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

NCT ID: NCT01225055

Last Updated: 2025-12-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2016-08-31

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.

Conditions

Spinal Cord Injury; Bone Loss; Osteoporosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Teriparatide

Teriparatide alone with sham vibration

Group Type: EXPERIMENTAL

Teriparatide

Intervention Type: DRUG

20 ug daily over 12 months

Vibration

Vibration alone with placebo-teriparatide

Group Type: EXPERIMENTAL

vibration

Intervention Type: DEVICE

10 min/day for 12 months

Teriparatide and vibration

Teriparatide with vibration applied in conjuction

Group Type: EXPERIMENTAL

Teriparatide

Intervention Type: DRUG

20 ug daily over 12 months

vibration

Intervention Type: DEVICE

10 min/day for 12 months

Interventions

Teriparatide

20 ug daily over 12 months

Intervention Type: DRUG

vibration

10 min/day for 12 months

Intervention Type: DEVICE

Other Intervention Names

Forteo

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Edward Hines Jr. VA Hospital

FED

Sponsor Role: collaborator

University of Illinois at Chicago

OTHER

Sponsor Role: collaborator

Congressionally Directed Medical Research Program

UNKNOWN

Sponsor Role: collaborator

Thomas J. Schnitzer

OTHER

Sponsor Role: lead

Responsible Party

Thomas J. Schnitzer

professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Thomas J Schnizter, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

Northwestern University Feinberg School of Medicine

Chicago, Illinois, United States

Edward Hines, Jr, VA Hospital

Maywood, Illinois, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 30334093 (View on PubMed)

Other Identifiers

CDMRP-SC090010

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

STU00033380

Identifier Type: -

Identifier Source: org_study_id