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

Osteoporosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02195895
• Other study ID #: STU00083759
• Status: Completed
• Phase: Phase 2
• Start date: April 2014
• Est. completion date: August 5, 2016

Study information

• Verified date: March 2023
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: August 5, 2016
• Est. primary completion date: August 5, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bone Loss
• Osteoporosis
• Spinal Cord Injuries
• Spinal Cord Injury
• Wounds and Injuries

Intervention

Drug:
• Alendronate
Weekly oral alendronate 70 mg for 12 months

Dietary Supplement:
• Calcium
Daily oral 1000 mg Calcium
• Vitamin D
Daily oral 1000 IU

Locations

Country	Name	City	State
United States	Northwestern University Feinberg School of Medicine	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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