Clinical trial NCT02195895: Effect of Alendronate on Bone in People With Chronic Spinal Cord Injury (SCI) Previously Treated With Teriparatide
Official title: 12 Month Open-Label Extension Study of the Effect of Alendronate on Bone in People With Chronic SCI Previously Treated With Teriparatide
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Spinal Cord Injury
Bone Loss
Osteoporosis
Keywords: Teriparatide
Alendronate
Alendronic Acid
Osteoporosis
Bone Fracture
Bone Loss
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
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2014-07-21
Enrollment: 17
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed description: This extension study will enroll individuals who have completed treatment in the parent protocol "Effect of Teriparatide, Vibration and the Combination on Bone Mass and Bone Architecture in Chronic Spinal Cord Injury" or in the teriparatide extension protocol. This study will allow those individuals who previously received teriparatide to be treated for a year with alendronate to maintain any bone they may have gained and to possibly increase bone mass further. Termination of teriparatide is followed by bone loss if anti-resorptive therapy is not initiated, so this approach is optimal for continued treatment of the current group of participants.

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

Primary outcomes:
measure: BMD of Total Hip by DXA
timeFrame: 12 months
Secondary outcomes:
measure: C-terminal Telopeptide (CTX)
timeFrame: 12 months
measure: BMD by DXA at the Lumbar Spine
timeFrame: 12 months
measure: Amino-terminal Propeptide of Type 1 Collagen (P1NP)
timeFrame: 12 months
measure: Bone-specific Alkaline Phosphatase (BSAP)
timeFrame: 12 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University Feinberg School of Medicine
state: Illinois
Study officials:
affiliation: Northwestern University Feinberg School of Medicine
name: Thomas J Schnitzer, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: