Fracture (FX) Improvement With Teriparatide: FiX-IT Study (FiX-IT)
6 november 2017 uppdaterad av: Susan L. Greenspan
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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Up to 24 postmenopausal women with osteoporosis who have been on bisphosphonate therapy for one year or more at any point prior to fracture and have sustained an atypical subtrochanteric or diaphyseal fracture will be enrolled.
Subjects randomized to the two intervention arms will self-administer a daily SQ injection of the study medication for 12 months.
The primary objective is to demonstrate greater radiologic evidence of healing at 10 weeks in patients on immediate teriparatide compared to those on delayed teriparatide who receive therapy six months after fracture.
Secondary end points include (1) radiologic healing at 2, 6, 24, and 46 weeks; (2) increased bone density at 6 and 12 months as assessed by dual x-ray absorptiometry (DXA) at the spine, contralateral hip, and femoral neck; (3) quality of life improvements at 10 weeks and 6 months as assessed by quality of life questionnaire and pain score; and (4) differences in biochemical markers of bone turnover in patient with upfront therapy compared to patients with delayed therapy and patients who refuse therapy or for whom teriparatide is contraindicated.
Studietyp
Interventionell
Inskrivning (Faktisk)
13
Fas
- Fas 4
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Pennsylvania
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Pittsburgh, Pennsylvania, Förenta staterna, 15213
- University of Pittsburgh, Osteoporosis Prevention & Treatment Center
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-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Kvinna
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Immediate teriparatide
Open label teriparatide given immediately following surgical repair of fracture
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20 microgram once-daily subcutaneous injection
Andra namn:
|
|
Experimentell: Delayed teriparatide
Open label teriparatide given six months following surgical repair of fracture
|
20 microgram once-daily subcutaneous injection
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Radiologic Evidence of Bone Healing
Tidsram: 6, 12 months of treatment
|
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.
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6, 12 months of treatment
|
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Radiologic Evidence of Healing
Tidsram: at 10 weeks for immediate teriparatide group
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Number of participants with persistence of alignment as determined by a radiologist.
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at 10 weeks for immediate teriparatide group
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Radiologic Healing
Tidsram: at 2, 6, 24, and 48 weeks
|
at 2, 6, 24, and 48 weeks
|
|
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Increased Bone Density
Tidsram: at 6 and 12 months
|
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
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at 6 and 12 months
|
|
Quality of Life Improvements
Tidsram: at 12 months
|
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.
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at 12 months
|
|
Difference in Biochemical Markers of Bone Turnover
Tidsram: intervals over 12-18 months depending on treatment group
|
upfront therapy group compared to delayed therapy group and no therapy group
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intervals over 12-18 months depending on treatment group
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Susan L. Greenspan, MD, University of Pittsburgh
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 december 2012
Primärt slutförande (Faktisk)
1 september 2016
Avslutad studie (Faktisk)
1 september 2016
Studieregistreringsdatum
Först inskickad
9 oktober 2012
Först inskickad som uppfyllde QC-kriterierna
11 oktober 2012
Första postat (Uppskatta)
12 oktober 2012
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
12 december 2017
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
6 november 2017
Senast verifierad
1 november 2017
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- PRO12040560 (FiX-IT)
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .