Study Results
Results available
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View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE3
Total Enrollment
122 participants
Study Classification
INTERVENTIONAL
Study Start Date
2012-02-29
Study Completion Date
2013-12-31
Brief Summary
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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).
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Detailed Description
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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.
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.
Conditions
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Femur Neck Fracture
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
TRIPLE
Participants
Caregivers
Investigators
Study Groups
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Placebo
Administered once daily by subcutaneous (SC) injection for 6 months
Group Type
PLACEBO_COMPARATOR
Placebo
Intervention Type
DRUG
Administered by SC injection
Calcium supplementation
Intervention Type
DIETARY_SUPPLEMENT
Administered orally
Vitamin D supplementation
Intervention Type
DIETARY_SUPPLEMENT
Administered orally
Teriparatide
20 microgram (µg) administered once daily by SC injection for 6 months
Group Type
EXPERIMENTAL
Teriparatide
Intervention Type
DRUG
Administered by SC injection
Calcium supplementation
Intervention Type
DIETARY_SUPPLEMENT
Administered orally
Vitamin D supplementation
Intervention Type
DIETARY_SUPPLEMENT
Administered orally
Interventions
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Teriparatide
Administered by SC injection
Intervention Type
DRUG
Placebo
Administered by SC injection
Intervention Type
DRUG
Calcium supplementation
Administered orally
Intervention Type
DIETARY_SUPPLEMENT
Vitamin D supplementation
Administered orally
Intervention Type
DIETARY_SUPPLEMENT
Other Intervention Names
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Forteo
Forsteo
LY333334
Eligibility Criteria
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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
* 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
* 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
Minimum Eligible Age
50 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Phoenix, Arizona, United States
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Tucson, Arizona, United States
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La Mesa, California, United States
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Laguna Hills, California, United States
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Lancaster, California, United States
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Pasadena, California, United States
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Danbury, Connecticut, United States
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Boca Raton, Florida, United States
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Bradenton, Florida, United States
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Miami, Florida, United States
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Orlando, Florida, United States
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Idaho Falls, Idaho, United States
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Royal Oak, Michigan, United States
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Columbia, Missouri, United States
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Springfield, Missouri, United States
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Billings, Montana, United States
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Great Falls, Montana, United States
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Omaha, Nebraska, United States
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Asheville, North Carolina, United States
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Fargo, North Dakota, United States
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York, Pennsylvania, United States
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Houston, Texas, United States
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San Antonio, Texas, United States
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Salt Lake City, Utah, United States
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Penrith, New South Wales, Australia
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Heidelberg, Victoria, Australia
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St Albans, Victoria, Australia
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Nedlands, Western Australia, Australia
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Newmarket, Ontario, Canada
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St. Catharines, Ontario, Canada
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Saint-Jérôme, Quebec, Canada
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Aarhus, , Denmark
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Copenhagen, , Denmark
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Hillerød, , Denmark
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Koege, , Denmark
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Tartu, , Estonia
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Oulu, , Finland
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Turku, , Finland
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Hong Kong, , Hong Kong
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Ahmedabad, , India
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Attavar, Mangalore, , India
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Bangalore, , India
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Hyderabaad, , India
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Nagpur, , India
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Vadodara, , India
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Haifa, , Israel
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Jerusalem, , Israel
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Aichi, , Japan
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Chiba, , Japan
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Fukuoka, , Japan
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Fukushima, , Japan
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Gunma, , Japan
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Hiroshima, , Japan
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Ibaraki, , Japan
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Japan, , Japan
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Kagawa, , Japan
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Nagano, , Japan
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Niigata, , Japan
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Ohita, , Japan
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Osaka, , Japan
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Saga, , Japan
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Shimane, , Japan
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Shizuoka, , Japan
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Toyama, , Japan
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Toyko, , Japan
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Yamaguchi, , Japan
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Yamanashi, , Japan
Site Status
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Riga, , Latvia
Site Status
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Kaunas, , Lithuania
Site Status
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Klaipėda, , Lithuania
Site Status
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Vilnius, , Lithuania
Site Status
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Christchurch, , New Zealand
Site Status
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Takapuna, , New Zealand
Site Status
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Wellington South, , New Zealand
Site Status
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Tønsberg, , Norway
Site Status
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San Juan, , Puerto Rico
Site Status
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Seongnam-si, , South Korea
Site Status
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Seoul, , South Korea
Site Status
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Alzira, , Spain
Site Status
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Barcelona, , Spain
Site Status
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Girona, , Spain
Site Status
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Guadalajara, , Spain
Site Status
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Marbella, , Spain
Site Status
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Pozuelo de Alarcón, , Spain
Site Status
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Malmo, , Sweden
Site Status
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Mölndal, , Sweden
Site Status
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Stockholm, , Sweden
Site Status
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Kaohsiung City, , Taiwan
Site Status
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Taichung, , Taiwan
Site Status
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Taichung, , Taiwan
Site Status
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Taipei, , Taiwan
Site Status
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Zhonghe, , Taiwan
Site Status
Countries
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United States
Australia
Canada
Denmark
Estonia
Finland
Hong Kong
India
Israel
Japan
Latvia
Lithuania
New Zealand
Norway
Puerto Rico
South Korea
Spain
Sweden
Taiwan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
B3D-MC-GHDN
Identifier Type: OTHER
Identifier Source: secondary_id
13467
Identifier Type: -
Identifier Source: org_study_id
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