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

NCT02195895 | Completed Phase 2 Results

• 1 other identifier: STU00083759
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• C-terminal Telopeptide (CTX)

  12 months

• BMD by DXA at the Lumbar Spine

  12 months

• Amino-terminal Propeptide of Type 1 Collagen (P1NP)

  12 months

• Bone-specific Alkaline Phosphatase (BSAP)

  12 months

Study Arms (1)

Alendronate, Calcium, Vitamin D

EXPERIMENTAL

Drug: Weekly oral alendronate 70 mg for 12 months Supplements: 1000 mg Calcium and 1000 IU Vitamin D daily for 12 months

Drug: Alendronate; Dietary Supplement: Calcium; Dietary Supplement: Vitamin D

Interventions

Alendronate DRUG

Weekly oral alendronate 70 mg for 12 months

Also known as: Alendronic acid, Fosamax

Alendronate, Calcium, Vitamin D

Calcium DIETARY_SUPPLEMENT

Daily oral 1000 mg Calcium

Also known as: Calcium carbonate, Antacid

Alendronate, Calcium, Vitamin D

Vitamin D DIETARY_SUPPLEMENT

Daily oral 1000 IU

Also known as: Vitamin D3, Cholecalciferol

Alendronate, Calcium, Vitamin D

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University Feinberg School of Medicine

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries; Bone Diseases, Metabolic; Osteoporosis; Fractures, Bone; Bone Diseases; Musculoskeletal Diseases; Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Wounds and Injuries

Interventions

Alendronate; Calcium; Calcium Carbonate; Antacids; Vitamin D; Cholecalciferol

Condition Hierarchy (Ancestors)

Trauma, Nervous System; Metabolic Diseases; Nutritional and Metabolic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Metals, Alkaline Earth; Elements; Inorganic Chemicals; Metals; Blood Coagulation Factors; Biological Factors; Calcium Compounds; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Minerals; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Gastrointestinal Agents; Therapeutic Uses; Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Cholestenes; Cholestanes; Sterols; Membrane Lipids; Lipids

Results Point of Contact

• Title: Dr. Thomas Schnitzer
• Organization: Northwestern University

tjs@northwestern.edu

312-503-2315

Study Officials

• Thomas J Schnitzer, MD, PhD

  Northwestern University Feinberg School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 14, 2014
• First Posted: July 21, 2014
• Study Start: April 1, 2014
• Primary Completion: August 5, 2016
• Study Completion: August 5, 2016
• Last Updated: March 30, 2023
• Results First Posted: September 26, 2018

Record last verified: 2023-03

Locations

US (1)