12 Month Extension Study of the Effect of Teriparatide on Bone in People With Chronic Spinal Cord Injury (SCI)
Condition: Spinal Cord Injury; Bone Loss; Osteoporosis
MeSH terms: Osteoporosis; Spinal Cord Injuries; Wounds and Injuries
Intervention: Teriparatide; Vibration
Intervention description: Teriparatide 20 ug daily Sub-Q over 12 months; Vibration 10 min/day for 12 months
Intervention MeSH terms: Teriparatide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No
Keywords: Teriparatide; Osteoporosis; Spinal Cord Injury; Bone Diseases; Metabolic Bone Diseases; Musculoskeletal Diseases; Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Nervous System; Wounds and Injuries; Bone Density Conservation Agents; Physiological Effects of Drugs; Pharmacologic Actions; Vibration

Summary:

      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.
    

Eligibility criteria:

        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