Second Study of the Effect of Teriparatide on Hip Fracture Healing

Condition(s) targeted: Femur Neck Fracture

Intervention: Teriparatide (Drug); Placebo (Drug); Calcium supplementation (Dietary Supplement); Vitamin D supplementation (Dietary Supplement)

Phase: Phase 3

Status: Completed

Sponsored by: Eli Lilly and Company

Official(s) and/or principal investigator(s):
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), Study Director, Affiliation: Eli Lilly and Company

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).

Official title: Second Study of the Effect of Teriparatide on Femoral Neck Fracture Healing

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: Percentage of Participants With No Revision Surgery at 12 Months After Internal Fixation of a Low-Trauma Femoral Neck Fracture

Secondary outcome:

Percentage of Participants With Radiographic Evidence of Healing

Percentage of Participants With Pain Control During Ambulation

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

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

Percentage of Participants With Functional Evidence of Healing

Percentage of Participants Able to Ambulate

Percentage of Participants Who Regained Their Prefracture Ambulatory Status

Mean Change From Baseline to 6 Months in Worst Fracture-Site Pain

Mean Change From Baseline to 6 Months in Gait Speed

Time to Revision Surgery

Mean Change From Baseline to 6 Months on Short Form-12 (SF-12) Physical (PCS) and Mental Component Summary (MCS) Scores

Mean Change From Baseline to 6 Months on Western Ontario McMaster Osteoarthritis Index (WOMAC)

Mean Change From Baseline to 6 Months on European Quality of Life Questionnaire (EQ-5D) Overall Health Score

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 subcutaneous 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.

Minimum age: 50 Years. Maximum age: N/A. Gender(s): Both.

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

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., Aalst 9300, Belgium

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Starting date: January 2012
Last updated: April 10, 2015