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

Phase 2

Completed

Conditions: Spinal Cord Injury
Bone Loss
Osteoporosis

Interventions: Device: vibration
Drug: Teriparatide

Registration Number: NCT01225055

Lead Sponsor: Thomas J. Schnitzer

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 60

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vibration	vibration	Vibration alone with placebo-teriparatide
Teriparatide and vibration	vibration	Teriparatide with vibration applied in conjuction
Teriparatide	Teriparatide	Teriparatide alone with sham vibration
Teriparatide and vibration	Teriparatide	Teriparatide with vibration applied in conjuction

Primary Outcome Measures

Name	Time	Method
Bone Mineral Density BMD of the Total Hip as Assessed by DXA.	Baseline to 12 Months	The mean change in BMD of the total hip after 12 month of treatment

Secondary Outcome Measures

Name	Time	Method
Bone Mineral Density (BMD) by DXA at the Lumbar Spine.	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	Baseline to 12 Months	The mean change in BMD of the femoral neck after 12 month of treatment
Amino-terminal Propeptide of Type 1 Collagen	Baseline to 12 Months	The mean change in Amino-terminal of type 1 collagen from baseline after 12 months of treatment
C-terminal Telopeptide	Baseline to 12 Months	The mean change in C-terminal telopeptide from baseline after 12 month of treatment
Bone-specific Alkaline Phosphatase	Baseline to 12 Months	The mean change in Bone-specific alkaline phosphatase from baseline after 12 month of therapy

Trial Locations

Locations (2): Northwestern University Feinberg School of Medicine
🇺🇸
Chicago, Illinois, United States
Edward Hines, Jr, VA Hospital
🇺🇸
Maywood, Illinois, United States