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Second Study of the Effect of Teriparatide on Hip Fracture Healing

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01473602
First received: November 14, 2011
Last updated: February 28, 2013
Last verified: February 2013
History of Changes
  Purpose

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).


Condition Intervention Phase
Femur Neck Fracture
 Drug: Teriparatide
Drug: Placebo
Dietary Supplement: Calcium supplementation
Dietary Supplement: Vitamin D supplementation
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Second Study of the Effect of Teriparatide on Femoral Neck Fracture Healing

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 40
Study Start Date: August 2011
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Administered once daily by subcutaneous (SC) injection for 6 months
 Drug: Placebo
Administered by SC injection
Dietary Supplement: Calcium supplementation
Administered orally
Dietary Supplement: Vitamin D supplementation
Administered orally
Experimental: Teriparatide
20 microgram (µg) administered once daily by SC injection for 6 months
 Drug: Teriparatide
Administered by SC injection
Other Names:
  • Forteo
  • Forsteo
  • LY333334
Dietary Supplement: Calcium supplementation
Administered orally
Dietary Supplement: Vitamin D supplementation
Administered orally

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 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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01473602

  Show 80 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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
  More Information

No publications provided

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01473602     History of Changes
Other Study ID Numbers: 14125, B3D-MC-GHDQ
Study First Received: November 14, 2011
Last Updated: February 28, 2013
Health Authority: United States: Food and Drug Administration
Korea: Institutional Review Board
Austria: Ethikkommission
Belgium: Institutional Review Board
France: Institutional Ethical Committee
Greece: Ethics Committee
Hungary: Institutional Ethics Committee
Netherlands: Medical Ethics Review Committee (METC)
Poland: Ethics Committee
Romania: Ethics Committee
Switzerland: Ethikkommission
Germany: Ethics Commission

Additional relevant MeSH terms:
Femoral Neck Fractures
Fractures, Bone
Hip Fractures
Femoral Fractures
Wounds and Injuries
Leg Injuries
Vitamin D
 Teriparatide
Vitamins
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on May 16, 2013