Osteoporosis, OsteopeniaPhase 4TERIZOLNCT01153425
µMRI of Therapeutic Intervention in Postmenopausal Osteoporosis
A Phase 4 study testing Virtual Bone Biopsy, Teriparatide and Zoledronic Acid in people with Osteoporosis, Osteopenia, run by University of Pennsylvania at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older, women only
- Conditions the study is for
- Osteoporosis, Osteopenia
- What is being tested?
- Virtual Bone Biopsy, Teriparatide and Zoledronic Acid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2008to Dec 2012
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: NMR Imaging and Stereological Analysis of Trabecular Bone in Female Subjects 60 and Older at Risk of Fracture Receiving Either Zoledronic Acid or Teriparatide
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.
Read the detailed description
The overall design is to determine and compare the effect of teriparatide and of zoledronic acid on trabecular architecture by magnetic resonance imaging of the midshaft tibia. Post-menopausal women, aged 60 or older with osteoporosis and/or at increased risk of fracture, will be randomized to receive either teriparatide or zoledronic acid. Trabecular microarchitecture, biomechanical parameters and bone mineral density will be examined at 0 and 12 months at 3T MRI.
- Conditions
- Osteoporosis, Osteopenia
- Being tested
- Virtual Bone Biopsy, Teriparatide, Zoledronic Acid
- Keywords
- Osteoporosis, Osteopenia, Fracture Risk, teriparatide or Forteo, zoledronic acid or Reclast
- Medical subject headings
- Osteoporosis, Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Bone BiopsyOther
Also called VBB
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.
TeriparatideDrug
Also called Forteo
Participants are clinically indicated for treatment.
Zoledronic AcidDrug
Also called Reclast
Participants are clinically indicated for treatment.
| Study group | Role | What they receive |
|---|---|---|
| Teriparatide (Forteo) | Active comparator | 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. Receives: Other: Virtual Bone Biopsy; Drug: Teriparatide |
| Zoledronic Acid (Reclast) | Active comparator | 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. Receives: Other: Virtual Bone Biopsy; Drug: Zoledronic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Change in Trabecular Surface-to-curve Ratio
Ratio of the volume densities of surface (S) and curve (C)-type voxels, S/C
Measured: Change between baseline and 12 months
Secondary outcomes (1)
Percentage of Change in Bone Volume Fraction (BVF)
Average fractional content of bone expressed in percent
Measured: Change between baseline and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2010 (estimated)
- Study startJul 2008
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Osteoporosis, OsteopeniaStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Postmenopausal women, ages ≥ 60 years, indicated for treatment with antiresorptive or anabolic drugs due to severe osteoporosis and high risk of fracture.
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Eli Lilly and Company, Novartis Pharmaceuticals, National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Responsible party
- Sponsor
- Investigators
- Felix W. Wehrli, Ph.D., Principal investigator, University of Pennsylvania, Department of RadiologyPeter J. Snyder, M.D., Study director, University Of Pennsylvania, Department of Endocrinology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01153425
- Sponsor's protocol ID
- 803763
- Other IDs
- R01AR041443
- Acronym
- TERIZOL
- Status last verified
- Aug 2017
- First submitted
- 1 Jun 2009
- Last updated
- 4 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NMR Imaging and Stereological Analysis of Trabecular Bone in Female Subjects 60 and Older at Risk of Fracture Receiving Either Zoledronic Acid or Teriparatide
- ClinicalTrials.gov ID
- NCT01153425
- Acronym / sponsor ID
- TERIZOL / 803763
- Conditions
- Osteoporosis, Osteopenia
- Keywords
- Osteoporosis, Osteopenia, Fracture Risk, teriparatide or Forteo, zoledronic acid or Reclast
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Eli Lilly and Company, Novartis Pharmaceuticals, National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study start
- Jul 2008
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 30 Jun 2010 (estimated)
- Results
- Posted 4 Aug 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The overall design is to determine and compare the effect of teriparatide and of zoledronic acid on trabecular architecture by magnetic resonance imaging of the midshaft tibia. Post-menopausal women, aged 60 or older with osteoporosis and/or at increased risk of fracture, will be randomized to receive either teriparatide or zoledronic acid. Trabecular microarchitecture, biomechanical parameters and bone mineral density will be examined at 0 and 12 months at 3T MRI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Postmenopausal women, ages ≥ 60 years, indicated for treatment with antiresorptive or anabolic drugs due to severe osteoporosis and high risk of fracture.
| Arm | Type | Receives |
|---|---|---|
| Teriparatide (Forteo) | Active comparator | Other: Virtual Bone Biopsy, Drug: Teriparatide20 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. |
| Zoledronic Acid (Reclast) | Active comparator | Other: Virtual Bone Biopsy, Drug: Zoledronic Acid5 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (16 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Bone BiopsyAlso: VBBMRI 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. | Other | Teriparatide (Forteo), Zoledronic Acid (Reclast) |
| TeriparatideAlso: ForteoParticipants are clinically indicated for treatment. | Drug | Teriparatide (Forteo) |
| Zoledronic AcidAlso: ReclastParticipants are clinically indicated for treatment. | Drug | Zoledronic Acid (Reclast) |
Primary outcome
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
1 secondary outcome
Percentage of Change in Bone Volume Fraction (BVF)
Time frame: Change between baseline and 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Felix W. Wehrli, Ph.D. principal investigator
University of Pennsylvania, Department of Radiology
Peter J. Snyder, M.D. study director
University Of Pennsylvania, Department of Endocrinology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Virtual Bone Biopsy, Teriparatide and Zoledronic Acid in people with Osteoporosis, Osteopenia, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Aug 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Change in Trabecular Surface-to-curve Ratio (time frame: Change between baseline and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2017.