OsteopeniaNCT03868085
The Natural History of Injury-Related Disuse Osteopenia
An observational study of Osteopenia, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Osteopenia
- What is being tested?
- dual energy x-ray absorptiometry
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- 31 May 2017to 10 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: -Patients with one or more of the following lower extremity peri-articular fractures with restricted weight bearing for 12 weeks: (OTA types A,B,C). Injuries may be unilateral or bilateral. 1. Acetabulum fracture 2. Distal Femur fracture 3. Tibial plateau fracture 4. Pilon fracture 5. Talus fracture 6. Calcaneus fracture
Who may be able to join
- Age 18-70 at time of injury
- Previously normal community ambulator (without ambulatory aid) prior to injury
Who cannot join
- 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
Show all 11Show fewer
- Head injury on admission requiring invasive monitoring or treatment
- Inability to adhere to weight bearing restrictions
- Inability to provide consent
- Non English speaking
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
About this study
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.
Read the detailed description
It is well documented that restricted weight bearing even for relatively short periods (12 weeks) associated with the surgical treatment of peri-articular injuries of the lower extremity (ie acetabulum, distal femur, tibial plateau, pilon, talus, calcaneus) can lead to a measurable decrease in bone density in the injured limb. Furthermore, this osteopenia can persist for extended periods of time - much longer than the original period of restricted weight bearing. This relative osteopenia can delay recovery from injury, lower fracture threshold for subsequent injury and potentially delay return to active duty in the case of a wounded warrior. There exists a significant body of research in the modulation of the osteopenia associated with restricted weight bearing as it pertains to long term space flight (microgravity).
- Conditions
- Osteopenia
- Being tested
- dual energy x-ray absorptiometry
- Medical subject headings
- Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dual energy x-ray absorptiometryDiagnostic test
DXA scan
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the natural history of disuse osteopenia following restricted weight bearing from a lower extremity articular injury
Hip bone mineral density (DXA) of control and injured limb will be measured following weight bearing restrictions as part of treatment of lower limb articular injury and again following resumption of weight bearing after healing of the injury.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2019
- Study start31 May 2017
- Primary completion4 Nov 2020
- Study completion10 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteopeniaStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, J. Spence Reid, Milton S. Hershey Medical Center
- Investigators
- John S Reid, MD, Principal investigator, Milton S. Hershey Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03868085
- Sponsor's protocol ID
- 00006601
- Status last verified
- Feb 2023
- First submitted
- 30 May 2017
- Last updated
- 28 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Natural History of Injury-Related Disuse Osteopenia
- ClinicalTrials.gov ID
- NCT03868085
- Acronym / sponsor ID
- 00006601
- Conditions
- Osteopenia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Study start
- 31 May 2017 (actual)
- Primary completion
- 4 Nov 2020 (actual)
- Study completion
- 10 Dec 2020 (actual)
- First posted
- 8 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
It is well documented that restricted weight bearing even for relatively short periods (12 weeks) associated with the surgical treatment of peri-articular injuries of the lower extremity (ie acetabulum, distal femur, tibial plateau, pilon, talus, calcaneus) can lead to a measurable decrease in bone density in the injured limb. Furthermore, this osteopenia can persist for extended periods of time - much longer than the original period of restricted weight bearing. This relative osteopenia can delay recovery from injury, lower fracture threshold for subsequent injury and potentially delay return to active duty in the case of a wounded warrior. There exists a significant body of research in the modulation of the osteopenia associated with restricted weight bearing as it pertains to long term space flight (microgravity).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- -Patients with one or more of the following lower extremity peri-articular fractures with restricted weight bearing for 12 weeks: (OTA types A,B,C). Injuries may be unilateral or bilateral. 1. Acetabulum fracture 2. Distal Femur fracture 3. Tibial plateau fracture 4. Pilon fracture 5. Talus fracture 6. Calcaneus fracture
Key inclusion criteria (2 listed)
- Age 18-70 at time of injury
- Previously normal community ambulator (without ambulatory aid) prior to injury
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dual energy x-ray absorptiometryDXA scan | Diagnostic test | – |
Primary outcome
Determine the natural history of disuse osteopenia following restricted weight bearing from a lower extremity articular injury
Time frame: 36 months
Hip bone mineral density (DXA) of control and injured limb will be measured following weight bearing restrictions as part of treatment of lower limb articular injury and again following resumption of weight bearing after healing of the injury.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John S Reid, MD principal investigator
Milton S. Hershey Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteopenia, run by Milton S. Hershey Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the natural history of disuse osteopenia following restricted weight bearing from a lower extremity articular injury (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2023.