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

Osteoporosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01225055
• Other study ID #: STU00033380
• Status: Completed
• Phase: Phase 2
• Start date: October 2010
• Est. completion date: August 2016

Study information

• Verified date: May 2018
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 2016
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bone Loss
• Osteoporosis
• Spinal Cord Injuries
• Spinal Cord Injury
• Wounds and Injuries

Intervention

Drug:
• Teriparatide
20 ug daily over 12 months

Device:
• vibration
10 min/day for 12 months

Locations

Country	Name	City	State
United States	Northwestern University Feinberg School of Medicine	Chicago	Illinois
United States	Edward Hines, Jr, VA Hospital	Maywood	Illinois

Sponsors (3)

Lead Sponsor	Collaborator
Thomas J. Schnitzer	Edward Hines Jr. VA Hospital, University of Illinois at Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bone Mineral Density BMD of the Total Hip as Assessed by DXA.	The mean change in BMD of the total hip after 12 month of treatment	Baseline to 12 Months
Secondary	Bone Mineral Density (BMD) by DXA at the Lumbar Spine.	The mean change in BMD at the lumbar spine from baseline after 12 month of treatment	Baseline to 12 Months
Secondary	Bone Mineral Density (BMD) by DXA at Femoral Neck	The mean change in BMD of the femoral neck after 12 month of treatment	Baseline to 12 Months
Secondary	C-terminal Telopeptide	The mean change in C-terminal telopeptide from baseline after 12 month of treatment	Baseline to 12 Months
Secondary	Bone-specific Alkaline Phosphatase	The mean change in Bone-specific alkaline phosphatase from baseline after 12 month of therapy	Baseline to 12 Months
Secondary	Amino-terminal Propeptide of Type 1 Collagen	The mean change in Amino-terminal of type 1 collagen from baseline after 12 months of treatment	Baseline to 12 Months