Trial · Interventional

CompletedPhase 2Results postedRegistry data

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

NCTNCT02195895Other idSTU00083759

Open at ClinicalTrials.govAsk about this trial

This trial does not test a peptide that PepBank tracks.

Measures Teriparatide (PTH 1-34), does not give it. It appears in the eligibility rules.

Overview

Status: Completed
Phase: Phase 2
Enrollment: 17 participants (actual)
Sponsor: Northwestern University · Other
Design: Allocation not applicable · Open label (no masking)
Countries: 1 country
United States
Start: Apr 2014
Primary completion: 5 Aug 2016
Completion: 5 Aug 2016
First posted: 21 Jul 2014 (estimated)
Last update posted: 30 Mar 2023
Conditions: Spinal Cord Injury · Bone Loss · Osteoporosis

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2014201520162017

Ph 2
Effect of Alendronate on Bone in People With Chronic Spinal Cord Injury (SCI) Previously Treated With Teriparatide
NCT02195895
Apr 2014 to 5 Aug 2016

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

AlendronateDrug
CalciumDietary supplement
Vitamin DDietary supplement

Arms1

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

Primary outcomes1

Outcomes the sponsor listed as primary.

BMD of Total Hip by DXA
Time frame · 12 months
Registry description
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(4)

C-terminal Telopeptide (CTX)
Time frame · 12 months
Registry description
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.
BMD by DXA at the Lumbar Spine
Time frame · 12 months
Registry description
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.
Amino-terminal Propeptide of Type 1 Collagen (P1NP)
Time frame · 12 months
Registry description
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.
Bone-specific Alkaline Phosphatase (BSAP)
Time frame · 12 months
Registry description
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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· 12 months

BMD of Total Hip by DXA

Group	Value (Percent change)
Alendronate, Calcium, Vitamin D	1.32

Secondary and other outcome results(4)

Secondary outcomeMean· 12 months

C-terminal Telopeptide (CTX)

Group	Value (Percent change)
Alendronate, Calcium, Vitamin D	-61.8

Secondary outcomeMean· 12 months

BMD by DXA at the Lumbar Spine

Group	Value (Percent change)
Alendronate, Calcium, Vitamin D	2.54

Secondary outcomeMean· 12 months

Amino-terminal Propeptide of Type 1 Collagen (P1NP)

Group	Value (Percent change)
Alendronate, Calcium, Vitamin D	-51.5

Secondary outcomeMean· 12 months

Bone-specific Alkaline Phosphatase (BSAP)

Group	Value (Percent change)
Alendronate, Calcium, Vitamin D	-15.5

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Alendronate, Calcium, Vitamin DDrug: Weekly oral alendronate 70 mg for 12 months Supplements: Calcium and Vitamin D daily for 12 months Alendronate: Weekly oral alendronate 70 mg for 12 months Calcium: Daily Oral 1000 mg Vitamin D: Daily Oral 1000 IU	0 / 17	4 / 17	13 / 17

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 21 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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

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