Effect of Teriparatide on Hip Fracture Healing

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01473589
First received: November 14, 2011
Last updated: January 6, 2014
Last verified: January 2014

November 14, 2011
January 6, 2014
February 2012
December 2013   (final data collection date for primary outcome measure)
Proportion of Participants with No Revision Surgery at 12 Months After Internal Fixation of a Low-Trauma Femoral Neck Fracture [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
Percentage of participants with successful femoral neck fracture healing at 24 months [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01473589 on ClinicalTrials.gov Archive Site
  • Percentage of Participants with Radiographic Evidence of Healing [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
  • Percentage of Participants with Functional Evidence of Healing [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
  • Percentage of Participants with Pain Control During Ambulation [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
  • Percentage of Participants Able to Ambulate [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
  • Percentage of Participants Without Severe Fracture-Site Pain [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
  • Percentage of Participants Who Regain Their Prefracture Ambulatory Status [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
  • Mean Change from Baseline to 6 Months in Worst Fracture-Site Pain [ Time Frame: Baseline, 6 Months ] [ Designated as safety issue: No ]
  • Mean Change from Baseline to 6 Months in Gait Speed [ Time Frame: Baseline, 6 Months ] [ Designated as safety issue: No ]
  • Time to Revision Surgery [ Time Frame: Baseline to 12 Months ] [ Designated as safety issue: No ]
  • Mean Change from Baseline to 6 Months on Short Form-12 (SF-12) Physical and Mental Component Summary Scores [ Time Frame: Baseline, 6 Months ] [ Designated as safety issue: No ]
  • Mean Change from Baseline to 6 Months on Western Ontario McMaster Osteoarthritis Index (WOMAC) [ Time Frame: Baseline, 6 Months ] [ Designated as safety issue: No ]
  • Mean Change from Baseline to 6 Months on European Quality of Life Questionnaire (EQ-5D) [ Time Frame: Baseline, 6 Months ] [ Designated as safety issue: No ]
  • Percentage of participants with radiographic evidence of healing [ Time Frame: Baseline to 24 months ] [ Designated as safety issue: No ]
  • Percentage of participants with no revision surgery [ Time Frame: Baseline to 24 months ] [ Designated as safety issue: No ]
  • Percentage of participants with functional evidence of healing [ Time Frame: Baseline to 24 months ] [ Designated as safety issue: No ]
  • Percentage of participants with pain control [ Time Frame: Baseline to 24 months ] [ Designated as safety issue: No ]
  • Percentage of participants able to ambulate [ Time Frame: Baseline to 24 months ] [ Designated as safety issue: No ]
  • Percentage of participants without severe fracture-site pain [ Time Frame: Baseline to 24 months ] [ Designated as safety issue: No ]
  • Percentage of participants who regain their prefracture ambulatory status [ Time Frame: Baseline to 24 months ] [ Designated as safety issue: No ]
  • Mean change in worst fracture-site pain [ Time Frame: Baseline, 6 months ] [ Designated as safety issue: No ]
  • Mean change in ambulation [ Time Frame: Baseline, 6 months ] [ Designated as safety issue: No ]
  • Time to revision surgery [ Time Frame: Baseline to 24 months ] [ Designated as safety issue: No ]
  • Mean change on Short Form-12 (SF-12) physical and mental component summary scores [ Time Frame: Baseline, 6 months ] [ Designated as safety issue: No ]
  • Mean change on Western Ontario McMaster Osteoarthritis Index (WOMAC) [ Time Frame: Baseline, 6 months ] [ Designated as safety issue: No ]
  • Mean change on European Quality of Life Questionnaire (EQ-5D) [ Time Frame: Baseline, 6 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Effect of Teriparatide on Hip Fracture Healing
Effect of Teriparatide on Femoral Neck Fracture Healing

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).

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 microgram (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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Femur Neck Fracture
  • Drug: Teriparatide
    Administered by SC injection
    Other Names:
    • Forteo
    • Forsteo
    • LY333334
  • Drug: Placebo
    Administered by SC injection
  • Dietary Supplement: Calcium supplementation
    Administered orally
  • Dietary Supplement: Vitamin D supplementation
    Administered orally
  • Placebo Comparator: Placebo
    Administered once daily by subcutaneous (SC) injection for 6 months
    Interventions:
    • Drug: Placebo
    • Dietary Supplement: Calcium supplementation
    • Dietary Supplement: Vitamin D supplementation
  • Experimental: Teriparatide
    20 microgram (µg) administered once daily by SC injection for 6 months
    Interventions:
    • Drug: Teriparatide
    • Dietary Supplement: Calcium supplementation
    • Dietary Supplement: Vitamin D supplementation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
122
December 2013
December 2013   (final data collection date for primary outcome measure)

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
Both
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Canada,   Denmark,   Estonia,   Finland,   Hong Kong,   India,   Israel,   Japan,   Korea, Republic of,   Latvia,   Lithuania,   New Zealand,   Norway,   Puerto Rico,   Spain,   Sweden,   Taiwan
 
NCT01473589
13467, B3D-MC-GHDN
Yes
Eli Lilly and Company
Eli Lilly and Company
Not Provided
Study Director: 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
Eli Lilly and Company
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP