The Natural History of Injury-Related Disuse Osteopenia
Completed
Conditions studied: Osteopenia
In brief
Determine the severity and time course (natural history) of disuse osteopenia that occurs in the lower extremity(ies) and lumbar spine of patients sustaining lower extremity injuries that require the patient to maintain restricted weight bearing status (12 weeks) following the surgical fixation of the patient's injuries. The investigators hypothesize that there will be a significant decrease in the bone mineral density in the lower limbs of patients undergoing restricted weight bearing for peri-articular injuries of the lower extremity. This loss of bone mineral density is often prolonged in its duration and may lower subsequent fracture threshold and prolong the time to recovery and return to activities.
Key facts
- Study ID
- NCT03868085
- Run by
- Milton S. Hershey Medical Center
- People needed
- 51
- Starts
- 2017-05-31
- Expected to finish
- 2020-12-10
- Last updated by the study team
- 2023-02-28
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age 18-70 at time of injury
- Previously normal community ambulator (without ambulatory aid) prior to injury
You may not qualify if…
- Presence of a total or hemi hip prosthesis in the injured extremity
- Presence of lumbar fusion L1-L4
- Previous ipsilateral lower extremity trauma
- History of medical treatment for known osteoporosis (Calcium and Vitamin D supplementation alone is NOT an exclusion criteria)
- Ambulatory dysfunction prior to injury
- Inability to cooperate with DXA scanning
- Head injury on admission requiring invasive monitoring or treatment
- Inability to adhere to weight bearing restrictions
- Inability to provide consent
- Non English speaking
- Pregnancy
Where it is running
- Milton S. Hershey Medical Center — Hershey, Pennsylvania, United States
Full record on ClinicalTrials.gov
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