Effect of Teriparatide on Hip Fracture Healing

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).

Study Overview

• Status: Completed
• Conditions: Femur Neck Fracture
• Intervention / Treatment: Drug: Placebo; Dietary supplement: Calcium supplementation; Dietary supplement: Vitamin D supplementation; Drug: Teriparatide

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:

1. A screening period that must be completed in ≤ 14 days after operative treatment of the femoral neck fracture
2. A 6-month double-blind treatment period [teriparatide 20 µg or placebo given once daily by SC injection]
3. 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 Type: Interventional
• Enrollment (Actual): 122
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Penrith, New South Wales, Australia, 2751
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  • Victoria
    • Heidelberg, Victoria, Australia, 3081
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    • St Albans, Victoria, Australia, 3021
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  • Western Australia
    • Nedlands, Western Australia, Australia, 6009
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• Canada
  • Ontario
    • Newmarket, Ontario, Canada, L3Y 2P9
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    • St. Catharines, Ontario, Canada, L2R 5J7
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  • Quebec
    • St-Jerome, Quebec, Canada, J7Z 5T3
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• Denmark
  • Aarhus, Denmark, 8000
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  • Hillerod, Denmark, Dk-3400
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  • Kobenhavn, Denmark, 2400
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  • Koege, Denmark, 4600
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• Estonia
  • Tartu, Estonia, 51014
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• Finland
  • Oulu, Finland, 90229
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  • Turku, Finland, SF-20520
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• Hong Kong
  • Hong Kong, Hong Kong
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• India
  • Ahmedabad, India, 532004
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  • Attavar, Mangalore, India, 575001
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  • Bangalore, India, 560 054
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  • Hyderabaad, India, 500033
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  • Nagpur, India, 444001
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  • Vadodara, India, 390018
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• Israel
  • Haifa, Israel, 31096
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  • Jerusalem, Israel, 91240
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• Japan
  • Aichi, Japan, 465-8620
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  • Chiba, Japan, 275-8580
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  • Fukuoka, Japan, 831-0016
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  • Fukushima, Japan, 961
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  • Gunma, Japan, 371-0014
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  • Hiroshima, Japan, 739-0696
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  • Ibaraki, Japan, 305-0854
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  • Japan, Japan, 399-8292
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  • Kagawa, Japan, 765-8507
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  • Nagano, Japan, 390-8510
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  • Niigata, Japan, 950-1197
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  • Ohita, Japan, 874-0011
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  • Osaka, Japan, 586-8521
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  • Saga, Japan, 840
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  • Shimane, Japan, 697-8511
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  • Shizuoka, Japan, 411-8611
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  • Toyama, Japan, 939-1395
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  • Toyko, Japan, 208-0011
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  • Yamaguchi, Japan, 754-0002
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  • Yamanashi, Japan, 400-8506
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• Korea, Republic of
  • Seongnam-Si, Korea, Republic of, 463-707
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  • Seoul, Korea, Republic of, 135 720
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• Latvia
  • Riga, Latvia, 1005
    • 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.
• Lithuania
  • Kaunas, Lithuania, 44320
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  • Klaipeda, Lithuania, 92228
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  • Vilnius, Lithuania, 04130
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• New Zealand
  • Christchurch, New Zealand, 8022
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  • Takapuna, New Zealand, 0622
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  • Wellington South, New Zealand, 6021
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• Norway
  • Toensberg, Norway, NO-3103
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• Puerto Rico
  • San Juan, Puerto Rico, 00936-5067
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• Spain
  • Alcira, Spain, 46600
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  • Barcelona, Spain, 08025
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  • Girona, Spain, 17007
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  • Guadalajara, Spain, 19002
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  • Marbella, Spain, 29600
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  • Pozuelo De Alarcon, Spain, 28223
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• Sweden
  • Malmo, Sweden, 205 02
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  • Mölndal, Sweden, 43180
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  • Stockholm, Sweden, SE-118 83
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• Taiwan
  • Jhonghe City, Taiwan, 235
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  • Kaohsiung, Taiwan, 824
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  • Taichung, Taiwan, 40705
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  • Taichung City, Taiwan, 40201
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  • Taipei, Taiwan, 220
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• United States
  • Arizona
    • Phoenix, Arizona, United States, 85027
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    • Tucson, Arizona, United States, 85712
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  • California
    • La Mesa, California, United States, 91942
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    • Laguna Hills, California, United States, 92653
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    • Lancaster, California, United States, 93534
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    • Pasadena, California, United States, 91101
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  • Connecticut
    • Danbury, Connecticut, United States, 06810
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  • Florida
    • Boca Raton, Florida, United States, 33486
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    • Bradenton, Florida, United States, 34209
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    • Miami, Florida, United States, 33136
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    • Orlando, Florida, United States, 32804
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  • Idaho
    • Idaho Falls, Idaho, United States, 83404
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  • Michigan
    • Royal Oak, Michigan, United States, 48073
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  • Missouri
    • Columbia, Missouri, United States, 65212
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    • Springfield, Missouri, United States, 65804
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  • Montana
    • Billings, Montana, United States, 59101
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    • Great Falls, Montana, United States, 59405
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  • Nebraska
    • Omaha, Nebraska, United States, 68131
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  • North Carolina
    • Asheville, North Carolina, United States, 28801
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  • North Dakota
    • Fargo, North Dakota, United States, 58103
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  • Pennsylvania
    • York, Pennsylvania, United States, 17405
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  • Texas
    • Houston, Texas, United States, 77043
      • 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 Antonio, Texas, United States, 78229
      • 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.
  • Utah
    • Salt Lake City, Utah, United States, 84108
      • 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.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Administered once daily by subcutaneous (SC) injection for 6 months	Drug: Placebo; Administered by SC injection; Dietary supplement: Calcium supplementation; Administered orally; Dietary supplement: Vitamin D supplementation; Administered orally
Experimental: Teriparatide; 20 microgram (µg) administered once daily by SC injection for 6 months	Dietary supplement: Calcium supplementation; Administered orally; Dietary supplement: Vitamin D supplementation; Administered orally; Drug: Teriparatide; Administered by SC injection; Other Names: Forteo; LY333334; Forsteo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	Baseline, up to 6 Months

Collaborators and Investigators

• Sponsor: Eli Lilly and Company

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: November 14, 2011
• First Submitted That Met QC Criteria: November 14, 2011
• First Posted (Estimate): November 17, 2011

Study Record Updates

• Last Update Posted (Estimate): April 16, 2015
• Last Update Submitted That Met QC Criteria: April 10, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Femoral Fractures; Hip Injuries; Hip Fractures; Fractures, Bone; Femoral Neck Fractures; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Calcium; Teriparatide
• Other Study ID Numbers: 13467; B3D-MC-GHDN (Other Identifier: Eli Lilly and Company)