Bone Loss, Osteoporosis, Spinal Cord Injury
Conditions
Keywords
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
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.
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.
Interventions
DRUGAlendronate
Weekly oral alendronate 70 mg for 12 months
DIETARY_SUPPLEMENTCalcium
Daily oral 1000 mg Calcium
DIETARY_SUPPLEMENTVitamin D
Daily oral 1000 IU
Sponsors
Northwestern University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 17 |
| Total | 17 |
Baseline characteristics
| Characteristic | Alendronate, Calcium, Vitamin D |
|---|---|
| Age, Continuous | 43.89 years |
| American Spinal Injury Association (ASIA) Impairment Scale ASIA A (Complete Injury) | 12 Participants |
| American Spinal Injury Association (ASIA) Impairment Scale ASIA B (Sensory Incomplete Injury) | 1 Participants |
| American Spinal Injury Association (ASIA) Impairment Scale ASIA C (Motor Incomplete Injury) | 4 Participants |
| American Spinal Injury Association (ASIA) Impairment Scale ASIA D (Motor Incomplete Injury) | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 14 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 9 Participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 17 |
| other Total, other adverse events | 13 / 17 |
| serious Total, serious adverse events | 4 / 17 |
Outcome results
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.
Time frame: 12 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Alendronate, Calcium, Vitamin D | BMD of Total Hip by DXA | 1.32 Percent change |
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.
Time frame: 12 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Alendronate, Calcium, Vitamin D | Amino-terminal Propeptide of Type 1 Collagen (P1NP) | -51.5 Percent change |
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.
Time frame: 12 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Alendronate, Calcium, Vitamin D | BMD by DXA at the Lumbar Spine | 2.54 Percent change |
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.
Time frame: 12 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Alendronate, Calcium, Vitamin D | Bone-specific Alkaline Phosphatase (BSAP) | -15.5 Percent change |
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.
Time frame: 12 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Alendronate, Calcium, Vitamin D | C-terminal Telopeptide (CTX) | -61.8 Percent change |