12 Month Extension Study of the Effect of Teriparatide on Bone in People With Chronic Spinal Cord Injury (SCI)
12 Month Extension Study of the Effect of Teriparatide on Bone in People With Chronic Spinal Cord Injury (SCI)
The purpose of this study is to determine if a second year of exposure to teriparatide in
 both subjects that received a year of teriparatide or teriparatide-placebo will result in a
 greater increase in bone mass density (BMD) compared to that seen in a single year's
 treatment.

 This study will also investigate 1) if a second year of teriparatide therapy will increase
 bone strength in people with chronic spinal cord injury (SCI) who previously received a year
 of teriparatide or teriparatide-placebo, 2) the number of participants with adverse events
 from teriparatide, and 3) the effects of teriparatide on serum markers of bone metabolism.
This extension study will only enroll individuals who have completed one year of treatment in
 the parent protocol "Effect of Teriparatide, Vibration and the Combination on Bone Mass and
 Bone Architecture in Chronic Spinal Cord Injury (NCT01225055)". This study will allow those
 individuals who received Teriparatide (20ug/day) and vibration (10 min/day) during the parent
 study to be treated for a second year and will allow those individuals who received
 teriparatide-placebo to have the opportunity to have a full year of teriparatide therapy.
 This study will determine if two years of exposure to teriparatide will result in a greater
 increase in Bone Mass Density (BMD) than that seen after a single year's treatment. Subjects
 will be evaluated at 6 and 12 months after initiating treatment with measurement of bone
 density as well as bone markers of formation and resorption.
Inclusion Criteria:

 -  Enrollment in, and completion of one year of treatment, in protocol "Effect of
 Teriparatide, Vibration and the Combination on Bone Mass and Bone Architecture in
 Chronic Spinal Cord Injury".

 -  Adherence rate for teriparatide use of ≥60%.

 -  Women of child-bearing potential and men must agree to use adequate contraception
 (hormonal or barrier method of birth control; abstinence) prior to study entry, for
 the duration of study participation, and for 90 days following completion of therapy.
 Should a woman become pregnant or suspect she is pregnant while participating in this
 study, she should inform her treating physician immediately.

 -  A female of child-bearing potential is any woman (regardless of sexual orientation,
 having undergone a tubal ligation, or remaining celibate by choice) who meets the
 following criteria:

 -  Has not undergone a hysterectomy or bilateral oophorectomy; or

 -  Has not been naturally postmenopausal for at least 12 consecutive months (i.e.,
 has had menses at any time in the preceding 12 consecutive months).

 -  Ability to understand and the willingness to sign a written informed consent.

 Exclusion Criteria:

 -  Individuals who could not tolerate teriparatide treatment.

 -  Individuals who will not be able to return for all study visits.

 -  Patients may not be receiving any other investigational agents.

 -  Other medical conditions that in the opinion of the investigator would preclude the
 subject from completing the study