Femur Neck FracturePhase 3NCT01473602

Second Study of the 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 75 sites in 14 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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: 39 participants
Where: 75 sitesin 14 countries
Study dates: Jan 2012to Nov 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

75 sites in 14 countries.

Country

City, postcode or hospital

75 sites in 14 countries

United States19 sites

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Charleston, South Carolina, 29425
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Charlotte, North Carolina, 28204
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Charlottesville, Virginia, 22903
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Danville, Pennsylvania, 17822
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Detroit, Michigan, 48202
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Durham, North Carolina, 27710
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Falls Church, Virginia, 22042
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Gainesville, Georgia, 30501
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Golden, Colorado, 80401
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Indianapolis, Indiana, 46278
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Johnson City, Tennessee, 37604
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Memphis, Tennessee, 38163
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Morton Grove, Illinois, 60053
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New Hyde Park, New York, 11040
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New York, New York, 10075
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Pittsburgh, Pennsylvania, 15212
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Rockford, Illinois, 61107
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San Diego, California, 92103
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Washington D.C., District of Columbia, 20037

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Germany9 sites

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Berlin, 12683
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Cologne, 50931
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Dresden, 01307
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Freiburg im Breisgau, 79106
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Göttingen, 37075
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Hamburg, 20251
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Leipzig, 04103
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Marburg, 35043
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Regensburg, 93053

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Belgium6 sites

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Aalst, 9300
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Blankenberge, 8370
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Brussels, 1070
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Genk, 3600
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Gilly, 6060
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Leuven, 3000

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Hungary6 sites

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Budapest, 1036
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Eger, 3300
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Hatvan, 3000
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Kaposvár, 7400
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Sopron, 9400
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Szeged, 6725

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India6 sites

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Attavar, Mangalore, 575001
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Bangalore, 560 054
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Hyderabaad, 500003
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New Delhi, 110 060
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Pune, 41005
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Trivandrum, 695004

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Croatia5 sites

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Osijek, 31000
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Rijeka, HR-51000
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Sisak, 44000
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Slavonski Brod, 35000
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Zagreb, 10000

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France4 sites

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La Roche-sur-Yon, 85925
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Orléans, 45000
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Saint-Etienne, 42055
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Toulouse, 31059

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Greece4 sites

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Haidari/Athens, 12462
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Kifissia, 14561
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Pátrai, 26500
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Thessaloniki, 56429

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South Korea4 sites

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Busan, 612-030
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Daegu, 700-712
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Seoul, 134-727
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Suwon, 442-721

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Romania3 sites

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Bucharest, 021659
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Cluj-Napoca, 400132
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Timișoara, 300736

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Turkey (Türkiye)3 sites

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Ankara, 06010
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Istanbul, 34755
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Izmir, 35550

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Netherlands2 sites

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Maastricht, 6202 AZ
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Zwolle, 8025 AB

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Poland2 sites

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Lublin, 20-826
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Warsaw, PL-02-0500

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Switzerland2 sites

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Basel, CH-4031
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Lausanne, 1011

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About this study

Official title: Second Study of the 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 subcutaneous 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 groups in NCT01473602
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 and healing complications 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. Higher scores indicated more severe pain. Participants with an NRS score of <7 and no worsening of NRS scores >2 from baseline were categorized as having no severe fracture-site pain. Percentage was calculated as: (number of participants with pain control during ambulation / total number of participants analyzed) * 100.
Measured: Up to 12 months
Percentage of Participants Without Severe Fracture-Site Pain During 24 Hours Prior to Visit
The 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 score >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 analyzed) * 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 score >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: Up to 12 Months
Percentage of Participants Able to Ambulate
Ability to ambulate was defined as ambulatory with or without convalescent aid. Percentage was calculated as: (number of participants able to ambulate / total number of participants analyzed) * 100.
Measured: Up to 12 months
Percentage of Participants Who Regained 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 of participants 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) 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 adjusted for baseline, treatment group, region, fracture type, and fixation type
Measured: Baseline, 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 means was calculated using ANCOVA adjusted for baseline, treatment group, region, fracture type, fixation type, visit, and visit-by-treatment interaction.
Measured: Baseline, 6 Months
Mean Change From Baseline to 6 Months on Western Ontario McMaster Osteoarthritis Index (WOMAC)
WOMAC: was 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. Lower scores indicated better health status or functioning. LS means was calculated using ANCOVA 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) Overall Health 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 (worst imaginable health state) to 100 (best imaginable health state). Higher scores represented better health state with 0 representing worst imaginable health state and 100 representing best imaginable health state. LS means was calculated using ANCOVA adjusted for baseline, treatment group, region.
Measured: Baseline, 6 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2012Nov 2013

First posted17 Nov 2011 (estimated)
Study startJan 2012
Primary completionNov 2013
Study completionNov 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: 39 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01473602
Sponsor's protocol ID: 14125
Other IDs: B3D-MC-GHDQ
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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Femur Neck Fracture trials

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: Second Study of the Effect of Teriparatide on Femoral Neck Fracture Healing
ClinicalTrials.gov ID: NCT01473602
Acronym / sponsor ID: 14125
Conditions: Femur Neck Fracture
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 39 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Jan 2012
Primary completion: Nov 2013 (actual)
Study completion: Nov 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.

Detailed description

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 subcutaneous injection]
A 6-month observation period.

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: Up to 12 Months
Percentage of Participants Able to Ambulate
Time frame: Up to 12 months
Percentage of Participants Who Regained 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, 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, 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) Overall Health Score
Time frame: Baseline, 6 Months

Results and safety

Results posted to the registry on 17 Nov 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Teriparatide	18	10
Placebo	21	13

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. Number (90% Confidence Interval). Unit: Percentage of participants

Measure	Teriparatide n = 18	Placebo n = 20
Value	74 (51 to 88)	93 (70 to 99)

Population analysed: Participants who were randomized, received at least 1 dose of study drug.

13 secondary outcomes are reported in the full results.

Adverse events

Time frame: Randomization to Study Completion. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	2 of 20 (10%)	5 of 20 (25%)	Not reported
Teriparatide	1 of 18 (5.6%)	3 of 18 (16.7%)	Not reported
Placebo Follow-up	3 of 15 (20%)	4 of 15 (26.7%)	Not reported
Teriparatide Follow-up	1 of 12 (8.3%)	3 of 12 (25%)	Not reported

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.

Related trials for Femur Neck Fracture

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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

75 sites in 14 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 75 sites in 14 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 75 sites in United States, Germany, Belgium, Hungary, India and 9 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?

On the ClinicalTrials.gov record for NCT01473602.

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.