Effect of Alendronate on Bone in People With Chronic Spinal Cord Injury (SCI) Previously Treated With Teriparatide

Study Overview
=================
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.

Official Title
-----------------
12 Month Open-Label Extension Study of the Effect of Alendronate on Bone in People With Chronic SCI Previously Treated With Teriparatide

Conditions
-----------------
Spinal Cord Injury, Bone Loss, Osteoporosis

Intervention / Treatment
-----------------
* Drug: Alendronate
* Dietary Supplement: Calcium
* Dietary Supplement: Vitamin D


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Alendronate, Calcium, Vitamin D<br>Drug: Weekly oral alendronate 70 mg for 12 months Supplements: 1000 mg Calcium and 1000 IU Vitamin D daily for 12 months | Drug: Alendronate<br>* Weekly oral alendronate 70 mg for 12 months<br>* Other names: Fosamax;Dietary Supplement: Calcium<br>* Daily oral 1000 mg Calcium<br>* Other names: Antacid;Dietary Supplement: Vitamin D<br>* Daily oral 1000 IU<br>* Other names: Cholecalciferol;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BMD of Total Hip by DXA | The mean percent change in bone mineral density (BMD) of the hip after 12 months of treatment. BMD was evaluated by dual-energy X-ray absorptiometry (DXA). DXA scans measure bone density in different areas of the body using low-dose X-ray beams. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| C-terminal Telopeptide (CTX) | The mean percent change in C-terminal telopeptide (CTX) from baseline after 12 months of treatment. CTX is a bone marker found in blood serum and measures the rate of bone breakdown. | 12 months | 
| BMD by DXA at the Lumbar Spine | The mean percent change in bone mineral density (BMD) in the lumbar spine after 12 months of treatment. BMD was evaluated by dual-energy X-ray absorptiometry (DXA). DXA scans measure bone density in different areas of the body using low-dose X-ray beams. | 12 months | 
| Amino-terminal Propeptide of Type 1 Collagen (P1NP) | The mean percent change in amino-terminal of type 1 collagen (P1NP) from baseline after 12 months of treatment. P1NP is a bone marker found in blood serum and provides information about how fast the body is making new bone. | 12 months | 
| Bone-specific Alkaline Phosphatase (BSAP) | The mean percent change in bone-specific alkaline phosphatase (BSAP) after 12 months of treatment. BSAP is a bone marker found in blood serum and measures the rate of bone breakdown. | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
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, Teriparatide, Alendronate, Alendronic Acid