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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alendronate | Drug | Weekly oral alendronate 70 mg for 12 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| BMD by DXA at the Lumbar Spine |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas J Schnitzer, MD, PhD | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University Feinberg School of Medicine | Chicago | Illinois | 60611 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Alendronate, Calcium, Vitamin D | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Alendronate, Calcium, Vitamin D | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | 95% Confidence Interval | Percent change | 12 months |
|
|
12 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Alendronate, Calcium, Vitamin D | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary Tract Infection (UTI) | Renal and urinary disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Thomas Schnitzer | Northwestern University | 312-503-2315 | tjs@northwestern.edu |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| D001851 | Bone Diseases, Metabolic |
| D010024 | Osteoporosis |
| D050723 | Fractures, Bone |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D014947 | Wounds and Injuries |
| ID | Term |
|---|---|
| D020196 | Trauma, Nervous System |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D019386 | Alendronate |
| D002118 | Calcium |
| D002119 | Calcium Carbonate |
| D000863 | Antacids |
| D014807 | Vitamin D |
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D004164 | Diphosphonates |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
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| Calcium | Dietary Supplement | Daily oral 1000 mg Calcium |
|
|
| Vitamin D | Dietary Supplement | Daily oral 1000 IU |
|
|
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 |
| 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 |
| 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 |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| American Spinal Injury Association (ASIA) Impairment Scale | ASIA impairment scale describes a person's functional impairment as a result of their spinal cord injury. A = Complete. No motor or sensory function in the lowest sacral spine segment (S4-5). B = Sensory Incomplete. Sensory function below the neurological level of injury (NLI) and in S4-S5, no motor function below NLI. C = Motor Incomplete. Motor function is preserved below NLI and more than half of the key muscle groups below NLI have a muscle grade < 3. D = Motor Incomplete. Motor function is preserved below NLI and at least half of the key muscle groups below NLI have a muscle grade 3. | Count of Participants | Participants |
|
| Participants |
|
|
| 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. | Posted | Mean | 95% Confidence Interval | Percent change | 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. | Posted | Mean | 95% Confidence Interval | Percent change | 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. | Posted | Mean | 95% Confidence Interval | Percent change | 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. | Posted | Mean | 95% Confidence Interval | Percent change | 12 months |
|
|
|
| 0 |
| 17 |
| 4 |
| 17 |
| 13 |
| 17 |
| Kidney stone | Renal and urinary disorders | Systematic Assessment |
|
| Sepsis | Renal and urinary disorders | Systematic Assessment | Secondary to Urinary Tract Infection |
|
| Inferior Vena Cava (IVC) filter shifted | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Spinal cord cysts | Nervous system disorders | Systematic Assessment |
|
| Pressure sore | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Abscess (perineal) | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Bacteremia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Blister | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Blood clot | Blood and lymphatic system disorders | Systematic Assessment |
|
| Cold | Infections and infestations | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
|
| Cyst | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Decrease sensation | Nervous system disorders | Systematic Assessment | Loss of sensation in left hand |
|
| Dizziness | Injury, poisoning and procedural complications | Systematic Assessment | Lightheaded during blood draw |
|
| Eye stye | Eye disorders | Systematic Assessment |
|
| Food poisoning | Gastrointestinal disorders | Systematic Assessment |
|
| Hernia | Gastrointestinal disorders | Systematic Assessment |
|
| Heterotopic Ossification | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Hypercholesterolemia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Hypertension | Blood and lymphatic system disorders | Systematic Assessment |
|
| Hypocalcemia | Endocrine disorders | Systematic Assessment |
|
| Hypokalemia | Renal and urinary disorders | Systematic Assessment |
|
| Infection (MRSA) | Infections and infestations | Systematic Assessment |
|
| Loose tooth | General disorders | Systematic Assessment |
|
| Lower extremity fracture | Injury, poisoning and procedural complications | Systematic Assessment | Distal femoral fracture |
|
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Pressure sore | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Ruptured stitches | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Soreness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Spasms | Nervous system disorders | Systematic Assessment |
|
| Benign mass removal | Surgical and medical procedures | Systematic Assessment |
|
| Tooth extraction | Surgical and medical procedures | Systematic Assessment |
|
| Urinary Tract Infection (UTI) | Renal and urinary disorders | Systematic Assessment |
|
| Worsened vision | Eye disorders | Systematic Assessment |
|
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| D013568 | Pathological Conditions, Signs and Symptoms |
| D008673 |
| Metals, Alkaline Earth |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D008670 | Metals |
| D001779 | Blood Coagulation Factors |
| D001685 | Biological Factors |
| D017610 | Calcium Compounds |
| D002254 | Carbonates |
| D002255 | Carbonic Acid |
| D017554 | Carbon Compounds, Inorganic |
| D008903 | Minerals |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D005765 | Gastrointestinal Agents |
| D045506 | Therapeutic Uses |
| D012632 | Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013261 | Sterols |
| D008563 | Membrane Lipids |
| D008055 | Lipids |