Osteoporosis, Age-RelatedPhase 3TERAFRAPNCT02091492
Teriparatide for Fracture Repair in Humans
A Phase 3 study testing Teriparatide in people with Osteoporosis, Age-Related and Humeral Fractures, run by Medical University of Vienna at 1 site in Austria.
Trial summary
This study will test the hypothesis that daily subcuaneous administration of 20µg of teriparatide (TPTD) as compared to daily subcuaneous placebo for twelve weeks accelerates proximal 2-segment humerus fracture healing and improves the three dimensional structural properties of bone as measured via quantitative bone… Read more about this study
- Who is it for?
- Ages 60 to 90 years
- Conditions the study is for
- Osteoporosis, Age-Related, Humeral Fractures
- What is being tested?
- Teriparatide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteAustria
- Study dates
- Jun 2014to Sep 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- recent proximal 2-segment humerus fracture (0-8 days post fracture)
- no surgical treatment at fractured site
- signed informed consent
- postmenopausal female and male patients aged 60 - 85 years
- established osteoporosis as defined by BMD measured with DXA-technology (dual energy X-ray absorptiometry) with a T-score ≤ -2.0 spine or hip
Who cannot join
- Hypersensitivity to the active substance or to any of the excipients.
- Pre-existing hypercalcemia
- Severe renal impairment (eGFR< 35ml/min)
- Metabolic bone diseases (including hyperparathyroidism and Paget's disease of the bone) other than primary osteoporosis or glucorticoid-induced osteoporosis.
- Unexplained elevations of alkaline phosphatase
- Prior external beam or implant radiation therapy to the skeleton
Show all 14Show fewer
- Patients with skeletal malignancies or bone metastases should be excluded from treatment with teriparatide.
- any prior antiresorptive therapy (oral/intravenous bisphosphonates, RANKL-antibody, SERMs)
- any prior strontium ranelate therapy
- any prior TPTD of PTH 1-84 therapy
- malignancies ≤ 5 years except basalioma
- hypo-/hypercalcemia
- baseline 25-OH vitamin D3 level ≤10 ng/ml
- prosthesis at fractured and contralateral humerus
Trial locations and contacts
1 site in 1 country.
Austria1 site
Medical University Vienna; St. Vincent Hospital
Vienna, State of Vienna, 1060
About this study
Official title: Teriparatide for Fracture Repair in Humans: A Prospective, Randomized, Double-blind Placebo-controlled Pilot Study in Female and Male Patients With Proximal Humerus Fracture: The TERAFRAP Study
This study will test the hypothesis that daily subcuaneous administration of 20µg of teriparatide (TPTD) as compared to daily subcuaneous placebo for twelve weeks accelerates proximal 2-segment humerus fracture healing and improves the three dimensional structural properties of bone as measured via quantitative bone image analysis and finite element modeling assessed by quantitative computed tomography.
Read the detailed description
- Primary objective: The primary objective is the quantitative assessment of fracture healing (2-segment proximal humerus frafcture) in the treatment (daily teriapratide 20µg subcitaneous injection for 12 weeks) and in the placebo group (daily placebo subcutaneous injection for 12 weeks) based on computed tomography data (QCT; baseline and after 12 weeks) and computational analysis of the three simensional bone structure in the fracture zone. Bone structure will be assessed by means of quantized bone texture characteristics (callus formation, improvement of trabecualar and cortical bone structure) in the vicinity of the fracture.
- Secondary objectives:
2.1.Detection and quantification of changes in bone mineralization at the fracture site between a baseline QCT scan and a follow-up QCT scan (planned interval: 12 weeks) using 3-D texture-based cluster analysis between the two groups.
2.2 Evaluation of bone strength variation in the proximal humerus and the measurement of biomechanical properties (stiffness, strength, damage) based on the Finite Element (FE) technique between the two groups.
2.3.Baseline characterization of osteoporotic study population: age, sex, concomitant diseases, serum markers of bone formation and bone resorption, serum colecalciferol levels.
2.4.Evaluation of fasting bone formation and resorption markers at baseline and after 3 months follow up between the TPDT and the placebo group.
2.5.Assessment of quality of life improvement for TPTD and placebo groups with EQ-5D questionnaire (measurement every 4 weeks).
2.6.Assessment of pain reduction in TPTD and placebo groups by visual analog scale (VAS) during 12 weeks (measurement every 4 weeks).
2.7.Assessment of functional testing after 3 and 6 months (functional testing score (ASES Score: "American Shoulder and Elbow Surgeon Score")
2.8.Dual energy x-ray absorptiometry (DXA) bone mineral density (BMD) measurements of lumbar spine and early changes of geometrical hip parameters (cross sectional area - CSA, cross sectional moment of inertia - CSMI), hip BMD(femoral neck and total hip area) and total body (lean mass, fat mass, total body BMD)
2.9. Number of Participants with Adverse Events as a Measure of Safety and Tolerability
- Conditions
- Osteoporosis, Age-Related, Humeral Fractures
- Being tested
- Teriparatide, Placebo
- Keywords
- Proximal humerus fracture, teriparatide
- Medical subject headings
- Osteoporosis, Humeral Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TeriparatideDrug
Also called Forteo
Teriparatide 20 µg sc (subcutaneous injection) each day for 12 weeks
PlaceboDrug
Placebo teriparatide sc (subcutaneous injection) each day for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Teriparatide | Active comparator | Teriparatide 20µg daily subcutaneous injection for 12 weeks after proximal humerus fracture Receives: Drug: Teriparatide |
| Placebo-Teriparatide | Placebo comparator | Placebo-Teriparatide 20 µg daily subcutaneous injection for 12 weeks after proximal humerus fracture Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of bone and callus patterns in the CT data at the fracture site
As a basis for change quantification, we will identify 3D micro-architecture patterns that occur in the study CT data. These patterns are either learned based on annotated examples, manual segmentation of specific regions in a number of reference examples, or in a data-driven fashion (computer based identification of pattern classes).
Measured: 12 weeks
Secondary outcomes (1)
Finite Element Analysis (FEA) of QCT (quantitative computed tomography) data
The FEA Method will be a second diagnostic tool in order to evaluate the change in bone strength in the proximal humerus during treatment.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2014 (estimated)
- Study startJun 2014
- Primary completionSep 2015 (estimated)
- Study completionSep 2015 (estimated)
Why it stopped: no participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteoporosis, Age-RelatedStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Christian Muschitz, Medical University of Vienna
- Investigators
- Christian Muschitz, M.D., Principal investigator, Medical University Vienna, St. Vincent Hospital Vienna, Austria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02091492
- Sponsor's protocol ID
- Vinforce_006
- Other IDs
- # 317.276.2000
- Acronym
- TERAFRAP
- Status last verified
- Sep 2015
- First submitted
- 13 Mar 2014
- Last updated
- 17 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Aspenberg P, Johansson T. Teriparatide improves early callus formation in distal radial fractures. Acta Orthop. 2010 Apr;81(2):234-6. doi: 10.3109/17453671003761946.
PubMed 20367417
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Teriparatide for Fracture Repair in Humans: A Prospective, Randomized, Double-blind Placebo-controlled Pilot Study in Female and Male Patients With Proximal Humerus Fracture: The TERAFRAP Study
- ClinicalTrials.gov ID
- NCT02091492
- Acronym / sponsor ID
- TERAFRAP / Vinforce_006
- Conditions
- Osteoporosis, Age-Related, Humeral Fractures
- Keywords
- Proximal humerus fracture, teriparatide
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: no participants
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Sep 2015 (estimated)
- Study completion
- Sep 2015 (estimated)
- First posted
- 19 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will test the hypothesis that daily subcuaneous administration of 20µg of teriparatide (TPTD) as compared to daily subcuaneous placebo for twelve weeks accelerates proximal 2-segment humerus fracture healing and improves the three dimensional structural properties of bone as measured via quantitative bone image analysis and finite element modeling assessed by quantitative computed tomography.
Detailed description
- Primary objective: The primary objective is the quantitative assessment of fracture healing (2-segment proximal humerus frafcture) in the treatment (daily teriapratide 20µg subcitaneous injection for 12 weeks) and in the placebo group (daily placebo subcutaneous injection for 12 weeks) based on computed tomography data (QCT; baseline and after 12 weeks) and computational analysis of the three simensional bone structure in the fracture zone. Bone structure will be assessed by means of quantized bone texture characteristics (callus formation, improvement of trabecualar and cortical bone structure) in the vicinity of the fracture.
- Secondary objectives:
2.1.Detection and quantification of changes in bone mineralization at the fracture site between a baseline QCT scan and a follow-up QCT scan (planned interval: 12 weeks) using 3-D texture-based cluster analysis between the two groups.
2.2 Evaluation of bone strength variation in the proximal humerus and the measurement of biomechanical properties (stiffness, strength, damage) based on the Finite Element (FE) technique between the two groups.
2.3.Baseline characterization of osteoporotic study population: age, sex, concomitant diseases, serum markers of bone formation and bone resorption, serum colecalciferol levels.
2.4.Evaluation of fasting bone formation and resorption markers at baseline and after 3 months follow up between the TPDT and the placebo group.
2.5.Assessment of quality of life improvement for TPTD and placebo groups with EQ-5D questionnaire (measurement every 4 weeks).
2.6.Assessment of pain reduction in TPTD and placebo groups by visual analog scale (VAS) during 12 weeks (measurement every 4 weeks).
2.7.Assessment of functional testing after 3 and 6 months (functional testing score (ASES Score: "American Shoulder and Elbow Surgeon Score")
2.8.Dual energy x-ray absorptiometry (DXA) bone mineral density (BMD) measurements of lumbar spine and early changes of geometrical hip parameters (cross sectional area - CSA, cross sectional moment of inertia - CSMI), hip BMD(femoral neck and total hip area) and total body (lean mass, fat mass, total body BMD)
2.9. Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Teriparatide | Active comparator | Drug: TeriparatideTeriparatide 20µg daily subcutaneous injection for 12 weeks after proximal humerus fracture |
| Placebo-Teriparatide | Placebo comparator | Drug: PlaceboPlacebo-Teriparatide 20 µg daily subcutaneous injection for 12 weeks after proximal humerus fracture |
Who may qualify
- Ages
- 60 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- recent proximal 2-segment humerus fracture (0-8 days post fracture)
- no surgical treatment at fractured site
- signed informed consent
- postmenopausal female and male patients aged 60 - 85 years
- established osteoporosis as defined by BMD measured with DXA-technology (dual energy X-ray absorptiometry) with a T-score ≤ -2.0 spine or hip
Key exclusion criteria (14 listed)
- Hypersensitivity to the active substance or to any of the excipients.
- Pre-existing hypercalcemia
- Severe renal impairment (eGFR< 35ml/min)
- Metabolic bone diseases (including hyperparathyroidism and Paget's disease of the bone) other than primary osteoporosis or glucorticoid-induced osteoporosis.
- Unexplained elevations of alkaline phosphatase
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 |
|---|---|---|
| TeriparatideAlso: ForteoTeriparatide 20 µg sc (subcutaneous injection) each day for 12 weeks | Drug | Teriparatide |
| PlaceboPlacebo teriparatide sc (subcutaneous injection) each day for 12 weeks | Drug | Placebo-Teriparatide |
Primary outcome
Identification of bone and callus patterns in the CT data at the fracture site
Time frame: 12 weeks
As a basis for change quantification, we will identify 3D micro-architecture patterns that occur in the study CT data. These patterns are either learned based on annotated examples, manual segmentation of specific regions in a number of reference examples, or in a data-driven fashion (computer based identification of pattern classes).
1 secondary outcome
Finite Element Analysis (FEA) of QCT (quantitative computed tomography) data
Time frame: 12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2015.
- Background: PubMed 20367417Aspenberg P, Johansson T. Teriparatide improves early callus formation in distal radial fractures. Acta Orthop. 2010 Apr;81(2):234-6. doi: 10.3109/17453671003761946.
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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.
Christian Muschitz, M.D. principal investigator
Medical University Vienna, St. Vincent Hospital Vienna, Austria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Teriparatide in people with Osteoporosis, Age-Related and Humeral Fractures, run by Medical University of Vienna at 1 site in Austria.
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 5 inclusion and 14 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: withdrawn, as of the sponsor's last update on 17 Sep 2015. 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 Austria. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Identification of bone and callus patterns in the CT data at the fracture site (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02091492, which also lists 1 linked publication.
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 17 Sep 2015.