Primary outcomeMean· Baseline to 12 Months
Bone Mineral Density BMD of the Total Hip as Assessed by DXA.
| Group | Value (g/cm^2) | Spread |
|---|---|---|
| Teriparatide | 0.66 | 0.03 |
| Vibration | 0.63 | 0.03 |
| Teriparatide and Vibration | 0.64 | 0.03 |
Trial · Interventional
CompletedPhase 2Results postedRegistry dataEffect of Teriparatide, Vibration and the Combination on Bone Mass and Bone Architecture in Chronic Spinal Cord Injury
Overview
- Status
- Completed
- Phase
- Phase 2
- Enrollment
- 60 participants (actual)
- Sponsor
- Thomas J. Schnitzer · Other
- Design
- Randomized · Triple masking
- Countries
1 country
United States
- Start
- Oct 2010
- Primary completion
- Aug 2015
- Completion
- Aug 2016
- First posted
- 20 Oct 2010 (estimated)
- Last update posted
- 2 Dec 2025
- Conditions
- Spinal Cord Injury · Bone Loss · Osteoporosis
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
2010201220142016
- Ph 2
Effect of Teriparatide, Vibration and the Combination on Bone Mass and Bone Architecture in Chronic Spinal Cord Injury
NCT01225055Oct 2010 to Aug 2016
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- TeriparatideDrug
- vibrationDevice
Arms3
Experimental
Teriparatide
Teriparatide alone with sham vibration
Experimental
Vibration
Vibration alone with placebo-teriparatide
Experimental
Teriparatide and vibration
Teriparatide with vibration applied in conjuction
Primary outcomes1
Outcomes the sponsor listed as primary.
Bone Mineral Density BMD of the Total Hip as Assessed by DXA.
Time frame · Baseline to 12 Months
Registry description
The mean change in BMD of the total hip after 12 month of treatment
Secondary outcomes(5)
Bone Mineral Density (BMD) by DXA at the Lumbar Spine.
Time frame · Baseline to 12 Months
Registry description
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
Registry description
The mean change in BMD of the femoral neck after 12 month of treatment
C-terminal Telopeptide
Time frame · Baseline to 12 Months
Registry description
The mean change in C-terminal telopeptide from baseline after 12 month of treatment
Bone-specific Alkaline Phosphatase
Time frame · Baseline to 12 Months
Registry description
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
Registry description
The mean change in Amino-terminal of type 1 collagen from baseline after 12 months of treatment
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Secondary and other outcome results(5)
Secondary outcomeMean· Baseline to 12 Months
Bone Mineral Density (BMD) by DXA at the Lumbar Spine.
| Group | Value (g/cm^2) | Spread |
|---|---|---|
| Teriparatide | 1.04 | 0.04 |
| Vibration | 1.00 | 0.04 |
| Teriparatide and Vibration | 1.02 | 0.04 |
Secondary outcomeMean· Baseline to 12 Months
Bone Mineral Density (BMD) by DXA at Femoral Neck
| Group | Value (g/cm^2) | Spread |
|---|---|---|
| Teriparatide | 0.66 | 0.03 |
| Vibration | 0.63 | 0.03 |
| Teriparatide and Vibration | 0.62 | 0.03 |
Secondary outcomeMean· Baseline to 12 Months
C-terminal Telopeptide
| Group | Value (ng/ml) | Spread |
|---|---|---|
| Teriparatide | 0.38 | 0.07 |
| Vibration | 0.31 | 0.06 |
| Teriparatide and Vibration | 0.38 | 0.06 |
Secondary outcomeMean· Baseline to 12 Months
Bone-specific Alkaline Phosphatase
| Group | Value (ng/ml) | Spread |
|---|---|---|
| Teriparatide | 15.3 | 1.63 |
| Vibration | 13.9 | 1.53 |
| Teriparatide and Vibration | 12.4 | 1.58 |
Secondary outcomeMean· Baseline to 12 Months
Amino-terminal Propeptide of Type 1 Collagen
| Group | Value (ng/ml) | Spread |
|---|---|---|
| Teriparatide | 67.1 | 8.90 |
| Vibration | 64.7 | 8.36 |
| Teriparatide and Vibration | 67.9 | 8.61 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| TeriparatideTeriparatide alone with sham vibration Teriparatide: 20 ug daily over 12 months | 0 / 20 | 7 / 20 | 16 / 20 |
| VibrationVibration alone with placebo-teriparatide vibration: 10 min/day for 12 months | 0 / 20 | 1 / 20 | 16 / 20 |
| Teriparatide and VibrationTeriparatide with vibration applied in conjuction Teriparatide: 20 ug daily over 12 months vibration: 10 min/day for 12 months | 0 / 20 | 8 / 20 | 16 / 20 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Other registry references
References listed at the registry that are not in PepBank. They link to PubMed.
- DerivedHaider IT, Lobos SM, Simonian N, Schnitzer TJ, Edwards WB. Bone fragility after spinal cord injury: reductions in stiffness and bone mineral at the distal femur and proximal tibia as a function of time. Osteoporos Int. 2018 Dec;29(12):2703-2715. doi: 10.1007/s00198-018-4733-0. Epub 2018 Oct 17. PMID 30334093
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 21 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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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