Fracture (FX) Improvement With Teriparatide: FiX-IT Study (FiX-IT)
6 november 2017 bijgewerkt door: 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.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Ingrijpend
Inschrijving (Werkelijk)
13
Fase
- Fase 4
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Pennsylvania
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Pittsburgh, Pennsylvania, Verenigde Staten, 15213
- University of Pittsburgh, Osteoporosis Prevention & Treatment Center
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Vrouw
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: Immediate teriparatide
Open label teriparatide given immediately following surgical repair of fracture
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20 microgram once-daily subcutaneous injection
Andere namen:
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Experimenteel: Delayed teriparatide
Open label teriparatide given six months following surgical repair of fracture
|
20 microgram once-daily subcutaneous injection
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Radiologic Evidence of Bone Healing
Tijdsspanne: 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
Tijdsspanne: at 10 weeks for immediate teriparatide group
|
Number of participants with persistence of alignment as determined by a radiologist.
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at 10 weeks for immediate teriparatide group
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Radiologic Healing
Tijdsspanne: at 2, 6, 24, and 48 weeks
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at 2, 6, 24, and 48 weeks
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|
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Increased Bone Density
Tijdsspanne: 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
Tijdsspanne: 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
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Difference in Biochemical Markers of Bone Turnover
Tijdsspanne: intervals over 12-18 months depending on treatment group
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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
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Hoofdonderzoeker: Susan L. Greenspan, MD, University of Pittsburgh
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 december 2012
Primaire voltooiing (Werkelijk)
1 september 2016
Studie voltooiing (Werkelijk)
1 september 2016
Studieregistratiedata
Eerst ingediend
9 oktober 2012
Eerst ingediend dat voldeed aan de QC-criteria
11 oktober 2012
Eerst geplaatst (Schatting)
12 oktober 2012
Updates van studierecords
Laatste update geplaatst (Werkelijk)
12 december 2017
Laatste update ingediend die voldeed aan QC-criteria
6 november 2017
Laatst geverifieerd
1 november 2017
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- PRO12040560 (FiX-IT)
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