Clinical trial NCT01225055: Effect of Teriparatide, Vibration and the Combination on Bone Mass and Bone Architecture in Chronic Spinal Cord Injury
Official title: Effect of Teriparatide, Vibration and the Combination on Bone Mass and Bone Architecture in Chronic Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Spinal Cord Injury
Bone Loss
Osteoporosis
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: Edward Hines Jr. VA Hospital
name: University of Illinois at Chicago
First posted: 2010-10-20
Enrollment: 60
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Bone Mineral Density BMD of the Total Hip as Assessed by DXA.
timeFrame: Baseline to 12 Months
Secondary outcomes:
measure: Bone Mineral Density (BMD) by DXA at the Lumbar Spine.
timeFrame: Baseline to 12 Months
measure: Bone Mineral Density (BMD) by DXA at Femoral Neck
timeFrame: Baseline to 12 Months
measure: C-terminal Telopeptide
timeFrame: Baseline to 12 Months
measure: Bone-specific Alkaline Phosphatase
timeFrame: Baseline to 12 Months
measure: Amino-terminal Propeptide of Type 1 Collagen
timeFrame: Baseline to 12 Months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University Feinberg School of Medicine
state: Illinois
city: Maywood
country: United States
facility: Edward Hines, Jr, VA Hospital
state: Illinois
Study officials:
affiliation: Northwestern University
name: Thomas J Schnizter, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Haider 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.