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Can a daily injection and vibration rebuild bones after spinal cord injury?

NCT ID NCT01225055

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

Oct 2010

Finished

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

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

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.

Bone Diseases, Metabolic osteoporosis spinal cord injury

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Edward Hines, Jr, VA Hospital

    Maywood, Illinois, 60153, United States

  • Northwestern University Feinberg School of Medicine

    Chicago, Illinois, 60611, United States

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