative to the baseline scans. This, we project, provides improved reproducibility and thus increased statistical power.
|
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 by Magnetic Resonance Imaging: The MRI involves virtual bone biopsy technology currently being developed. This new technology is not commercially or elsewhere available. It allows generation of 3D images of considerably smaller voxel size than the previous technology by employing new pulse sequences and advanced interpolation techniques. The enhanced resolution will enable capturing subtle remodeling-induced changes, such as reversal of the fenestration caused by prior osteoclastic resorption cavities. It will also permit measurement of trabecular thickness with increased accuracy and precision. Advances have also been made toward superior registration of follow-up scans relative to the baseline scans. This, we project, provides improved reproducibility and thus increased statistical power.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
3
|
Baseline Characteristics
µMRI of Therapeutic Intervention in Postmenopausal Osteoporosis
Baseline characteristics by cohort
| Measure |
Teriparatide (Forteo)
n=16 Participants
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 by Magnetic Resonance Imaging: The MRI involves virtual bone biopsy technology currently being developed. This new technology is not commercially or elsewhere available. It allows generation of 3D images of considerably smaller voxel size than the previous technology by employing new pulse sequences and advanced interpolation techniques. The enhanced resolution will enable capturing subtle remodeling-induced changes, such as reversal of the fenestration caused by prior osteoclastic resorption cavities. It will also permit measurement of trabecular thickness with increased accuracy and precision. Advances have also been made toward superior registration of follow-up scans relative to the baseline scans. This, we project, provides improved reproducibility and thus increased statistical power.
|
Zoledronic Acid (Reclast)
n=17 Participants
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 by Magnetic Resonance Imaging: The MRI involves virtual bone biopsy technology currently being developed. This new technology is not commercially or elsewhere available. It allows generation of 3D images of considerably smaller voxel size than the previous technology by employing new pulse sequences and advanced interpolation techniques. The enhanced resolution will enable capturing subtle remodeling-induced changes, such as reversal of the fenestration caused by prior osteoclastic resorption cavities. It will also permit measurement of trabecular thickness with increased accuracy and precision. Advances have also been made toward superior registration of follow-up scans relative to the baseline scans. This, we project, provides improved reproducibility and thus increased statistical power.
|
Total
n=33 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
69.55 years
n=5 Participants
|
66.22 years
n=7 Participants
|
67.94 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Change between baseline and 12 monthsPopulation: Mean change in structural and mechanical markers of bone turnover between the two groups.
Ratio of the volume densities of surface (S) and curve (C)-type voxels, S/C
Outcome measures
| Measure |
Teriparatide (Forteo)
n=13 Participants
20 µg of Teriparatide self-injected subcutaneously once a day for 24 months with MRI performed at 0, 12 and 24 months.
The data showed strong increases in finite element derived axial stiffness and improvement in structural parameters indicative of a more connected, more plate-like topology at the 12 and 24-month time points: bone marrow density (BMD), bone volume fraction (BVF), the topological parameters surface-to-curve ratio (S/C), which is a measure of the bone's "platelikeness", erosion index (EI), a parameter expressing the loss of connectivity, and axial stiffness (Ezz), all changed in the direction suggesting an improvement of bone quality.
No difference was detected between the two treatment arms.
|
Zoledronic Acid (Reclast)
n=14 Participants
5 mg of zoledronic Acid administered intravenously at baseline and 12 months and MRI performed at 0, 12, and 24 months.
The data showed strong increases in finite element derived axial stiffness and improvement in structural parameters indicative of a more connected, more plate-like topology at the 12 and 24-month time points: bone marrow density (BMD), bone volume fraction (BVF), the topological parameters surface-to-curve ratio (S/C), which is a measure of the bone's "platelikeness", erosion index (EI), a parameter expressing the loss of connectivity, and axial stiffness (Ezz), all changed in the direction suggesting an improvement of bone quality.
No difference was detected between the two treatment arms.
|
|---|---|---|
|
Percentage of Change in Trabecular Surface-to-curve Ratio
|
9.1 Percentage of Change
Standard Deviation 2.0
|
7.1 Percentage of Change
Standard Deviation 2.6
|
SECONDARY outcome
Timeframe: Change between baseline and 12 monthsAverage fractional content of bone expressed in percent
Outcome measures
| Measure |
Teriparatide (Forteo)
n=13 Participants
20 µg of Teriparatide self-injected subcutaneously once a day for 24 months with MRI performed at 0, 12 and 24 months.
The data showed strong increases in finite element derived axial stiffness and improvement in structural parameters indicative of a more connected, more plate-like topology at the 12 and 24-month time points: bone marrow density (BMD), bone volume fraction (BVF), the topological parameters surface-to-curve ratio (S/C), which is a measure of the bone's "platelikeness", erosion index (EI), a parameter expressing the loss of connectivity, and axial stiffness (Ezz), all changed in the direction suggesting an improvement of bone quality.
No difference was detected between the two treatment arms.
|
Zoledronic Acid (Reclast)
n=14 Participants
5 mg of zoledronic Acid administered intravenously at baseline and 12 months and MRI performed at 0, 12, and 24 months.
The data showed strong increases in finite element derived axial stiffness and improvement in structural parameters indicative of a more connected, more plate-like topology at the 12 and 24-month time points: bone marrow density (BMD), bone volume fraction (BVF), the topological parameters surface-to-curve ratio (S/C), which is a measure of the bone's "platelikeness", erosion index (EI), a parameter expressing the loss of connectivity, and axial stiffness (Ezz), all changed in the direction suggesting an improvement of bone quality.
No difference was detected between the two treatment arms.
|
|---|---|---|
|
Percentage of Change in Bone Volume Fraction (BVF)
|
1.0 Percentage of Change
Standard Deviation 0.8
|
0.6 Percentage of Change
Standard Deviation 0.3
|
Adverse Events
Teriparatide (Forteo)
Serious events: 1 serious events
Other events: 15 other events
Deaths: 0 deaths
Zoledronic Acid (Reclast)
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Teriparatide (Forteo)
n=16 participants at risk
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.
|
Zoledronic Acid (Reclast)
n=17 participants at risk
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.
|
|---|---|---|
|
Surgical and medical procedures
Serious
|
6.2%
1/16 • Number of events 1 • 2 years
Adverse events were monitored/assessed without regard to the specific adverse event term. Please note that adverse events do include abnormal laboratory values at screening.
|
0.00%
0/17 • 2 years
Adverse events were monitored/assessed without regard to the specific adverse event term. Please note that adverse events do include abnormal laboratory values at screening.
|
Other adverse events
| Measure |
Teriparatide (Forteo)
n=16 participants at risk
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.
|
Zoledronic Acid (Reclast)
n=17 participants at risk
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.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Moderate
|
6.2%
1/16 • Number of events 1 • 2 years
Adverse events were monitored/assessed without regard to the specific adverse event term. Please note that adverse events do include abnormal laboratory values at screening.
|
5.9%
1/17 • Number of events 1 • 2 years
Adverse events were monitored/assessed without regard to the specific adverse event term. Please note that adverse events do include abnormal laboratory values at screening.
|
|
Surgical and medical procedures
Moderate
|
6.2%
1/16 • Number of events 1 • 2 years
Adverse events were monitored/assessed without regard to the specific adverse event term. Please note that adverse events do include abnormal laboratory values at screening.
|
5.9%
1/17 • Number of events 1 • 2 years
Adverse events were monitored/assessed without regard to the specific adverse event term. Please note that adverse events do include abnormal laboratory values at screening.
|
|
Blood and lymphatic system disorders
Mild
|
43.8%
7/16 • Number of events 9 • 2 years
Adverse events were monitored/assessed without regard to the specific adverse event term. Please note that adverse events do include abnormal laboratory values at screening.
|
35.3%
6/17 • Number of events 12 • 2 years
Adverse events were monitored/assessed without regard to the specific adverse event term. Please note that adverse events do include abnormal laboratory values at screening.
|
|
Respiratory, thoracic and mediastinal disorders
Mild
|
6.2%
1/16 • Number of events 1 • 2 years
Adverse events were monitored/assessed without regard to the specific adverse event term. Please note that adverse events do include abnormal laboratory values at screening.
|
5.9%
1/17 • Number of events 1 • 2 years
Adverse events were monitored/assessed without regard to the specific adverse event term. Please note that adverse events do include abnormal laboratory values at screening.
|
|
General disorders
Mild
|
56.2%
9/16 • Number of events 11 • 2 years
Adverse events were monitored/assessed without regard to the specific adverse event term. Please note that adverse events do include abnormal laboratory values at screening.
|
23.5%
4/17 • Number of events 4 • 2 years
Adverse events were monitored/assessed without regard to the specific adverse event term. Please note that adverse events do include abnormal laboratory values at screening.
|
|
Eye disorders
Mild
|
0.00%
0/16 • 2 years
Adverse events were monitored/assessed without regard to the specific adverse event term. Please note that adverse events do include abnormal laboratory values at screening.
|
5.9%
1/17 • Number of events 1 • 2 years
Adverse events were monitored/assessed without regard to the specific adverse event term. Please note that adverse events do include abnormal laboratory values at screening.
|
|
Gastrointestinal disorders
Moderate
|
0.00%
0/16 • 2 years
Adverse events were monitored/assessed without regard to the specific adverse event term. Please note that adverse events do include abnormal laboratory values at screening.
|
5.9%
1/17 • Number of events 1 • 2 years
Adverse events were monitored/assessed without regard to the specific adverse event term. Please note that adverse events do include abnormal laboratory values at screening.
|
|
General disorders
Moderate
|
0.00%
0/16 • 2 years
Adverse events were monitored/assessed without regard to the specific adverse event term. Please note that adverse events do include abnormal laboratory values at screening.
|
11.8%
2/17 • Number of events 2 • 2 years
Adverse events were monitored/assessed without regard to the specific adverse event term. Please note that adverse events do include abnormal laboratory values at screening.
|
|
Blood and lymphatic system disorders
Moderate
|
12.5%
2/16 • Number of events 3 • 2 years
Adverse events were monitored/assessed without regard to the specific adverse event term. Please note that adverse events do include abnormal laboratory values at screening.
|
0.00%
0/17 • 2 years
Adverse events were monitored/assessed without regard to the specific adverse event term. Please note that adverse events do include abnormal laboratory values at screening.
|
|
Eye disorders
Moderate
|
6.2%
1/16 • Number of events 1 • 2 years
Adverse events were monitored/assessed without regard to the specific adverse event term. Please note that adverse events do include abnormal laboratory values at screening.
|
0.00%
0/17 • 2 years
Adverse events were monitored/assessed without regard to the specific adverse event term. Please note that adverse events do include abnormal laboratory values at screening.
|
Additional Information
Felix W. Wehrli, Ph.D.
University of Pennsylvania, Perelman School of Medicine
Phone: 215-662-7951
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place