Phase 2
Completed N=17
Effect of Alendronate on Bone in People With Chronic Spinal Cord Injury (SCI) Previously Treated With Teriparatide
Source: ClinicalTrials.gov NCT02195895 ↗Enrolled (actual)
17
Serious AEs
23.5%
Results posted
Sep 2018
Primary outcomePrimary: BMD of Total Hip by DXA — 1.32 Percent change
Summary
The purpose of this study is to determine if a year of alendronate treatment will maintain or increase bone mass density (BMD) compared to baseline BMD values in people with chronic spinal cord injury (SCI).
This study will also investigate 1) if alendronate therapy will increase bone strength in people with chronic SCI, 2) the number of participants with adverse events from alendronate, and 3) the effects of alendronate on serum markers of bone metabolism.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY BMD of Total Hip by DXA |
1.32 | — |
| SECONDARY C-terminal Telopeptide (CTX) |
-61.8 | — |
| SECONDARY BMD by DXA at the Lumbar Spine |
2.54 | — |
| SECONDARY Amino-terminal Propeptide of Type 1 Collagen (P1NP) |
-51.5 | — |
| SECONDARY Bone-specific Alkaline Phosphatase (BSAP) |
-15.5 | — |
Eligibility Criteria
Inclusion Criteria
- Prior enrollment in protocol "Effect of Teriparatide, Vibration and the Combination on Bone Mass and Bone Architecture in Chronic Spinal Cord Injury", (NCT01225055).
- 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.
- Ability to understand and the willingness to sign a written informed consent.
Exclusion Criteria
- Individual with renal insufficiency (calculated creatinine clearance < 30 ml/min).
- Individuals who are not able to sit or stand upright for at least 30 minutes after taking their medication.
- Individuals with poor dental hygiene.
- Individuals with esophageal abnormalities.
- Individuals who are not able to tolerate alendronate 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 (NCT02195895). 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. Informational only — not medical advice.