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Completed

NCT Number: NCT02195895

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

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.

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Key information

Conditions

Spinal Cord Injury Bone Diseases Bone Diseases, Metabolic Bone Loss Central Nervous System Diseases Fractures, Bone Metabolic Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Nutritional and Metabolic Diseases Osteoporosis Pathological Conditions, Signs and Symptoms Signs and Symptoms Spinal Cord Diseases Spinal Cord Injuries Trauma, Nervous System Wounds and Injuries

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Northwestern University Feinberg School of Medicine

Chicago, Illinois, 60611, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Alendronate

Drug

Weekly oral alendronate 70 mg for 12 months

Other names: Alendronic acid, Fosamax

Calcium

Dietary Supplement

Daily oral 1000 mg Calcium

Other names: Calcium carbonate, Antacid

Vitamin D

Dietary Supplement

Daily oral 1000 IU

Other names: Vitamin D3, Cholecalciferol

Primary outcomes

  1. BMD of Total Hip by DXA

    Time frame: 12 months

    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.

Secondary outcomes

  1. C-terminal Telopeptide (CTX)

    Time frame: 12 months

    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.

  2. BMD by DXA at the Lumbar Spine

    Time frame: 12 months

    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.

  3. Amino-terminal Propeptide of Type 1 Collagen (P1NP)

    Time frame: 12 months

    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.

  4. Bone-specific Alkaline Phosphatase (BSAP)

    Time frame: 12 months

    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.

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jul 21, 2014
Registry last updated
Mar 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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