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

• Sponsor: Northwestern University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02195895
• Collaborator: (none)
• Enrollment: 17
• Location: 1
• Arm: 1
• Actual Duration (Months): 28.2
• Patients Per Site Per Month: 0.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Spinal Cord Injury; Bone Loss; Osteoporosis	Drug: Alendronate; Dietary Supplement: Calcium; Dietary Supplement: Vitamin D	Phase 2

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 17 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 12 Month Open-Label Extension Study of the Effect of Alendronate on Bone in People With Chronic SCI Previously Treated With Teriparatide
• Actual Study Start Date: Apr 1, 2014
• Actual Primary Completion Date: Aug 5, 2016
• Actual Study Completion Date: Aug 5, 2016

Arms and Interventions

Arm	Intervention/Treatment
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	Drug: Alendronate; Weekly oral alendronate 70 mg for 12 months; Other Names: Alendronic acid Fosamax ; Dietary Supplement: Calcium; Daily oral 1000 mg Calcium; Other Names: Calcium carbonate Antacid ; Dietary Supplement: Vitamin D; Daily oral 1000 IU; Other Names: Vitamin D3 Cholecalciferol

Outcome Measures

Primary Outcome Measures

1. BMD of Total Hip by DXA [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 Outcome Measures

1. C-terminal Telopeptide (CTX) [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 [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) [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) [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Northwestern University Feinberg School of Medicine	Chicago	Illinois	United States	60611

Sponsors and Collaborators

• Northwestern University

Investigators

• Principal Investigator: Thomas J Schnitzer, MD, PhD, Northwestern University Feinberg School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Thomas J. Schnitzer, Professor, Northwestern University
• ClinicalTrials.gov Identifier: NCT02195895
• Other Study ID Numbers: STU00083759
• First Posted: Jul 21, 2014
• Last Update Posted: Jan 8, 2019
• Last Verified: Dec 1, 2018

• Keywords provided by Thomas J. Schnitzer, Professor, Northwestern University: 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
• Additional relevant MeSH terms: Osteoporosis; Spinal Cord Injuries; Wounds and Injuries; Calcium, Dietary; Vitamin D; Ergocalciferols; Cholecalciferol; Alendronate; Vitamins; Calcium Carbonate; Antacids; Calcium

Study Results

Participant Flow

Arm/Group Title	Alendronate, Calcium, Vitamin D
Arm/Group Description	Drug: 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
Period Title: Overall Study
STARTED	17
COMPLETED	17
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Alendronate, Calcium, Vitamin D
Arm/Group Description	Drug: 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
Overall Participants	17
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	43.89
Sex: Female, Male (Count of Participants)
Female	4 23.5%
Male	13 76.5%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	3 17.6%
Not Hispanic or Latino	14 82.4%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	1 5.9%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	7 41.2%
White	9 52.9%
More than one race	0 0%
Unknown or Not Reported	0 0%
American Spinal Injury Association (ASIA) Impairment Scale (Count of Participants)
ASIA A (Complete Injury)	12 70.6%
ASIA B (Sensory Incomplete Injury)	1 5.9%
ASIA C (Motor Incomplete Injury)	4 23.5%
ASIA D (Motor Incomplete Injury)	0 0%

Outcome Measures

1. Primary Outcome

Title	BMD of Total Hip by DXA
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.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Alendronate, Calcium, Vitamin D
Arm/Group Description	Drug: 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
Measure Participants	17
Mean (95% Confidence Interval) [Percent change]	1.32

2. Secondary Outcome

Title	C-terminal Telopeptide (CTX)
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.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Alendronate, Calcium, Vitamin D
Arm/Group Description	Drug: 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
Measure Participants	17
Mean (95% Confidence Interval) [Percent change]	-61.8

3. Secondary Outcome

Title	BMD by DXA at the Lumbar Spine
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.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Alendronate, Calcium, Vitamin D
Arm/Group Description	Drug: 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
Measure Participants	17
Mean (95% Confidence Interval) [Percent change]	2.54

4. Secondary Outcome

Title	Amino-terminal Propeptide of Type 1 Collagen (P1NP)
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.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Alendronate, Calcium, Vitamin D
Arm/Group Description	Drug: 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
Measure Participants	17
Mean (95% Confidence Interval) [Percent change]	-51.5

5. Secondary Outcome

Title	Bone-specific Alkaline Phosphatase (BSAP)
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.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Alendronate, Calcium, Vitamin D
Arm/Group Description	Drug: 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
Measure Participants	17
Mean (95% Confidence Interval) [Percent change]	-15.5

Adverse Events

Time Frame	12 months
Arm/Group Title	Alendronate, Calcium, Vitamin D
Arm/Group Description	Drug: 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
All Cause Mortality
	Alendronate, Calcium, Vitamin D
	Affected / at Risk (%)	# Events
Total	0/17 (0%)
Serious Adverse Events
	Alendronate, Calcium, Vitamin D
	Affected / at Risk (%)	# Events
Total	4/17 (23.5%)
Injury, poisoning and procedural complications
Inferior Vena Cava (IVC) filter shifted	1/17 (5.9%)	1
Nervous system disorders
Spinal cord cysts	1/17 (5.9%)	1
Renal and urinary disorders
Urinary Tract Infection (UTI)	1/17 (5.9%)	1
Kidney stone	1/17 (5.9%)	1
Sepsis	1/17 (5.9%)	2
Skin and subcutaneous tissue disorders
Pressure sore	1/17 (5.9%)	2
Other (Not Including Serious) Adverse Events
	Alendronate, Calcium, Vitamin D
	Affected / at Risk (%)	# Events
Total	13/17 (76.5%)
Blood and lymphatic system disorders
Bacteremia	1/17 (5.9%)	1
Blood clot	1/17 (5.9%)	1
Hypercholesterolemia	1/17 (5.9%)	1
Hypertension	1/17 (5.9%)	1
Endocrine disorders
Hypocalcemia	1/17 (5.9%)	1
Eye disorders
Eye stye	1/17 (5.9%)	1
Worsened vision	1/17 (5.9%)	1
Gastrointestinal disorders
Abdominal pain	1/17 (5.9%)	1
Constipation	1/17 (5.9%)	1
Food poisoning	1/17 (5.9%)	2
Hernia	1/17 (5.9%)	1
General disorders
Loose tooth	1/17 (5.9%)	1
Infections and infestations
Cold	3/17 (17.6%)	4
Infection (MRSA)	1/17 (5.9%)	1
Injury, poisoning and procedural complications
Dizziness	1/17 (5.9%)	1
Lower extremity fracture	1/17 (5.9%)	1
Ruptured stitches	1/17 (5.9%)	1
Musculoskeletal and connective tissue disorders
Heterotopic Ossification	1/17 (5.9%)	1
Musculoskeletal Pain	3/17 (17.6%)	4
Soreness	2/17 (11.8%)	2
Nervous system disorders
Decrease sensation	1/17 (5.9%)	1
Spasms	1/17 (5.9%)	1
Renal and urinary disorders
Hypokalemia	1/17 (5.9%)	1
Urinary Tract Infection (UTI)	3/17 (17.6%)	4
Skin and subcutaneous tissue disorders
Abscess (perineal)	1/17 (5.9%)	1
Blister	1/17 (5.9%)	1
Cyst	2/17 (11.8%)	2
Pressure sore	2/17 (11.8%)	2
Surgical and medical procedures
Benign mass removal	1/17 (5.9%)	1
Tooth extraction	1/17 (5.9%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.