Can a daily injection and vibration rebuild bones after spinal cord injury?
NCT ID NCT01225055
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested whether a bone-building drug (teriparatide) and a vibrating platform, alone or together, could improve bone density in 60 adults with chronic spinal cord injury who had low bone mass. Participants received daily injections of teriparatide, used a vibration device for 10 minutes a day, or both, for 12 months. The main goal was to see changes in hip bone density measured by DXA scans.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Teriparatide (Forteo) and whole-body vibration
- What this could lead to
- If successful, this combination could offer a way to strengthen bones and reduce fracture risk in people with chronic spinal cord injury.
- What could go wrong
- This is a small, early-phase trial with only 60 participants. Results may not apply to everyone, and the treatment requires daily injections and a device, which may be burdensome.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
60 people
The number who actually took part.
- Start date
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Oct 2010
- Finished
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Aug 2016
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
21 years and older
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: Age \>21 years (must have closed epiphyses; PTH contraindicated if epiphyses open) * Both males and females * SCI with inability to ambulate independently * Capable of positioning to have DXA performed * Low bone mass at the total hip by DEXA (Z score \< 1.5; T score \< 2.5 or T score \<-2.0 plus preexisting fragility fracture) * Capable of reading and understanding informed consent document * Able to self-administer teriparatide or have someone in the family who can do so * No known endocrinopathies * Normal TSH levels * Normal 25-OH vitamin D levels (\> 30ng/ml) * Normal calcium levels * Normal renal function (creatinine \<2.0mg/dl) * Able to return for all follow-up visits Exclusion Criteria: Surgical or other intervention resulting in metal or anatomy precluding obtaining DXA measurements (e.g., cardiac pacemakers, ferromagnetic implants or brain aneurysm clips). * Had had an allergic reaction to Teriparatide (FORTEO) or one of its ingredients. * Have Paget's disease of the bone * Have unexplained high levels of f alkaline phosphatase in blood * Any active Gastrointestinal condition that results in malabsorption * History of presence of alcoholism or drug abuse within the 2 years prior to study screening * Other medical conditions that in the opinion of the investigator would preclude the subject from completing the study * History of malignancy. Patients having had basal cell carcinomas successfully removed will be allowed to enroll in the protocol. * History of radiation therapy * Unable to self-administer PTH or have it administered * Elevated liver function tests \>2x normal * Currently being prescribed anti-convulsants * Currently being prescribed glucocorticoids, other than inhaled glucocorticoids * Currently being prescribed any bone-active agents, including any bisphosphonate, raloxifene, hormone therapy (estrogen and estrogen/progestin), calcitonin or strontium-containing compounds. Bisphosphonate use will be allowed up the time of initiation of study medication but not during the dosing with study medication. * Previous history of PTH use * Pregnant, planning to become pregnant, or lactating
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Edward Hines, Jr, VA Hospital
Maywood, Illinois, 60153, United States
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Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60611, United States
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