NCT01473589

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 Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
122

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Feb 2012

Geographic Reach
18 countries

86 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 14, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 17, 2011

Completed
3 months until next milestone

Study Start

First participant enrolled

February 1, 2012

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
12 months until next milestone

Results Posted

Study results publicly available

November 17, 2014

Completed
Last Updated

April 16, 2015

Status Verified

April 1, 2015

Enrollment Period

1.8 years

First QC Date

November 14, 2011

Results QC Date

November 10, 2014

Last Update Submit

April 10, 2015

Conditions

Femur Neck Fracture

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (13)

  • Percentage of Participants With Radiographic Evidence of Healing

    Randomization up to 12 months

  • Percentage of Participants With Pain Control During Ambulation

    Up to 12 months

  • Percentage of Participants Without Severe Fracture-Site Pain During 24 Hours Prior to Visit

    Up to 12 months

  • Percentage of Participants Without Severe Fracture-Site Pain During Weight Bearing

    Up to 12 months

  • Percentage of Participants With Functional Evidence of Healing

    12 Months

  • +8 more secondary outcomes

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Administered once daily by subcutaneous (SC) injection for 6 months

Drug: PlaceboDietary Supplement: Calcium supplementationDietary Supplement: Vitamin D supplementation

Teriparatide

EXPERIMENTAL

20 microgram (µg) administered once daily by SC injection for 6 months

Drug: TeriparatideDietary Supplement: Calcium supplementationDietary Supplement: Vitamin D supplementation

Interventions

TeriparatideDRUG

Administered by SC injection

Also known as: Forteo, Forsteo, LY333334
Teriparatide
PlaceboDRUG

Administered by SC injection

Placebo
Calcium supplementationDIETARY_SUPPLEMENT

Administered orally

PlaceboTeriparatide
Vitamin D supplementationDIETARY_SUPPLEMENT

Administered orally

PlaceboTeriparatide

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (92)

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Phoenix, Arizona, 85027, United States

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Tucson, Arizona, 85712, United States

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La Mesa, California, 91942, United States

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Laguna Hills, California, 92653, United States

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Lancaster, California, 93534, United States

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Pasadena, California, 91101, United States

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Danbury, Connecticut, 06810, United States

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Boca Raton, Florida, 33486, United States

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Bradenton, Florida, 34209, United States

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Miami, Florida, 33136, United States

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Orlando, Florida, 32804, United States

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Idaho Falls, Idaho, 83404, United States

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Royal Oak, Michigan, 48073, United States

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Columbia, Missouri, 65212, United States

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Springfield, Missouri, 65804, United States

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Billings, Montana, 59101, United States

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Great Falls, Montana, 59405, United States

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Omaha, Nebraska, 68131, United States

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Asheville, North Carolina, 28801, United States

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Fargo, North Dakota, 58103, United States

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York, Pennsylvania, 17405, United States

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Houston, Texas, 77043, United States

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San Antonio, Texas, 78229, United States

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Salt Lake City, Utah, 84108, United States

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Penrith, New South Wales, 2751, Australia

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Heidelberg, Victoria, 3081, Australia

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St Albans, Victoria, 3021, Australia

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Nedlands, Western Australia, 6009, Australia

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Newmarket, Ontario, L3Y 2P9, Canada

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St. Catharines, Ontario, L2R 5J7, Canada

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Saint-Jérôme, Quebec, J7Z 5T3, Canada

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Aarhus, 8000, Denmark

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Copenhagen, 2400, Denmark

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Hillerød, Dk-3400, Denmark

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Koege, 4600, Denmark

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Tartu, 51014, Estonia

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Oulu, 90229, Finland

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Turku, SF-20520, Finland

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Hong Kong, Hong Kong

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Ahmedabad, 532004, India

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Attavar, Mangalore, 575001, India

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Bangalore, 560 054, India

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Hyderabaad, 500033, India

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Nagpur, 444001, India

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Vadodara, 390018, India

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Haifa, 31096, Israel

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Jerusalem, 91240, Israel

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Aichi, 465-8620, Japan

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Chiba, 275-8580, Japan

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Fukuoka, 831-0016, Japan

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Fukushima, 961, Japan

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Gunma, 371-0014, Japan

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Hiroshima, 739-0696, Japan

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Ibaraki, 305-0854, Japan

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Japan, 399-8292, Japan

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Kagawa, 765-8507, Japan

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Nagano, 390-8510, Japan

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Niigata, 950-1197, Japan

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Ohita, 874-0011, Japan

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Osaka, 586-8521, Japan

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Saga, 840, Japan

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Shimane, 697-8511, Japan

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Shizuoka, 411-8611, Japan

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Toyama, 939-1395, Japan

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Toyko, 208-0011, Japan

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Yamaguchi, 754-0002, Japan

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Yamanashi, 400-8506, Japan

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Riga, 1005, Latvia

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Kaunas, 44320, Lithuania

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Klaipėda, 92228, Lithuania

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Vilnius, 04130, Lithuania

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Christchurch, 8022, New Zealand

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Takapuna, 0622, New Zealand

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Wellington South, 6021, New Zealand

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Tønsberg, NO-3103, Norway

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San Juan, 00936-5067, Puerto Rico

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Seongnam-si, 463-707, South Korea

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Seoul, 135 720, South Korea

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Alzira, 46600, Spain

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Barcelona, 08025, Spain

Location

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Girona, 17007, Spain

Location

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Guadalajara, 19002, Spain

Location

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Marbella, 29600, Spain

Location

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Pozuelo de Alarcón, 28223, Spain

Location

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Malmo, 205 02, Sweden

Location

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Mölndal, 43180, Sweden

Location

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Stockholm, SE-118 83, Sweden

Location

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Kaohsiung City, 824, Taiwan

Location

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Taichung, 40201, Taiwan

Location

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Taichung, 40705, Taiwan

Location

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Taipei, 220, Taiwan

Location

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Zhonghe, 235, Taiwan

Location

MeSH Terms

Conditions

Femoral Neck Fractures

Interventions

Teriparatide

Condition Hierarchy (Ancestors)

Hip FracturesFemoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Intervention Hierarchy (Ancestors)

Parathyroid HormonePeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Results Point of Contact

Title
Chief Medical Officer
Organization
Eli Lilly and Company
800-545-5979

Study Officials

  • 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)

    Eli Lilly and Company

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 14, 2011

First Posted

November 17, 2011

Study Start

February 1, 2012

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

April 16, 2015

Results First Posted

November 17, 2014

Record last verified: 2015-04

Locations

LA(1)IL(2)PR(1)NO(1)ES(1)LI(3)DK(4)IN(6)AU(4)HK(1)KR(2)TW(5)SE(3)US(24)NZ(3)JP(20)FI(2)CA(3)