Study To Assess FRacTure Healing With SclerosTin Antibody - Hip

Fracture Healing Clinical Trial

— STARTT-Hip  

Official title:

A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Determine the Efficacy, Safety, and Tolerability of AMG 785 in Adults With a Fresh Unilateral Hip Fracture, Status Post Surgical Fixation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01081678
• Other study ID #: 20080394
• Status: Completed
• Phase: Phase 2
• Start date: June 20, 2010
• Est. completion date: May 10, 2013

Study information

• Verified date: September 2022
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is an international, multi-center study to determine the efficacy, safety, and tolerability of romosozumab (AMG 785) in adults with a fresh unilateral hip fracture, status post surgical fixation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 332
• Est. completion date: May 10, 2013
• Est. primary completion date: June 30, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 95 Years

Eligibility

Inclusion Criteria:

• Males and females, age 55 to 95 years

• fresh unilateral low energy intertrochanteric or femoral neck fracture as the primary injury, confirmed by X-ray and in the opinion of the treating surgeon amenable to repair by internal fixation

• internal fixation of the fracture with devices approved by local regulatory agency, performed no later than 7 days after injury for intertrochanteric or undisplaced femoral neck fractures and no later than 2 days after injury for displaced femoral neck fractures

• intertrochanteric fracture: sliding hip screw or IM nail

• femoral neck fracture: sliding hip screw or at least 3 cancellous screws

Exclusion Criteria:

• severe symptomatic osteoarthritis of the lower extremity

• inability to independently rise from armchair or walk 200 meters before hip fracture

• presence of concomitant injuries such as rib fractures, wrist fractures, or acute symptomatic vertebral fractures which severely impair the ability to rise from a chair

• associated extremity injuries including ipsilateral or contralateral fractures of the foot, tibia or fibula, wrist, humerus, femoral shaft, femoral head or hip dislocation, that may delay weight-bearing beyond one week after surgery

• head-injury, as defined by Glasgow Coma Scale < 13 prior to randomization

• use of bone grafts or bone substitutes at the time of fracture fixation

• major polytrauma or significant axial trauma, with Injury Severity Score > 16

• pathological fracture or history of metabolic or bone disease (except osteoporosis) that may interfere with the interpretation of the results, such as Paget's disease, rheumatoid arthritis, osteomalacia, osteopetrosis, ankylosing spondylitis, Cushing's disease, hyperprolactinemia

• history of symptomatic spinal stenosis that has not been surgically corrected. If surgically corrected, the subject must be asymptomatic to be eligible for the study.

• history of facial nerve paralysis

• malignancy (except fully resected cutaneous basal cell or squamous cell carcinoma, cervical carcinoma in situ) within the last 5 years

• history of solid organ or bone marrow transplants

• evidence of elevated transaminases (= 2.0 x upper limits of normal) or significantly impaired renal function (creatinine clearance of = 30 mL/min)

• evidence of current hypercalcemia or hypocalcemia (outside of 1.1 x the normal range)

• bone morphogenic proteins (BMP)-2 or BMP-7 at the time of definitive fracture fixation

Related Conditions & MeSH terms

• Fracture Healing
• Fractures, Bone

Intervention

Drug:
• Placebo
Administered by subcutaneous (under the skin) injection
• Romosozumab
Administered by subcutaneous injection

Locations

Country	Name	City	State
Argentina	Research Site	Buenos Aires
Argentina	Research Site	Buenos Aires
Australia	Research Site	Footscray	Victoria
Australia	Research Site	Liverpool	New South Wales
Belgium	Research Site	Brugge
Belgium	Research Site	Genk
Belgium	Research Site	Leuven
Belgium	Research Site	Liège
Belgium	Research Site	Liege
Bulgaria	Research Site	Blagoevgrad
Bulgaria	Research Site	Pleven
Bulgaria	Research Site	Plovdiv
Canada	Research Site	Cambridge	Ontario
Canada	Research Site	Guelph	Ontario
Canada	Research Site	Montreal	Quebec
Canada	Research Site	Ottawa	Ontario
Canada	Research Site	Quebec
Canada	Research Site	Quebec
Canada	Research Site	Red Deer	Alberta
Canada	Research Site	Toronto	Ontario
Canada	Research Site	Waterloo	Ontario
Denmark	Research Site	Ã…rhus C
Denmark	Research Site	Hvidovre
Denmark	Research Site	København NV
Denmark	Research Site	Viborg
Estonia	Research Site	Tallinn
Estonia	Research Site	Tartu
Finland	Research Site	Kuopio
Finland	Research Site	Oulu
Finland	Research Site	Turku
Germany	Research Site	Aachen
Germany	Research Site	Berlin
Germany	Research Site	Muenchen
Germany	Research Site	Muenster
Greece	Research Site	Athens
Greece	Research Site	Athens
Greece	Research Site	Larissa
Greece	Research Site	Patra
Greece	Research Site	Thessaloniki
Hong Kong	Research Site	Hong Kong
Hong Kong	Research Site	New Territories
Hungary	Research Site	Budapest
Hungary	Research Site	Miskolc
Hungary	Research Site	Nyiregyhaza
Hungary	Research Site	Szeged
India	Research Site	Bangalore	Karnataka
India	Research Site	Hyderabad	Andhra Pradesh
India	Research Site	Jaipur	Rajasthan
India	Research Site	Mangalore
India	Research Site	Mangalore	Karnataka
India	Research Site	Nashik	Maharashtra
India	Research Site	Nashik
India	Research Site	Pune	Maharashtra
India	Research Site	Pune	Maharashtra
Italy	Research Site	Firenze
Italy	Research Site	Milano
Italy	Research Site	Roma (RM)
Italy	Research Site	Verona
Latvia	Research Site	Riga
Latvia	Research Site	Valmiera
Lithuania	Research Site	Kaunas
Lithuania	Research Site	Vilnius
Netherlands	Research Site	Amsterdam
Netherlands	Research Site	Amsterdam
Netherlands	Research Site	Amsterdam
Netherlands	Research Site	Haarlem
Netherlands	Research Site	Nieuwegein
New Zealand	Research Site	Christchurch
Poland	Research Site	Kraków
Poland	Research Site	Lublin
Poland	Research Site	Warszawa
Poland	Research Site	Warszawa
Slovenia	Research Site	Celje
Slovenia	Research Site	Izola
Slovenia	Research Site	Jesenice
Slovenia	Research Site	Sempeter pri Gorici
Sweden	Research Site	Linköping
Sweden	Research Site	Lund
Switzerland	Research Site	Basel
Switzerland	Research Site	Lausanne
Switzerland	Research Site	Luzern
Switzerland	Research Site	Zurich
United Kingdom	Research Site	Barnet
United Kingdom	Research Site	Leeds
United Kingdom	Research Site	London
United Kingdom	Research Site	Newcastle
United Kingdom	Research Site	Norwich
United States	Research Site	Altoona	Pennsylvania
United States	Research Site	Aurora	Colorado
United States	Research Site	Birmingham	Alabama
United States	Research Site	Brooklyn	New York
United States	Research Site	Denver	Colorado
United States	Research Site	Indianapolis	Indiana
United States	Research Site	Philadelphia	Pennsylvania
United States	Research Site	Pomona	California
United States	Research Site	Rochester	New York
United States	Research Site	Saint Louis	Missouri
United States	Research Site	State College	Pennsylvania
United States	Research Site	Woodbury	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Belgium,  Bulgaria,  Canada,  Denmark,  Estonia,  Finland,  Germany,  Greece,  Hong Kong,  Hungary,  India,  Italy,  Latvia,  Lithuania,  Netherlands,  New Zealand,  Poland,  Slovenia,  Sweden,  Switzerland,  United Kingdom, 

References & Publications (1)

Schemitsch EH, Miclau T, Karachalios T, Nowak LL, Sancheti P, Poolman RW, Caminis J, Daizadeh N, Dent-Acosta RE, Egbuna O, Chines A, Maddox J, Grauer A, Bhandari M. A Randomized, Placebo-Controlled Study of Romosozumab for the Treatment of Hip Fractures. J Bone Joint Surg Am. 2020 Apr 15;102(8):693-702. doi: 10.2106/JBJS.19.00790. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Timed-Up-and-Go (TUG) Over Week 6 Through Week 20	Functional healing was measured by the timed-up-and-go test (TUG) over Weeks 6 through 20. During this assessment, the clinician timed the participant while they stood up from a seated position in a chair, walked three meters, turned around, walked three meters back to the chair, and returned to the seated position. A TUG value of ten seconds or less was considered normal for a healthy elderly person. Higher TUG values after hip fracture have been shown to be a predictor of future falls.; Least squares mean (LSM) estimates were based on a repeated measures model fitted with the log-transformed TUG values at weeks 2, 6, 12, 16, 20, 24, 36, 52 as the dependent variable and adjusted for treatment, randomized strata, gender, country category, pre-fracture community-dwelling status, pre-fracture walking aid use, quality of surgical fixation, visit, and treatment-by-visit interaction and back-transformed using the exponential transformation.	Weeks 6, 12, 16, and 20
Secondary	Timed-Up-and-Go (TUG) at Each Visit	During the timed-up-and-go test the clinician timed the participant while they stood up from a seated position in a chair, walked 3 meters, turned around, walked 3 meters back to the chair, and returned to a seated position. A TUG value of = 10 seconds is considered normal for a healthy elderly person.; LSMs were based on a repeated measures model adjusting for treatment, randomized strata, gender, country category, pre-fracture community-dwelling status, pre-fracture walking aid use, quality of surgical fixation, visit, and treatment-by-visit interaction.; Missing TUG values for participants still on study were imputed using the last observation carried forward (LOCF) when possible. If no observation could be carried forward, the maximum TUG value observed among all participants at a given visit was used. TUG values obtained after unplanned revision surgery were replaced by carrying forward the last available observed or imputed value prior to unplanned revision surgery.	Weeks 2, 6, 12, 16, 20, 24, 36, and 52
Secondary	Time to Radiographic Healing	Time to radiographic healing is the time interval from the surgery date for the eligible hip fracture to the date of radiographic healing, defined as effacement of the fracture lines by newly formed bone along the cortices and within the trabecular bone on anteroposterior and lateral (or oblique) radiographs. Radiographic fracture healing was determined by a panel of independent reviewers blinded to treatment.; The cumulative incidence function (CIF) method was used to estimate the median time to radiographic healing and the confidence intervals. Unplanned revision surgery to promote healing was considered a competing risk in CIF estimate.	52 weeks
Secondary	Radiographic Union Scale for Hip (RUSH) Score At Each Visit	The radiographic Union Scale for Hip (RUSH) is a semiquantitative scoring assessment to assess hip fracture healing after surgical repair. The RUSH has 4 key domains based on radiographic parameters used by orthopedic surgeons and radiologists in routine clinical practice including cortical bridging (4 to 12 points), cortical fracture line disappearance (4 to 12 points), trabecular consolidation (1 to 3 points), and trabecular index disappearance of fracture line (1 to 3 points). The score has a minimum of 10 points (definitely not healed) and a maximum of 30 points (definitely healed).	Weeks 2, 6, 12, 16, 20, 24, 36, and 52
Secondary	Harris Hip Score At Each Visit	The Harris Hip Score is a clinician-based outcome that assesses pain, function, deformity, and range of motion. The pain domain measures pain severity and its effect on activities and need for pain medication. The function domain consists of daily activities and gait. Deformity takes into account hip flexion, adduction, internal rotation, and extremity length discrepancy. Range of motion measures hip flexion, abduction, external and internal rotation, and adduction. The score ranges form 0-100 (best possible outcome) covering pain (0-44 points), function (0-47 points), absence of deformity (4 points), and range of motion (5 points). LSMs were based on a repeated measures model fitted with the Harris hip score values at weeks 2, 6, 12, 16, 20, 24, 36, and 52 as the dependent variable and adjusted for treatment, randomized strata, gender, pre-fracture community-dwelling status, pre-fracture walking aid use, quality of surgical fixation, visit, and treatment-by-visit interaction.	Weeks 2, 6, 12, 16, 20, 24, 36, and 52
Secondary	Hip Pain Score at Each Visit	Hip pain was assessed using a visual analog scale (VAS). Participants were asked to rate their pain as a result of the hip fracture on a 100 mm vertical scale with 0 indicating no pain at all and 100 indicating the worst pain they could imagine.; LSMs were based on a repeated measures model fitted with hip pain score values at weeks 2, 6, 12, 16, 20, 24, 36, and 52 as the dependent variable and adjusted for treatment, randomized strata, gender, pre-fracture community-dwelling status, pre-fracture walking aid use, quality of surgical fixation, visit, and treatment-by-visit interaction.	Weeks 2, 6, 12, 16, 20, 24, 36, and 52

External Links

•   AmgenTrials clinical trials website