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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01473589




Registration number
NCT01473589
Ethics application status
Date submitted
14/11/2011
Date registered
17/11/2011
Date last updated
16/04/2015

Titles & IDs
Public title
Effect of Teriparatide on Hip Fracture Healing
Scientific title
Effect of Teriparatide on Femoral Neck Fracture Healing
Secondary ID [1] 0 0
B3D-MC-GHDN
Secondary ID [2] 0 0
13467
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Femur Neck Fracture 0 0
Condition category
Condition code
Injuries and Accidents 0 0 0 0
Fractures
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Teriparatide
Treatment: Drugs - Placebo
Treatment: Other - Calcium supplementation
Treatment: Other - Vitamin D supplementation

Placebo comparator: Placebo - Administered once daily by subcutaneous (SC) injection for 6 months

Experimental: Teriparatide - 20 microgram (µg) administered once daily by SC injection for 6 months


Treatment: Drugs: Teriparatide
Administered by SC injection

Treatment: Drugs: Placebo
Administered by SC injection

Treatment: Other: Calcium supplementation
Administered orally

Treatment: Other: Vitamin D supplementation
Administered orally
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With No Revision Surgery at 12 Months After Internal Fixation of a Low-Trauma Femoral Neck Fracture
Timepoint [1] 0 0
12 months
Secondary outcome [1] 0 0
Percentage of Participants With Radiographic Evidence of Healing
Timepoint [1] 0 0
Randomization up to 12 months
Secondary outcome [2] 0 0
Percentage of Participants With Pain Control During Ambulation
Timepoint [2] 0 0
Up to 12 months
Secondary outcome [3] 0 0
Percentage of Participants Without Severe Fracture-Site Pain During 24 Hours Prior to Visit
Timepoint [3] 0 0
Up to 12 months
Secondary outcome [4] 0 0
Percentage of Participants Without Severe Fracture-Site Pain During Weight Bearing
Timepoint [4] 0 0
Up to 12 months
Secondary outcome [5] 0 0
Percentage of Participants With Functional Evidence of Healing
Timepoint [5] 0 0
12 Months
Secondary outcome [6] 0 0
Percentage of Participants Able to Ambulate
Timepoint [6] 0 0
Up to 12 months
Secondary outcome [7] 0 0
Percentage of Participants Who Regain Their Prefracture Ambulatory Status
Timepoint [7] 0 0
Up to 12 months
Secondary outcome [8] 0 0
Mean Change From Baseline to 6 Months in Worst Fracture-Site Pain
Timepoint [8] 0 0
Baseline, 6 Months
Secondary outcome [9] 0 0
Mean Change From Baseline to 6 Months in Gait Speed
Timepoint [9] 0 0
Baseline, up to 6 Months
Secondary outcome [10] 0 0
Time to Revision Surgery
Timepoint [10] 0 0
Baseline to revision surgery (up to 14.14 Months)
Secondary outcome [11] 0 0
Mean Change From Baseline to 6 Months on Short Form-12 (SF-12) Physical (PCS) and Mental Component Summary (MCS) Scores
Timepoint [11] 0 0
Baseline, up to 6 Months
Secondary outcome [12] 0 0
Mean Change From Baseline to 6 Months on Western Ontario McMaster Osteoarthritis Index (WOMAC)
Timepoint [12] 0 0
Baseline, up to 6 Months
Secondary outcome [13] 0 0
Mean Change From Baseline to 6 Months on European Quality of Life Questionnaire (EQ-5D) Health State Score
Timepoint [13] 0 0
Baseline, up to 6 Months

Eligibility
Key inclusion criteria
* Community dwelling men and postmenopausal women who were ambulatory before sustaining a low-trauma, unilateral femoral neck fracture (displaced or nondisplaced)
* Other than femoral neck fracture, be free of incapacitating conditions and have a life expectancy of at least 2 years
* Have received or are eligible for treatment with internal fixation (sliding hip screw or multiple cancellous screws) for the femoral neck fracture (the surgical procedure itself is not performed as part of this study)
* Have given written informed consent (participant or proxy) after being informed of the risks, medications, and study procedures
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Increased baseline risk of osteosarcoma
* History of unresolved skeletal diseases affecting bone metabolism other than primary osteoporosis
* Abnormally elevated serum calcium at screening
* Abnormally elevated serum intact parathyroid hormone (PTH) (1-84) at screening
* Severe vitamin D deficiency at screening
* Active liver disease or jaundice
* Significantly impaired renal function
* Abnormal thyroid function not corrected by therapy
* History of malignant neoplasm in the 5 years prior to screening
* History of bone marrow or solid organ transplantation
* History of symptomatic nephrolithiasis or urolithiasis in the 1 year prior to screening
* Previous treatment with the following bone active drugs is allowed but must be discontinued at screening: oral bisphosphonates, selective estrogen receptor modulators (SERMs), calcitonin, estrogen (oral, transdermal, or injectable), progestin, estrogen analog, estrogen agonist, estrogen antagonist or tibolone, and active vitamin D3 analogs. Androgen or other anabolic steroid use must be discontinued, except for use of physiologic replacement testosterone
* Previous treatment with the following bone active drugs is exclusionary, if the stated treatment durations have been met: strontium ranelate for any duration, intravenous bisphosphonates in the 12 months preceding screening, and/or denosumab in the 6 months preceding screening
* Prior treatment with PTH, teriparatide, or other PTH analogs, or prior participation in any other clinical trial studying PTH, teriparatide, or other PTH analogs
* Local or systemic treatment with bone morphogenic proteins or any other growth factor
* Previous fracture(s) or bone surgery in the currently fractured hip
* Soft-tissue infection at the operation site
* Treatment with bone grafting or osteotomies
* Treatment with augmentation using any type of degradable cement, hydroxyapatite-coated implants, or with noninvasive interventions
* Associated major injuries of a lower extremity including fractures of the foot, ankle, tibia, fibula, knee, femur, femoral head or pelvis; dislocations of the ankle, knee or hip

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2013
Sample size
Target
Accrual to date
Final
122
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Recruitment hospital [1] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Penrith
Recruitment hospital [2] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Heidelberg
Recruitment hospital [3] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - St Albans
Recruitment hospital [4] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Nedlands
Recruitment postcode(s) [1] 0 0
2751 - Penrith
Recruitment postcode(s) [2] 0 0
3081 - Heidelberg
Recruitment postcode(s) [3] 0 0
3021 - St Albans
Recruitment postcode(s) [4] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Idaho
Country [6] 0 0
United States of America
State/province [6] 0 0
Michigan
Country [7] 0 0
United States of America
State/province [7] 0 0
Missouri
Country [8] 0 0
United States of America
State/province [8] 0 0
Montana
Country [9] 0 0
United States of America
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Nebraska
Country [10] 0 0
United States of America
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North Carolina
Country [11] 0 0
United States of America
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North Dakota
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United States of America
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Pennsylvania
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United States of America
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Texas
Country [14] 0 0
United States of America
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Utah
Country [15] 0 0
Canada
State/province [15] 0 0
Ontario
Country [16] 0 0
Canada
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Quebec
Country [17] 0 0
Denmark
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Aarhus
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Denmark
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Hillerod
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Denmark
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Kobenhavn
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Denmark
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Koege
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Estonia
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Tartu
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Finland
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Oulu
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Finland
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Turku
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Hong Kong
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Hong Kong
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India
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Ahmedabad
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India
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Attavar, Mangalore
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India
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Bangalore
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India
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Hyderabaad
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India
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Nagpur
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India
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Vadodara
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Israel
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Haifa
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Israel
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Jerusalem
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Japan
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Aichi
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Japan
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Chiba
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Japan
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Fukuoka
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Japan
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Fukushima
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Gunma
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Hiroshima
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Ibaraki
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Japan
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Japan
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Kagawa
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Nagano
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Japan
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Niigata
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Japan
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Ohita
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Japan
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Osaka
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Japan
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Saga
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Japan
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Shimane
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Japan
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Shizuoka
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Japan
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Toyama
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Japan
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Toyko
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Japan
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Yamaguchi
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Japan
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Yamanashi
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Korea, Republic of
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Seongnam-Si
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Korea, Republic of
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Seoul
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Latvia
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Riga
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Lithuania
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Kaunas
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Lithuania
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Klaipeda
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Lithuania
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Vilnius
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New Zealand
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Christchurch
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New Zealand
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Takapuna
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New Zealand
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Wellington South
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Norway
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Toensberg
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Puerto Rico
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San Juan
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Spain
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Alcira
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Spain
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Barcelona
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Spain
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Girona
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Spain
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Guadalajara
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Spain
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Marbella
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Spain
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Pozuelo De Alarcon
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Sweden
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Malmo
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Sweden
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Mölndal
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Sweden
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Stockholm
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Taiwan
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Jhonghe City
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Taiwan
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Kaohsiung
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Taiwan
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Taichung City
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Taiwan
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Taichung
Country [77] 0 0
Taiwan
State/province [77] 0 0
Taipei

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Eli Lilly and Company
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to see whether teriparatide, given for 6 months versus placebo, will improve the healing of hip (femoral neck) fractures that are repaired during surgery using certain types of orthopedic screws. The study will enroll men and postmenopausal women at least 50 years of age with a recent hip (femoral neck) fracture caused by low-trauma (for example, fall from standing height or less).
Trial website
https://clinicaltrials.gov/study/NCT01473589
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Address 0 0
Eli Lilly and Company
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01473589