Current partner codePEPTIDESDE
NCT01225055·Phase 2·INTERVENTIONAL

Effect of Teriparatide, Vibration and the Combination on Bone Mass and Bone Architecture in Chronic Spinal Cord Injury

Status

Completed

Phase

Phase 2

Enrollment

60

Locations

2

Results

Posted

Publications

1

Study summary

What the protocol is testing.

Spinal cord injury (SCI) results in marked acute loss of bone. This study evaluates the effect of teriparatide (PTH) and the use of vibration as a form of mechanical stimulation on bone mass.

Full detailed description

The aim of this study is to evaluate PTH with vibration in a group of individuals with chronic SCI and loss of bone mass in their lower extremities. A convenience sample of 60 subjects with SCI will be enrolled into a 12 month study assessing the effects of PTH (20 ug/day) and vibration (10 min/day) individually or in combination on BMD and bone markers. Subjects will be evaluated at 3, 6, 9, and 12 months after initiating treatment with measurement of bone density as well as bone markers of formation and resorption.

Interventions

Treatment arms and agents.

DRUG

Teriparatide

20 ug daily over 12 months

DEVICE

vibration

10 min/day for 12 months

Timeline

From registration to results.

  1. First posted

    Oct 20, 2010

  2. Study start

    Oct 2010

  3. Primary completion

    Aug 2015

  4. Study completion

    Aug 2016

  5. Results posted

    Jun 22, 2017

  6. Registry updated

    Dec 2, 2025

Outcomes

What the study measures.

Primary outcomes

Bone Mineral Density BMD of the Total Hip as Assessed by DXA.

Time frame · Baseline to 12 Months

The mean change in BMD of the total hip after 12 month of treatment

Secondary outcomes

Bone Mineral Density (BMD) by DXA at the Lumbar Spine.

Time frame · Baseline to 12 Months

The mean change in BMD at the lumbar spine from baseline after 12 month of treatment

Bone Mineral Density (BMD) by DXA at Femoral Neck

Time frame · Baseline to 12 Months

The mean change in BMD of the femoral neck after 12 month of treatment

C-terminal Telopeptide

Time frame · Baseline to 12 Months

The mean change in C-terminal telopeptide from baseline after 12 month of treatment

Bone-specific Alkaline Phosphatase

Time frame · Baseline to 12 Months

The mean change in Bone-specific alkaline phosphatase from baseline after 12 month of therapy

Amino-terminal Propeptide of Type 1 Collagen

Time frame · Baseline to 12 Months

The mean change in Amino-terminal of type 1 collagen from baseline after 12 months of treatment

Eligibility

Who can take part.

Minimum age
21 Years
Maximum age
Not reported
Sex
ALL
Healthy volunteers
No

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

Study locations

2 registered sites.

United States. Showing up to 24 locations stored in the fast local snapshot.

Northwestern University Feinberg School of Medicine

Chicago, Illinois, United States

Edward Hines, Jr, VA Hospital

Maywood, Illinois, United States

Related trials

More studies on Teriparatide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.