Study To Assess FRacTure Healing With SclerosTin Antibody - Hip
STARTT-Hip
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
1 other identifier
interventional
332
24 countries
99
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2010
Typical duration for phase_2
99 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 4, 2010
CompletedFirst Posted
Study publicly available on registry
March 5, 2010
CompletedStudy Start
First participant enrolled
June 20, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
May 10, 2013
CompletedResults Posted
Study results publicly available
May 2, 2019
CompletedSeptember 21, 2022
September 1, 2022
2 years
March 4, 2010
April 10, 2019
September 8, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
Timed-Up-and-Go (TUG) at Each Visit
Weeks 2, 6, 12, 16, 20, 24, 36, and 52
Time to Radiographic Healing
52 weeks
Radiographic Union Scale for Hip (RUSH) Score At Each Visit
Weeks 2, 6, 12, 16, 20, 24, 36, and 52
Harris Hip Score At Each Visit
Weeks 2, 6, 12, 16, 20, 24, 36, and 52
Hip Pain Score at Each Visit
Weeks 2, 6, 12, 16, 20, 24, 36, and 52
Study Arms (4)
Placebo
PLACEBO COMPARATORParticipants received placebo to romosozumab administered by subcutaneous injection on day 1 and at weeks 2, 6, and 12.
Romosozumab 70 mg
EXPERIMENTALParticipants received 70 mg romosozumab administered by subcutaneous injection on day 1 and at weeks 2, 6, and 12.
Romosozumab 140 mg
EXPERIMENTALParticipants received 140 mg romosozumab administered by subcutaneous injection on day 1 and at weeks 2, 6, and 12.
Romosozumab 210 mg
EXPERIMENTALParticipants received 210 mg romosozumab administered by subcutaneous injection on day 1 and at weeks 2, 6, and 12.
Interventions
Administered by subcutaneous injection
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
Study Sites (99)
Research Site
Birmingham, Alabama, 35294, United States
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Pomona, California, 91767, United States
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Aurora, Colorado, 80012, United States
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Denver, Colorado, 80204, United States
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Indianapolis, Indiana, 46202, United States
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Woodbury, Minnesota, 55125, United States
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St Louis, Missouri, 63110, United States
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Brooklyn, New York, 11220, United States
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Rochester, New York, 14642, United States
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Altoona, Pennsylvania, 16602, United States
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Philadelphia, Pennsylvania, 19104, United States
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State College, Pennsylvania, 16801, United States
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Buenos Aires, C1012AAR, Argentina
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Buenos Aires, C1419AHN, Argentina
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Liverpool, New South Wales, 2170, Australia
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Footscray, Victoria, 3011, Australia
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Bruges, 8000, Belgium
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Genk, 3600, Belgium
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Leuven, 3000, Belgium
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Liège, 4020, Belgium
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Liège, 4000, Belgium
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Blagoevgrad, 2700, Bulgaria
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Pleven, 5800, Bulgaria
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Plovdiv, 4002, Bulgaria
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Red Deer, Alberta, T4N 6V7, Canada
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Cambridge, Ontario, N1R 3G2, Canada
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Guelph, Ontario, N1E 4J4, Canada
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Ottawa, Ontario, K1Y 4E9, Canada
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Toronto, Ontario, M5C 1R6, Canada
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Waterloo, Ontario, N2J 1C4, Canada
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Montreal, Quebec, H4J 1C5, Canada
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Québec, Quebec, G1J 1Z4, Canada
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Québec, Quebec, G1R 2J6, Canada
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Ã…rhus C, 8000, Denmark
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Hvidovre, 2650, Denmark
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København NV, 2400, Denmark
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Viborg, 8800, Denmark
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Tallinn, 11312, Estonia
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Tartu, 50410, Estonia
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Kuopio, 70211, Finland
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Oulu, 90220, Finland
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Turku, 20520, Finland
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Aachen, 52074, Germany
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Berlin, 12200, Germany
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München, 80336, Germany
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Münster, 48149, Germany
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Athens, 12462, Greece
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Athens, 14561, Greece
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Larissa, 41110, Greece
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Pátrai, 26500, Greece
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Thessaloniki, 56429, Greece
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Hong Kong, Hong Kong
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New Territories, Hong Kong
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Budapest, 1081, Hungary
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Miskolc, 3526, Hungary
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Nyíregyháza, 4400, Hungary
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Szeged, 6725, Hungary
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Hyderabad, Andhra Pradesh, 500 063, India
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Bangalore, Karnataka, 560 054, India
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Mangalore, Karnataka, 575 002, India
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Nashik, Maharashtra, 422 002, India
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Pune, Maharashtra, 411 005, India
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Pune, Maharashtra, 411 044, India
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Jaipur, Rajasthan, 302 022, India
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Mangalore, 575 001, India
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Nashik, 422 009, India
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Florence, 50139, Italy
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Milan, 20142, Italy
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Roma (RM), 00133, Italy
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Verona, 37126, Italy
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Riga, 1005, Latvia
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Valmiera, 4201, Latvia
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Kaunas, 44320, Lithuania
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Vilnius, 04130, Lithuania
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Amsterdam, 1061 AE, Netherlands
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Amsterdam, 1091 AC, Netherlands
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Amsterdam, 1105 AZ, Netherlands
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Haarlem, 2035 RC, Netherlands
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Nieuwegein, 3435 CM, Netherlands
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Christchurch, 8022, New Zealand
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Kraków, 31-826, Poland
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Lublin, 20-718, Poland
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Warsaw, 00-739, Poland
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Warsaw, 03-242, Poland
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Celje, 3000, Slovenia
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Izola, 6310, Slovenia
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Jesenice, 4270, Slovenia
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Šempeter pri Gorici, 5290, Slovenia
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Linköping, 581 85, Sweden
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Lund, 221 85, Sweden
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Basel, 4031, Switzerland
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Lausanne, 1011, Switzerland
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Lucerne, 6000, Switzerland
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Zurich, 8063, Switzerland
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Barnet, EN5 3DJ, United Kingdom
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Leeds, LS1 3EX, United Kingdom
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London, E1 1BB, United Kingdom
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Newcastle, NE1 4LP, United Kingdom
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Norwich, NR4 7UY, United Kingdom
Related 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.
PMID: 31977817BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Amgen Inc.
Study Officials
- STUDY DIRECTOR
MD
Amgen
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 4, 2010
First Posted
March 5, 2010
Study Start
June 20, 2010
Primary Completion
June 30, 2012
Study Completion
May 10, 2013
Last Updated
September 21, 2022
Results First Posted
May 2, 2019
Record last verified: 2022-09