Phase 3
N=39
Second Study of the Effect of Teriparatide on Hip Fracture Healing
Femur Neck Fracture
Bottom Line
View on ClinicalTrials.gov: NCT01473602 ↗Enrolled (actual)
39
Serious AEs
10.8%
Results posted
Nov 2014
Primary outcome: Primary: Percentage of Participants With No Revision Surgery at 12 Months After Internal Fixation of a Low-Trauma Femoral Neck Fracture — 74; 93 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Teriparatide (Drug); Placebo (Drug); Calcium supplementation (Dietary_supplement); Vitamin D supplementation (Dietary_supplement)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Eli Lilly and Company
- Primary completion
- Nov 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With No Revision Surgery at 12 Months After Internal Fixation of a Low-Trauma Femoral Neck Fracture |
74; 93 | — |
| SECONDARY Percentage of Participants With Radiographic Evidence of Healing |
55.6; 65.0 | — |
| SECONDARY Percentage of Participants With Pain Control During Ambulation |
90.0; 100.0 | — |
| SECONDARY Percentage of Participants Without Severe Fracture-Site Pain During 24 Hours Prior to Visit |
81.8; 92.9 | — |
| SECONDARY Percentage of Participants Without Severe Fracture-Site Pain During Weight Bearing |
90.9; 84.6 | — |
| SECONDARY Percentage of Participants With Functional Evidence of Healing |
76.9; 66.7 | — |
| SECONDARY Percentage of Participants Able to Ambulate |
76.9; 93.3 | — |
| SECONDARY Percentage of Participants Who Regained Their Prefracture Ambulatory Status |
47.1; 62.5 | — |
| SECONDARY Mean Change From Baseline to 6 Months in Worst Fracture-Site Pain |
-1.6; -1.3; -1.2; -1.4; -2.0; -1.4 | — |
| SECONDARY Mean Change From Baseline to 6 Months in Gait Speed |
0.168; 0.118 | — |
| SECONDARY Time to Revision Surgery |
333.5; 361 | — |
| SECONDARY Mean Change From Baseline to 6 Months on Short Form-12 (SF-12) Physical (PCS) and Mental Component Summary (MCS) Scores |
0.89; 1.78; -8.84; -10.71 | — |
| SECONDARY Mean Change From Baseline to 6 Months on Western Ontario McMaster Osteoarthritis Index (WOMAC) |
10.5; 1.1; 10.6; 13.6; 13.5; 16.9 | — |
| SECONDARY Mean Change From Baseline to 6 Months on European Quality of Life Questionnaire (EQ-5D) Overall Health Score |
13.0; 10.4 | — |
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).
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
Data sourced from ClinicalTrials.gov (NCT01473602). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.