Clinical trial NCT01473589: Effect of Teriparatide on Hip Fracture Healing
Official title: Effect of Teriparatide on Femoral Neck Fracture Healing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Femur Neck Fracture
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2011-11-17
Enrollment: 122
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants With No Revision Surgery at 12 Months After Internal Fixation of a Low-Trauma Femoral Neck Fracture
timeFrame: 12 months
Secondary outcomes:
measure: Percentage of Participants With Radiographic Evidence of Healing
timeFrame: Randomization up to 12 months
measure: Percentage of Participants With Pain Control During Ambulation
timeFrame: Up to 12 months
measure: Percentage of Participants Without Severe Fracture-Site Pain During 24 Hours Prior to Visit
timeFrame: Up to 12 months
measure: Percentage of Participants Without Severe Fracture-Site Pain During Weight Bearing
timeFrame: Up to 12 months
measure: Percentage of Participants With Functional Evidence of Healing
timeFrame: 12 Months
measure: Percentage of Participants Able to Ambulate
timeFrame: Up to 12 months
measure: Percentage of Participants Who Regain Their Prefracture Ambulatory Status
timeFrame: Up to 12 months
measure: Mean Change From Baseline to 6 Months in Worst Fracture-Site Pain
timeFrame: Baseline, 6 Months
measure: Mean Change From Baseline to 6 Months in Gait Speed
timeFrame: Baseline, up to 6 Months
measure: Time to Revision Surgery
timeFrame: Baseline to revision surgery (up to 14.14 Months)
measure: Mean Change From Baseline to 6 Months on Short Form-12 (SF-12) Physical (PCS) and Mental Component Summary (MCS) Scores
timeFrame: Baseline, up to 6 Months
measure: Mean Change From Baseline to 6 Months on Western Ontario McMaster Osteoarthritis Index (WOMAC)
timeFrame: Baseline, up to 6 Months
measure: Mean Change From Baseline to 6 Months on European Quality of Life Questionnaire (EQ-5D) Health State Score
timeFrame: Baseline, up to 6 Months
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: 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.
state: Arizona
city: Tucson
country: United States
facility: 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.
state: Arizona
city: La Mesa
country: United States
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state: California
city: Laguna Hills
country: United States
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state: California
city: Lancaster
country: United States
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state: California
city: Pasadena
country: United States
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state: California
city: Danbury
country: United States
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state: Connecticut
city: Boca Raton
country: United States
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state: Florida
city: Bradenton
country: United States
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state: Florida
city: Miami
country: United States
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state: Florida
city: Orlando
country: United States
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state: Florida
city: Idaho Falls
country: United States
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state: Idaho
city: Royal Oak
country: United States
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state: Michigan
city: Columbia
country: United States
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state: Missouri
city: Springfield
country: United States
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state: Missouri
city: Billings
country: United States
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state: Montana
city: Great Falls
country: United States
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state: Montana
city: Omaha
country: United States
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state: Nebraska
city: Asheville
country: United States
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state: North Carolina
city: Fargo
country: United States
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state: North Dakota
city: York
country: United States
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state: Pennsylvania
city: Houston
country: United States
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state: Texas
city: San Antonio
country: United States
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state: Texas
city: Salt Lake City
country: United States
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state: Utah
city: Penrith
country: Australia
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state: New South Wales
city: Heidelberg
country: Australia
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state: Victoria
city: St Albans
country: Australia
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state: Victoria
city: Nedlands
country: Australia
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state: Western Australia
city: Newmarket
country: Canada
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state: Ontario
city: St. Catharines
country: Canada
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state: Ontario
city: St-Jerome
country: Canada
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state: Quebec
city: Aarhus
country: Denmark
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city: Hillerod
country: Denmark
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city: Kobenhavn
country: Denmark
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city: Koege
country: Denmark
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city: Tartu
country: Estonia
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city: Oulu
country: Finland
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city: Turku
country: Finland
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city: Hong Kong
country: Hong Kong
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city: Ahmedabad
country: India
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city: Attavar, Mangalore
country: India
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city: Bangalore
country: India
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city: Hyderabaad
country: India
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city: Nagpur
country: India
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city: Vadodara
country: India
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city: Haifa
country: Israel
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city: Jerusalem
country: Israel
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city: Aichi
country: Japan
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city: Chiba
country: Japan
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city: Fukuoka
country: Japan
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city: Fukushima
country: Japan
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city: Gunma
country: Japan
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city: Hiroshima
country: Japan
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city: Ibaraki
country: Japan
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city: Japan
country: Japan
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city: Kagawa
country: Japan
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city: Nagano
country: Japan
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city: Niigata
country: Japan
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city: Ohita
country: Japan
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city: Osaka
country: Japan
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city: Saga
country: Japan
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city: Shimane
country: Japan
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city: Shizuoka
country: Japan
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city: Toyama
country: Japan
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city: Toyko
country: Japan
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city: Yamaguchi
country: Japan
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city: Yamanashi
country: Japan
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city: Seongnam-Si
country: Korea, Republic of
facility: 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.
city: Seoul
country: Korea, Republic of
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city: Riga
country: Latvia
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city: Kaunas
country: Lithuania
facility: 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.
city: Klaipeda
country: Lithuania
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city: Vilnius
country: Lithuania
facility: 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.
city: Christchurch
country: New Zealand
facility: 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.
city: Takapuna
country: New Zealand
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city: Wellington South
country: New Zealand
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city: Toensberg
country: Norway
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city: San Juan
country: Puerto Rico
facility: 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.
city: Alcira
country: Spain
facility: 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.
city: Barcelona
country: Spain
facility: 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.
city: Girona
country: Spain
facility: 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.
city: Guadalajara
country: Spain
facility: 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.
city: Marbella
country: Spain
facility: 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.
city: Pozuelo De Alarcon
country: Spain
facility: 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.
city: Malmo
country: Sweden
facility: 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.
city: Mölndal
country: Sweden
facility: 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.
city: Stockholm
country: Sweden
facility: 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.
city: Jhonghe City
country: Taiwan
facility: 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.
city: Kaohsiung
country: Taiwan
facility: 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.
city: Taichung City
country: Taiwan
facility: 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.
city: Taichung
country: Taiwan
facility: 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.
city: Taipei
country: Taiwan
facility: 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.
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References: