Phase 2
N=25
12 Month Extension Study of the Effect of Teriparatide on Bone in People With Chronic Spinal Cord Injury (SCI)
Spinal Cord Injury · Bone Loss · Osteoporosis
Bottom Line
View on ClinicalTrials.gov: NCT02025179 ↗Enrolled (actual)
25
Serious AEs
12.5%
Results posted
Sep 2018
Primary outcome: Primary: Bone Mineral Density (BMD) of the Total Hip as Assessed by Dual-energy X-ray Absorptiometry (DXA) — 6.73; -0.34; 4.24 Percent change
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Teriparatide (Drug); Vibration (Device)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Northwestern University
- Primary completion
- Aug 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Bone Mineral Density (BMD) of the Total Hip as Assessed by Dual-energy X-ray Absorptiometry (DXA) |
6.73; -0.34; 4.24 | — |
| SECONDARY C-terminal Telopeptide |
-19.8; -14.8; -2.12 | — |
| SECONDARY Bone Mineral Density (BMD) by DXA at the Lumbar Spine |
14.4; 7.05; 8.98 | — |
| SECONDARY Bone Mineral Density (BMD) by DXA at Femoral Neck |
2.73; -0.06; 4.71 | — |
| SECONDARY Amino-terminal Propeptide of Type 1 Collagen |
102; 104; 58 | — |
| SECONDARY Bone-specific Alkaline Phosphatase |
11.5; 12.6; 10.9 | — |
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
Data sourced from ClinicalTrials.gov (NCT02025179). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.