Improvement of the functional recovery of patients with a hipfracture and the prevention of re-surgery.
ID
Source
Brief title
Condition
- Fractures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
men and postmenopausal women >=50 years of age with successful fracture healing
12 months after a hip fracture.
Secondary outcome
Patient Questionnaires outcome
Background summary
Currently, hip fractures occur in approximately 300,000 patients/year in the
United States (US) and 600,000 patients/year in Europe. A fair number of all
hip fractures involve the femoral neck. There is an increasing rise in the hip
fracture rate with increasing age and, in the elderly, most hip fractures occur
after low-trauma injury such as a fall from standing height or less.
During hip-fracture recovery, most patients have pain at the fracture site,
decreased mobility, and reduced ability to perform activities of daily living.
The loss of mobility and function can be prolonged with up to 50% of patients
failing to regain their prehip fracture functional level.
Study objective
Improvement of the functional recovery of patients with a hipfracture and the
prevention of re-surgery.
Study design
Second Study of the Effect of Teriparatide on Femoral Neck Fracture Healing
Intervention
teriparatide 20 microgram per day via subcutaneous injection versus placebo
Study burden and risks
4 questionaires need to be filled out several times, a walking test needs to be
done several times using utilities such as a cane or walker; which is decribed
in detail in the patient information.
x-ray burden, venapuntions, subcutane injections
Grootslag 1 - 5
Houten 3991 RA
NL
Grootslag 1 - 5
Houten 3991 RA
NL
Listed location countries
Age
Inclusion criteria
Community dwelling men and postmenopausal women aged >=50 years who were ambulatory before sustaining a low-trauma, unilateral femoral neck fracture (displaced or non-displaced) ;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 a part of this protocol);Have given written informed consent (patient 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 and any secondary causes of osteoporosis ;Abnormally elevated values of serum calcium at baseline ;Abnormally elevated values of serum intact parathyroid hormone (PTH) (1-84) at baseline ;Severe vitamin D deficiency at baseline defined as 25-hydroxy-vitamin D levels <9.2 ng/mL;Active liver disease or jaundice;Significantly impaired renal function at baseline ;Abnormal thyroid function not corrected by therapy;History of a malignant neoplasm in the 5 years prior to Visit 1, with the exception of superficial basal cell carcinoma or squamous cell carcinoma of the skin that has been definitively treated.;History of bone marrow or solid-organ transplantation;History of symptomatic nephrolithiasis or urolithiasis in 1 year prior to visit;Prior treatment with PTH, teriparatide or other PTH analogs;Local or systemic treatment with bone morphogenic proteins or any growth factor;Previous fracture or bone surgery in the currently fractured hip;Treatment with bone grafting or osteotomies;Soft tissue infection at the operation site;Treatment with augmentation using any type of degradable cement, hydroxyapatite-coated implants or with non-invasive interventations;Associated major injuries of a lower exteremity including fractures of teh foot, ankle, tibia, fibula, knee, femur, femoral head, or pelvis; dislocations of the ankle, knee, or hip.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2011-001116-65-NL |
| CCMO | NL38359.075.11 |