Trial Outcomes & Findings for Effect of Alendronate on Bone in People With Chronic Spinal Cord Injury (SCI) Previously Treated With Teriparatide (NCT NCT02195895)
NCT ID: NCT02195895
Last Updated: 2023-03-30
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
17 participants
Primary outcome timeframe
12 months
Results posted on
2023-03-30
Participant Flow
Participant milestones
| Measure |
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
|
|---|---|
|
Overall Study
STARTED
|
17
|
|
Overall Study
COMPLETED
|
17
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Alendronate on Bone in People With Chronic Spinal Cord Injury (SCI) Previously Treated With Teriparatide
Baseline characteristics by cohort
| Measure |
Alendronate, Calcium, Vitamin D
n=17 Participants
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
|
|---|---|
|
Age, Continuous
|
43.89 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
American Spinal Injury Association (ASIA) Impairment Scale
ASIA A (Complete Injury)
|
12 Participants
n=5 Participants
|
|
American Spinal Injury Association (ASIA) Impairment Scale
ASIA B (Sensory Incomplete Injury)
|
1 Participants
n=5 Participants
|
|
American Spinal Injury Association (ASIA) Impairment Scale
ASIA C (Motor Incomplete Injury)
|
4 Participants
n=5 Participants
|
|
American Spinal Injury Association (ASIA) Impairment Scale
ASIA D (Motor Incomplete Injury)
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 monthsThe 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.
Outcome measures
| Measure |
Alendronate, Calcium, Vitamin D
n=17 Participants
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
|
|---|---|
|
BMD of Total Hip by DXA
|
1.32 Percent change
Interval -1.1 to 3.75
|
SECONDARY outcome
Timeframe: 12 monthsThe 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.
Outcome measures
| Measure |
Alendronate, Calcium, Vitamin D
n=17 Participants
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
|
|---|---|
|
C-terminal Telopeptide (CTX)
|
-61.8 Percent change
Interval -99.8 to -23.7
|
SECONDARY outcome
Timeframe: 12 monthsThe 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.
Outcome measures
| Measure |
Alendronate, Calcium, Vitamin D
n=17 Participants
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
|
|---|---|
|
BMD by DXA at the Lumbar Spine
|
2.54 Percent change
Interval 0.17 to 4.9
|
SECONDARY outcome
Timeframe: 12 monthsThe 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.
Outcome measures
| Measure |
Alendronate, Calcium, Vitamin D
n=17 Participants
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
|
|---|---|
|
Amino-terminal Propeptide of Type 1 Collagen (P1NP)
|
-51.5 Percent change
Interval -93.8 to -9.27
|
SECONDARY outcome
Timeframe: 12 monthsThe 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.
Outcome measures
| Measure |
Alendronate, Calcium, Vitamin D
n=17 Participants
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
|
|---|---|
|
Bone-specific Alkaline Phosphatase (BSAP)
|
-15.5 Percent change
Interval -50.6 to 19.5
|
Adverse Events
Alendronate, Calcium, Vitamin D
Serious events: 4 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Alendronate, Calcium, Vitamin D
n=17 participants at risk
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
|
|---|---|
|
Renal and urinary disorders
Urinary Tract Infection (UTI)
|
5.9%
1/17 • Number of events 1 • 12 months
|
|
Renal and urinary disorders
Kidney stone
|
5.9%
1/17 • Number of events 1 • 12 months
|
|
Renal and urinary disorders
Sepsis
|
5.9%
1/17 • Number of events 2 • 12 months
|
|
Injury, poisoning and procedural complications
Inferior Vena Cava (IVC) filter shifted
|
5.9%
1/17 • Number of events 1 • 12 months
|
|
Nervous system disorders
Spinal cord cysts
|
5.9%
1/17 • Number of events 1 • 12 months
|
|
Skin and subcutaneous tissue disorders
Pressure sore
|
5.9%
1/17 • Number of events 2 • 12 months
|
Other adverse events
| Measure |
Alendronate, Calcium, Vitamin D
n=17 participants at risk
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
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
5.9%
1/17 • Number of events 1 • 12 months
|
|
Skin and subcutaneous tissue disorders
Abscess (perineal)
|
5.9%
1/17 • Number of events 1 • 12 months
|
|
Blood and lymphatic system disorders
Bacteremia
|
5.9%
1/17 • Number of events 1 • 12 months
|
|
Skin and subcutaneous tissue disorders
Blister
|
5.9%
1/17 • Number of events 1 • 12 months
|
|
Blood and lymphatic system disorders
Blood clot
|
5.9%
1/17 • Number of events 1 • 12 months
|
|
Infections and infestations
Cold
|
17.6%
3/17 • Number of events 4 • 12 months
|
|
Gastrointestinal disorders
Constipation
|
5.9%
1/17 • Number of events 1 • 12 months
|
|
Skin and subcutaneous tissue disorders
Cyst
|
11.8%
2/17 • Number of events 2 • 12 months
|
|
Nervous system disorders
Decrease sensation
|
5.9%
1/17 • Number of events 1 • 12 months
|
|
Injury, poisoning and procedural complications
Dizziness
|
5.9%
1/17 • Number of events 1 • 12 months
|
|
Eye disorders
Eye stye
|
5.9%
1/17 • Number of events 1 • 12 months
|
|
Gastrointestinal disorders
Food poisoning
|
5.9%
1/17 • Number of events 2 • 12 months
|
|
Gastrointestinal disorders
Hernia
|
5.9%
1/17 • Number of events 1 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Heterotopic Ossification
|
5.9%
1/17 • Number of events 1 • 12 months
|
|
Blood and lymphatic system disorders
Hypercholesterolemia
|
5.9%
1/17 • Number of events 1 • 12 months
|
|
Blood and lymphatic system disorders
Hypertension
|
5.9%
1/17 • Number of events 1 • 12 months
|
|
Endocrine disorders
Hypocalcemia
|
5.9%
1/17 • Number of events 1 • 12 months
|
|
Renal and urinary disorders
Hypokalemia
|
5.9%
1/17 • Number of events 1 • 12 months
|
|
Infections and infestations
Infection (MRSA)
|
5.9%
1/17 • Number of events 1 • 12 months
|
|
General disorders
Loose tooth
|
5.9%
1/17 • Number of events 1 • 12 months
|
|
Injury, poisoning and procedural complications
Lower extremity fracture
|
5.9%
1/17 • Number of events 1 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
17.6%
3/17 • Number of events 4 • 12 months
|
|
Skin and subcutaneous tissue disorders
Pressure sore
|
11.8%
2/17 • Number of events 2 • 12 months
|
|
Injury, poisoning and procedural complications
Ruptured stitches
|
5.9%
1/17 • Number of events 1 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Soreness
|
11.8%
2/17 • Number of events 2 • 12 months
|
|
Nervous system disorders
Spasms
|
5.9%
1/17 • Number of events 1 • 12 months
|
|
Surgical and medical procedures
Benign mass removal
|
5.9%
1/17 • Number of events 1 • 12 months
|
|
Surgical and medical procedures
Tooth extraction
|
5.9%
1/17 • Number of events 1 • 12 months
|
|
Renal and urinary disorders
Urinary Tract Infection (UTI)
|
17.6%
3/17 • Number of events 4 • 12 months
|
|
Eye disorders
Worsened vision
|
5.9%
1/17 • Number of events 1 • 12 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place