Primary outcomeMean· 6, 12 months of treatment
Radiologic Evidence of Bone Healing
| Group | Value (units on a scale) | Spread |
|---|---|---|
| Immediate Teriparatide | 12.6 | 0.6 |
| Delayed Teriparatide | 11.2 | 1.3 |
Trial · Interventional
CompletedPhase 4Results postedRegistry dataFracture (FX) Improvement With Teriparatide: FiX-IT Study
Short name FiX-IT
NCTNCT01705587 (opens ClinicalTrials.gov in a new tab)Other idPRO12040560 (FiX-IT)
Overview
- Status
- Completed
- Phase
- Phase 4
- Enrollment
- 13 participants (actual)
- Sponsor
- Susan L. Greenspan · Other
- Design
- Randomized · Open label (no masking)
- Countries
1 country
United States
- Start
- Dec 2012
- Primary completion
- Sept 2016
- Completion
- Sept 2016
- First posted
- 12 Oct 2012 (estimated)
- Last update posted
- 12 Dec 2017
- Conditions
- Osteoporosis · Atypical Femoral Fracture
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
201220132014201520162017
- Ph 4
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
This open label comparison study examines the hypothesis that teriparatide given immediately following repair of an atypical subtrochanteric or diaphyseal femoral shaft fracture will enhance healing and improve bone mineral density compared to delayed treatment (after six months) with teriparatide or no treatment with teriparatide (patients who refuse therapy or for whom teriparatide is contraindicated). Patients with up-front teriparatide in addition will have greater quality of life measures and less pain compared to those with delayed or no therapy.
Interventions
- teriparatideDrug
Arms2
Experimental
Immediate teriparatide
Open label teriparatide given immediately following surgical repair of fracture
Experimental
Delayed teriparatide
Open label teriparatide given six months following surgical repair of fracture
Primary outcomes2
Outcomes the sponsor listed as primary.
Radiologic Evidence of Bone Healing
Time frame · 6, 12 months of treatment
Registry description
The radiologic indices of fracture healing included (1) cortical continuity on two of four cortices, (2) persistence of alignment, (3) decreased conspicuity of fracture line, and (4) increased callus formation. For each of these indices, healing was graded on a scale of 1 to 4 with 1 = no change (less than 25%), 2 = minimum healing (25-50%), 3 = moderate healing (50-75%), and 4 = complete healing (greater than 75%). A composite score was calculated by summing the subscale scores for the 4 indices. Composite score scale ranged from 4 to 16 with higher scores indicating more complete healing. The primary grading was performed by a radiologist with expertise in musculoskeletal radiology, then independently repeated by a second radiologist, both of whom were blinded to the study allocation.
Radiologic Evidence of Healing
Time frame · at 10 weeks for immediate teriparatide group
Registry description
Number of participants with persistence of alignment as determined by a radiologist.
Secondary outcomes(4)
Radiologic Healing
Time frame · at 2, 6, 24, and 48 weeks
Increased Bone Density
Time frame · at 6 and 12 months
Registry description
Percent change in Bone Mineral Density (BMD) as assessed by dual x-ray absorptiometry (DXA) at the spine, contralateral hip, distal 1/3 radius, and femoral neck
Quality of Life Improvements
Time frame · at 12 months
Registry description
Assessed by quality of life questionnaire (SF-36). There are 8 subscales each ranging from 0-100 with higher scores indicating better quality of life.
Difference in Biochemical Markers of Bone Turnover
Time frame · intervals over 12-18 months depending on treatment group
Registry description
upfront therapy group compared to delayed therapy group and no therapy group
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Primary outcomeCount of participants· at 10 weeks for immediate teriparatide group
Radiologic Evidence of Healing
| Group | Value (Participants) |
|---|---|
| Immediate Teriparatide | 5 |
| Delayed Teriparatide | 4 |
Secondary and other outcome results(4)
Secondary outcome· at 2, 6, 24, and 48 weeks
Radiologic Healing
| Group | Value |
|---|---|
| Immediate Teriparatide | not posted |
| Delayed Teriparatide | not posted |
Secondary outcomeMean· at 6 and 12 months
Increased Bone Density
| Group | Value (percentage change in BMD) | Spread |
|---|---|---|
| Immediate Teriparatide | 2.1 | 1.5 |
| Delayed Teriparatide | -0.6 | 1.3 |
Secondary outcomeMean· at 12 months
Quality of Life Improvements
| Group | Value (units on a scale) | Spread |
|---|---|---|
| Immediate Teriparatide | 49.3 | 6.5 |
| Delayed Teriparatide | 65.0 | 20.3 |
Secondary outcome· intervals over 12-18 months depending on treatment group
Difference in Biochemical Markers of Bone Turnover
| Group | Value |
|---|---|
| Immediate Teriparatide | not posted |
| Delayed Teriparatide | not posted |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Immediate TeriparatideOpen label teriparatide given immediately following surgical repair of fracture teriparatide: 20 microgram once-daily subcutaneous injection | 0 / 7 | 3 / 7 | 5 / 7 |
| Delayed TeriparatideOpen label teriparatide given six months following surgical repair of fracture teriparatide: 20 microgram once-daily subcutaneous injection | 0 / 6 | 2 / 6 | 5 / 6 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- Female
- Age
- Not stated
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria:
* postmenopausal women
* with osteoporosis who have been on bisphosphonate therapy for one year or more (all bisphosphonates will be included such as alendronate, risdedronate, ibandronate, or zoledronic acid).
* Patients will also be included if they are on glucocorticoids or other medications known to affect bone mineral metabolism as these are often found in patients with these types of fractures.
* sustain an atypical subtrochanteric or diaphyseal femoral shaft fracture as defined by the the 2010 ASBMR task force. An atypical fracture must include all of the following: (1) a location in the femur distal to lesser trochanter; (2) no trauma or minimal trauma as a fall; (3) transverse or short oblique configuration; (4) noncomminuted; and (5) complete fracture extends through both cortices and may be associated with a medial spike; incomplete fractures involve only the lateral cortex. Patients who have an incomplete fracture can be included if they fall into the 2010 ASBMR task force definition.
Exclusion Criteria:
* men
* children
* those who have had radiation therapy
* Paget's disease
* treatment with teriparatide for two year in the past
* metastatic bone disease
* active cancer
* hypercalcemia
* hyperparathyroidism
* metabolic disease other than osteoporosis
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