Femur Neck FracturePhase 3NCT01473589
Effect of Teriparatide on Hip Fracture Healing
A Phase 3 study testing Teriparatide, Calcium supplementation and Vitamin D supplementation in people with Femur Neck Fracture, run by Eli Lilly and Company at 92 sites in 19 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Femur Neck Fracture
- What is being tested?
- Teriparatide, Calcium supplementation and Vitamin D supplementation
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 122 participants
- Where
- 92 sitesin 19 countries
- Study dates
- Feb 2012to Dec 2013
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 20Show fewer
- 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
Trial locations and contacts
92 sites in 19 countries.
92 sites in 19 countries
United States24 sites
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Asheville, North Carolina, 28801
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Billings, Montana, 59101
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Boca Raton, Florida, 33486
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Bradenton, Florida, 34209
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Columbia, Missouri, 65212
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Danbury, Connecticut, 06810
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Fargo, North Dakota, 58103
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Great Falls, Montana, 59405
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Houston, Texas, 77043
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Idaho Falls, Idaho, 83404
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La Mesa, California, 91942
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Laguna Hills, California, 92653
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Lancaster, California, 93534
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Miami, Florida, 33136
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Omaha, Nebraska, 68131
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Orlando, Florida, 32804
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Pasadena, California, 91101
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Phoenix, Arizona, 85027
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Royal Oak, Michigan, 48073
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Salt Lake City, Utah, 84108
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San Antonio, Texas, 78229
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Springfield, Missouri, 65804
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Tucson, Arizona, 85712
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York, Pennsylvania, 17405
Japan20 sites
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Aichi, 465-8620
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Chiba, 275-8580
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Fukuoka, 831-0016
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Fukushima, 961
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Gunma, 371-0014
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Hiroshima, 739-0696
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Ibaraki, 305-0854
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Japan, 399-8292
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Kagawa, 765-8507
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Nagano, 390-8510
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Niigata, 950-1197
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Ohita, 874-0011
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Osaka, 586-8521
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Saga, 840
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Shimane, 697-8511
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Shizuoka, 411-8611
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Toyama, 939-1395
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Toyko, 208-0011
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Yamaguchi, 754-0002
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Yamanashi, 400-8506
India6 sites
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Ahmedabad, 532004
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Attavar, Mangalore, 575001
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Bangalore, 560 054
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Hyderabaad, 500033
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Nagpur, 444001
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Vadodara, 390018
Spain6 sites
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Alzira, 46600
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Barcelona, 08025
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Girona, 17007
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Guadalajara, 19002
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Marbella, 29600
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Pozuelo de Alarcón, 28223
Taiwan5 sites
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Kaohsiung City, 824
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Taichung, 40201
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Taichung, 40705
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Taipei, 220
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Zhonghe, 235
Australia4 sites
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Heidelberg, Victoria, 3081
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Nedlands, Western Australia, 6009
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Penrith, New South Wales, 2751
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St Albans, Victoria, 3021
Denmark4 sites
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Aarhus, 8000
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Copenhagen, 2400
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Hillerød, Dk-3400
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Koege, 4600
Canada3 sites
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Newmarket, Ontario, L3Y 2P9
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Saint-Jérôme, Quebec, J7Z 5T3
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St. Catharines, Ontario, L2R 5J7
Lithuania3 sites
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Kaunas, 44320
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Klaipėda, 92228
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Vilnius, 04130
New Zealand3 sites
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Christchurch, 8022
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Takapuna, 0622
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Wellington South, 6021
Sweden3 sites
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Malmö, 205 02
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Mölndal, 43180
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Stockholm, SE-118 83
Finland2 sites
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Oulu, 90229
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Turku, SF-20520
Israel2 sites
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Haifa, 31096
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Jerusalem, 91240
South Korea2 sites
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Seongnam-si, 463-707
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Seoul, 135 720
Estonia1 site
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Tartu, 51014
Hong Kong1 site
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Hong Kong
Latvia1 site
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Riga, 1005
Norway1 site
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Tønsberg, NO-3103
Puerto Rico1 site
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.
San Juan, 00936-5067
About this study
Official title: Effect of Teriparatide on Femoral Neck Fracture Healing
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).
Read the detailed description
This is a 12-month, Phase 3, prospective, randomized, parallel, double-blind, placebo-controlled, multicenter, multinational study to evaluate the effect of 6 months of treatment with teriparatide on fracture healing in participants who have sustained a recent low-trauma, unilateral, femoral neck fracture stabilized by internal fixation. The study has 3 periods:
- A screening period that must be completed in ≤ 14 days after operative treatment of the femoral neck fracture
- A 6-month double-blind treatment period [teriparatide 20 µg or placebo given once daily by SC injection]
- A 6-month observation period.
The primary objective is to assess the effect of 6 months of treatment with teriparatide 20 µg/day versus placebo on the proportion of men and postmenopausal women of at least 50 years of age with no revision surgery 12 months after internal fixation of a low-trauma femoral neck fracture.
All participants will receive supplements of calcium and vitamin D beginning at screening and continuing for 12 months.
- Conditions
- Femur Neck Fracture
- Being tested
- Teriparatide, Placebo, Calcium supplementation, Vitamin D supplementation
- Medical subject headings
- Femoral Neck Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TeriparatideDrug
Also called Forteo, Forsteo, LY333334
Administered by SC injection
PlaceboDrug
Administered by SC injection
Calcium supplementationDietary supplement
Administered orally
Vitamin D supplementationDietary supplement
Administered orally
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Administered once daily by subcutaneous (SC) injection for 6 months Receives: Drug: Placebo; Dietary Supplement: Calcium supplementation; Dietary Supplement: Vitamin D supplementation |
| Teriparatide | Experimental | 20 microgram (µg) administered once daily by SC injection for 6 months Receives: Drug: Teriparatide; Dietary Supplement: Calcium supplementation; Dietary Supplement: Vitamin D supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With No Revision Surgery at 12 Months After Internal Fixation of a Low-Trauma Femoral Neck Fracture
Revision surgery (re-operation) was defined as any additional surgical intervention performed or recommended at the site of the index procedure, except those that were planned at the time of the index procedure.
Measured: 12 months
Secondary outcomes (13)
Percentage of Participants With Radiographic Evidence of Healing
The signs of femoral neck fracture healing included disappearance of the fracture line on radiographs. If a participant had radiographic evidence of healing at the 12-month visit, that participant was considered to have radiographic evidence of healing.
Percentage was calculated as: (number of participants with radiographic evidence of healing / total number of participants analyzed) * 100.
Measured: Randomization up to 12 months
Percentage of Participants With Pain Control During Ambulation
The worst pain numeric rating scale (NRS) was used to assess the impact of pain on a participant's life. NRS Item 3 assessed the worst musculoskeletal pain severity during the walking test. Pain was measured by an 11-point Likert scale. The following cut-points were used to categorize the NRS responses: 0 = no pain, 1 to 4 = mild pain, 5 to 6 = moderate pain, and 7 to 10 = severe pain. Participants with an NRS score of <7 were categorized as having no severe fracture-site pain with ambulation and no worsening of NRS scores >2 from baseline. Percentage was calculated as: (Number of participants with pain control during ambulation / total number of participants) * 100.
Measured: Up to 12 months
Percentage of Participants Without Severe Fracture-Site Pain During 24 Hours Prior to Visit
The worst pain NRS was used to assess the impact of pain on a participant's life. Fracture-site pain severity was assessed for pain in the 24 hours preceding a visit. Pain was measured by an 11-point Likert scale. Participants with an NRS score of <7 in the 24 hours preceding a visit and no worsening of NRS >2 from baseline were categorized as having no severe fracture-site pain. Percentage was calculated as: (number of participants with pain control during 24 hours preceding a visit / total number of participants) * 100.
Measured: Up to 12 months
Percentage of Participants Without Severe Fracture-Site Pain During Weight Bearing
The worst pain NRS was used to assess the impact of pain on a participant's life. Fracture-site pain severity was assessed for pain on weight bearing. Pain was measured by an 11-point Likert scale. Participants with an NRS score of <7 during weight bearing and no worsening of NRS >2 from baseline were categorized as having no severe fracture-site pain. Percentage was calculated as: (number of participants with pain control during weight bearing / total number of participants) * 100.
Measured: Up to 12 months
Percentage of Participants With Functional Evidence of Healing
Functional healing was defined as ability to walk with a gait speed ≥ 0.05 meters/second (m/s) with a change from baseline ≥ -0.1 m/s. The walking test involved having the participant walk a distance of 7 meters (m) at a self-selected, comfortable pace. A 4-m portion of the test was timed to determine the participant's gait speed in m/s.
Percentage was calculated as: (number of participants with functional evidence of healing / total number of participants analyzed) * 100.
Measured: 12 Months
Percentage of Participants Able to Ambulate
Ability to ambulate was defined as ambulatory with convalescent aid or without convalescent aid. Percentage was calculated as: (number of participants able to ambulate / number of total participants analyzed) * 100.
Measured: Up to 12 months
Percentage of Participants Who Regain Their Prefracture Ambulatory Status
Prefracture ambulatory status was defined as either ambulatory with or without a walking aid. A participant was considered to have regained their prefracture ambulatory status if the participant's postsurgery ambulatory status was returned to or was improved from their pre-surgery ambulatory status. Percentage was calculated as = (number of participants who regained their ambulatory status / total number analyzed) * 100.
Measured: Up to 12 months
Mean Change From Baseline to 6 Months in Worst Fracture-Site Pain
The worst pain NRS was used to assess the impact of pain on a participant's life. Participants with an NRS score of <7 were categorized as having no severe fracture-site pain. Least Squares (LS) means was calculated using analysis of covariance (ANCOVA) and adjusted for baseline, treatment group, region, fracture type, and fixation type.
Measured: Baseline, 6 Months
Mean Change From Baseline to 6 Months in Gait Speed
The walking test involved having the participant walk a distance of 7 m at a self-selected, comfortable pace. A 4-m portion of the test was timed to determine the participant's gait speed in m/s. LS means was calculated using ANCOVA and adjusted for baseline, treatment group, region, fracture type, and fixation type.
Measured: Baseline, up to 6 Months
Time to Revision Surgery
Time to revision surgery was defined as the time from initial hip fracture surgery to revision surgery, or recommendation for revision surgery if recommended but not performed. Time to revision surgery was censored at the date of the last contact.
Measured: Baseline to revision surgery (up to 14.14 Months)
Mean Change From Baseline to 6 Months on Short Form-12 (SF-12) Physical (PCS) and Mental Component Summary (MCS) Scores
SF-12 is a self-reported questionnaire covering a mental component score (MCS) and a physical component score (PCS), each scoring from a 0 to 100 (worst to best) scale. LS mean was calculated using ANCOVA and adjusted for baseline, treatment group, region, fracture type, fixation type, visit, and visit-by-treatment interaction.
Measured: Baseline, up to 6 Months
Mean Change From Baseline to 6 Months on Western Ontario McMaster Osteoarthritis Index (WOMAC)
WOMAC is: a self-reported questionnaire that consisted of 24 questions covering 3 health domains: Pain (5 items: during walking, using stairs, in bed, sitting or lying, and standing), Stiffness (2 items: after first waking and later in the day), and Physical Function. Each domain was scored by summing the individual items and transforming the scores into a 0 to 100 (best to worst) scale. LS mean was calculated using ANCOVA and adjusted for baseline, treatment group, region, fracture type, fixation type, visit, and visit-by-treatment interaction.
Measured: Baseline, up to 6 Months
Mean Change From Baseline to 6 Months on European Quality of Life Questionnaire (EQ-5D) Health State Score
The EQ-5D is a 5-item, self-reported, generic, multidimensional, health-related, quality-of-life instrument with 5 items. Overall health state score was also self-reported using a visual analogue scale (VAS) marked on a scale scored from 0 (worse imaginable health state) to 100 (best imaginable health state). LS mean was calculated using ANCOVA and adjusted for baseline, treatment group, and region.
Measured: Baseline, up to 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2011 (estimated)
- Study startFeb 2012
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Femur Neck FractureStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01473589
- Sponsor's protocol ID
- 13467
- Other IDs
- B3D-MC-GHDN
- Status last verified
- Apr 2015
- First submitted
- 14 Nov 2011
- Last updated
- 16 Apr 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Teriparatide on Femoral Neck Fracture Healing
- ClinicalTrials.gov ID
- NCT01473589
- Acronym / sponsor ID
- 13467
- Conditions
- Femur Neck Fracture
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Feb 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 17 Nov 2011 (estimated)
- Results
- Posted 17 Nov 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
This is a 12-month, Phase 3, prospective, randomized, parallel, double-blind, placebo-controlled, multicenter, multinational study to evaluate the effect of 6 months of treatment with teriparatide on fracture healing in participants who have sustained a recent low-trauma, unilateral, femoral neck fracture stabilized by internal fixation. The study has 3 periods:
- A screening period that must be completed in ≤ 14 days after operative treatment of the femoral neck fracture
- A 6-month double-blind treatment period [teriparatide 20 µg or placebo given once daily by SC injection]
- A 6-month observation period.
The primary objective is to assess the effect of 6 months of treatment with teriparatide 20 µg/day versus placebo on the proportion of men and postmenopausal women of at least 50 years of age with no revision surgery 12 months after internal fixation of a low-trauma femoral neck fracture.
All participants will receive supplements of calcium and vitamin D beginning at screening and continuing for 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo, Dietary Supplement: Calcium supplementation, Dietary Supplement: Vitamin D supplementationAdministered once daily by subcutaneous (SC) injection for 6 months |
| Teriparatide | Experimental | Drug: Teriparatide, Dietary Supplement: Calcium supplementation, Dietary Supplement: Vitamin D supplementation20 microgram (µg) administered once daily by SC injection for 6 months |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TeriparatideAlso: Forteo, Forsteo, LY333334Administered by SC injection | Drug | Teriparatide |
| PlaceboAdministered by SC injection | Drug | Placebo |
| Calcium supplementationAdministered orally | Dietary supplement | Placebo, Teriparatide |
| Vitamin D supplementationAdministered orally | Dietary supplement | Placebo, Teriparatide |
Primary outcome
Percentage of Participants With No Revision Surgery at 12 Months After Internal Fixation of a Low-Trauma Femoral Neck Fracture
Time frame: 12 months
Revision surgery (re-operation) was defined as any additional surgical intervention performed or recommended at the site of the index procedure, except those that were planned at the time of the index procedure.
13 secondary outcomes
Percentage of Participants With Radiographic Evidence of Healing
Time frame: Randomization up to 12 months
Percentage of Participants With Pain Control During Ambulation
Time frame: Up to 12 months
Percentage of Participants Without Severe Fracture-Site Pain During 24 Hours Prior to Visit
Time frame: Up to 12 months
Percentage of Participants Without Severe Fracture-Site Pain During Weight Bearing
Time frame: Up to 12 months
Percentage of Participants With Functional Evidence of Healing
Time frame: 12 Months
Percentage of Participants Able to Ambulate
Time frame: Up to 12 months
Percentage of Participants Who Regain Their Prefracture Ambulatory Status
Time frame: Up to 12 months
Mean Change From Baseline to 6 Months in Worst Fracture-Site Pain
Time frame: Baseline, 6 Months
Mean Change From Baseline to 6 Months in Gait Speed
Time frame: Baseline, up to 6 Months
Time to Revision Surgery
Time frame: Baseline to revision surgery (up to 14.14 Months)
Mean Change From Baseline to 6 Months on Short Form-12 (SF-12) Physical (PCS) and Mental Component Summary (MCS) Scores
Time frame: Baseline, up to 6 Months
Mean Change From Baseline to 6 Months on Western Ontario McMaster Osteoarthritis Index (WOMAC)
Time frame: Baseline, up to 6 Months
Mean Change From Baseline to 6 Months on European Quality of Life Questionnaire (EQ-5D) Health State Score
Time frame: Baseline, up to 6 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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) study director
Eli Lilly and Company
92 sites in 19 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Teriparatide, Calcium supplementation and Vitamin D supplementation in people with Femur Neck Fracture, run by Eli Lilly and Company at 92 sites in 19 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 92 sites in United States, Japan, India, Spain, Taiwan and 14 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Nov 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With No Revision Surgery at 12 Months After Internal Fixation of a Low-Trauma Femoral Neck Fracture (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2015.