Effect of Teriparatide on Hip Fracture Healing

Completed · Phase 3 · Has a placebo group

Conditions studied: Femur Neck Fracture

In brief

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).

Key facts

Study ID: NCT01473589
Run by: Eli Lilly and Company
People needed: 122
Starts: 2012-02-01
Expected to finish: 2013-12-01
Last updated by the study team: 2015-04-16

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

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
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

Where it is running

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. — Tucson, Arizona, United States
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. — La Mesa, California, United States
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. — Laguna Hills, California, United States
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. — Lancaster, California, United States
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. — Pasadena, California, United States
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. — Danbury, Connecticut, United States
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. — Boca Raton, Florida, United States
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. — Bradenton, Florida, United States
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. — Miami, Florida, United States
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. — Orlando, Florida, United States
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. — Idaho Falls, Idaho, United States
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. — Royal Oak, Michigan, United States
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. — Columbia, Missouri, United States
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. — Springfield, Missouri, United States
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. — Billings, Montana, United States
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. — Great Falls, Montana, United States
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. — Omaha, Nebraska, United States
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. — Asheville, North Carolina, United States
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. — Fargo, North Dakota, United States
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. — York, Pennsylvania, United States
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. — Houston, Texas, United States
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
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. — Salt Lake City, Utah, United States
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. — Penrith, New South Wales, Australia
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. — Phoenix, Arizona, United States

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