Trial Outcomes & Findings for Alendronate Prevents Microarchitectural Deterioration of Trabecular Bone in Early Postmenopausal Women (NCT NCT00504166)
NCT ID: NCT00504166
Last Updated: 2013-08-14
Results Overview
Trabecular number is a three-dimensional measure of the mean inter-trabecular distance; the primary micro-architectural feature measured by high-resolution CT imaging. The parameter was calculated from scans of the distal radius and distal tibia at baseline, 12, and 24 months. The percent change from baseline over these time periods was calculated as the primary outcome measure indicating the micro-architectural status of trabecular bone.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
53 participants
Primary outcome timeframe
Baseline, 24 months
Results posted on
2013-08-14
Participant Flow
Recruitment period: Feb 2006-March 2007. Recruitment ads were posted at different UCSF campuses, senior centers, churches, train stations. We also utilized mass mailing lists, newspaper ad and radio broadcasts
Participant milestones
| Measure |
Alendronate Sodium
alendronate sodium 70 mg tablet once a week for 24 months
|
Placebo
placebo to match alendronate sodium
|
|---|---|---|
|
Overall Study
STARTED
|
26
|
27
|
|
Overall Study
COMPLETED
|
20
|
13
|
|
Overall Study
NOT COMPLETED
|
6
|
14
|
Reasons for withdrawal
| Measure |
Alendronate Sodium
alendronate sodium 70 mg tablet once a week for 24 months
|
Placebo
placebo to match alendronate sodium
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
4
|
|
Overall Study
Withdrawal by Subject
|
3
|
6
|
|
Overall Study
Physician Decision
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
3
|
Baseline Characteristics
Alendronate Prevents Microarchitectural Deterioration of Trabecular Bone in Early Postmenopausal Women
Baseline characteristics by cohort
| Measure |
Alendronate Sodium
n=26 Participants
alendronate sodium 70 mg tablet once a week for 24 months
|
Placebo
n=27 Participants
placebo to match alendronate sodium
|
Total
n=53 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
26 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
55.8 years
STANDARD_DEVIATION 3.9 • n=5 Participants
|
55.4 years
STANDARD_DEVIATION 3.3 • n=7 Participants
|
55.6 years
STANDARD_DEVIATION 3.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
26 participants
n=5 Participants
|
27 participants
n=7 Participants
|
53 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 24 monthsPopulation: final statistical analysis was performed per protocol
Trabecular number is a three-dimensional measure of the mean inter-trabecular distance; the primary micro-architectural feature measured by high-resolution CT imaging. The parameter was calculated from scans of the distal radius and distal tibia at baseline, 12, and 24 months. The percent change from baseline over these time periods was calculated as the primary outcome measure indicating the micro-architectural status of trabecular bone.
Outcome measures
| Measure |
Alendronate Treatment
n=20 Participants
70 mg of alendronate once weekly and daily 2800 IU of vitamin D3 and OSCal + D (1000 mg of calcium + 400 IU of vitamin D3)
|
Placebo Treatment
n=13 Participants
daily 2800 IU of vitamin D3 and OSCal + D (1000 mg of calcium + 400 IU of vitamin D3)
|
|---|---|---|
|
Mean % Change From Baseline in Trabecular Number (Tb.N) by HR-pQCT
Distal Radius
|
2.1 Percent change
Standard Deviation 7.0
|
-0.6 Percent change
Standard Deviation 8.8
|
|
Mean % Change From Baseline in Trabecular Number (Tb.N) by HR-pQCT
Distal Tibia
|
0.9 Percent change
Standard Deviation 6.8
|
4.1 Percent change
Standard Deviation 7.5
|
Adverse Events
Alendronate Sodium
Serious events: 3 serious events
Other events: 16 other events
Deaths: 0 deaths
Placebo
Serious events: 4 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Alendronate Sodium
n=26 participants at risk
alendronate sodium 70 mg tablet once a week for 24 months
|
Placebo
n=27 participants at risk
placebo to match alendronate sodium
|
|---|---|---|
|
Endocrine disorders
significant bone mineral loss
|
0.00%
0/26
|
7.4%
2/27 • Number of events 2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
3.8%
1/26 • Number of events 1
|
0.00%
0/27
|
|
Gastrointestinal disorders
Diverticulitis
|
3.8%
1/26 • Number of events 1
|
0.00%
0/27
|
|
Psychiatric disorders
Anxiety attack
|
3.8%
1/26 • Number of events 1
|
0.00%
0/27
|
|
Gastrointestinal disorders
Difficulty swallowing
|
0.00%
0/26
|
3.7%
1/27 • Number of events 1
|
|
Injury, poisoning and procedural complications
Vitamin D overdose
|
0.00%
0/26
|
3.7%
1/27 • Number of events 1
|
Other adverse events
| Measure |
Alendronate Sodium
n=26 participants at risk
alendronate sodium 70 mg tablet once a week for 24 months
|
Placebo
n=27 participants at risk
placebo to match alendronate sodium
|
|---|---|---|
|
Blood and lymphatic system disorders
high monocyte level
|
3.8%
1/26 • Number of events 1
|
7.4%
2/27 • Number of events 2
|
|
Blood and lymphatic system disorders
Abnormal white cell count
|
19.2%
5/26 • Number of events 5
|
22.2%
6/27 • Number of events 6
|
|
Injury, poisoning and procedural complications
Broken tooth
|
3.8%
1/26 • Number of events 1
|
0.00%
0/27
|
|
Endocrine disorders
Hyperthyroidism
|
3.8%
1/26 • Number of events 1
|
0.00%
0/27
|
|
Gastrointestinal disorders
mildly unpleasant feeling in the stomach
|
0.00%
0/26
|
3.7%
1/27 • Number of events 1
|
|
Metabolism and nutrition disorders
High calcium level
|
0.00%
0/26
|
3.7%
1/27 • Number of events 1
|
|
Blood and lymphatic system disorders
Low neutrophil count
|
0.00%
0/26
|
3.7%
1/27 • Number of events 1
|
|
Metabolism and nutrition disorders
High cholesterol
|
7.7%
2/26 • Number of events 2
|
3.7%
1/27 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
osteoarthritis of the hip
|
3.8%
1/26 • Number of events 1
|
0.00%
0/27
|
|
Respiratory, thoracic and mediastinal disorders
Sinus nasal congestion
|
0.00%
0/26
|
3.7%
1/27 • Number of events 1
|
|
General disorders
sore throat
|
0.00%
0/26
|
3.7%
1/27 • Number of events 1
|
|
Renal and urinary disorders
Painful urination
|
0.00%
0/26
|
3.7%
1/27 • Number of events 1
|
|
Renal and urinary disorders
Blood-tinged urine
|
0.00%
0/26
|
3.7%
1/27 • Number of events 1
|
|
Cardiac disorders
irregular heart beat
|
0.00%
0/26
|
3.7%
1/27 • Number of events 1
|
|
Metabolism and nutrition disorders
High Phosphorus level
|
3.8%
1/26 • Number of events 1
|
0.00%
0/27
|
|
General disorders
vaginal odor
|
3.8%
1/26 • Number of events 1
|
0.00%
0/27
|
|
Gastrointestinal disorders
heartburn
|
3.8%
1/26 • Number of events 1
|
0.00%
0/27
|
|
Musculoskeletal and connective tissue disorders
Swelling, left ankle
|
3.8%
1/26 • Number of events 1
|
0.00%
0/27
|
|
Eye disorders
Conjunctivitis
|
3.8%
1/26 • Number of events 1
|
0.00%
0/27
|
|
Gastrointestinal disorders
nausea
|
3.8%
1/26 • Number of events 1
|
3.7%
1/27 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Patches of dry skin
|
0.00%
0/26
|
3.7%
1/27 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Lower respiratory tract infection
|
3.8%
1/26 • Number of events 1
|
0.00%
0/27
|
|
Gastrointestinal disorders
loose bowel movement
|
3.8%
1/26 • Number of events 1
|
0.00%
0/27
|
|
Eye disorders
Blood shot red eyes
|
3.8%
1/26 • Number of events 1
|
0.00%
0/27
|
|
General disorders
swollen tongue
|
3.8%
1/26 • Number of events 1
|
0.00%
0/27
|
|
Ear and labyrinth disorders
ear pain
|
3.8%
1/26 • Number of events 1
|
0.00%
0/27
|
|
Gastrointestinal disorders
Stomach upset
|
0.00%
0/26
|
3.7%
1/27 • Number of events 1
|
|
Infections and infestations
flu
|
0.00%
0/26
|
3.7%
1/27 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
neck pain
|
0.00%
0/26
|
3.7%
1/27 • Number of events 1
|
|
General disorders
dry mouth
|
0.00%
0/26
|
3.7%
1/27 • Number of events 1
|
|
Gastrointestinal disorders
diarrhea
|
3.8%
1/26 • Number of events 1
|
0.00%
0/27
|
|
Gastrointestinal disorders
abdominal cramping
|
3.8%
1/26 • Number of events 1
|
0.00%
0/27
|
|
Renal and urinary disorders
bladder infection
|
0.00%
0/26
|
3.7%
1/27 • Number of events 1
|
|
Infections and infestations
shingles, left forehead & scalp
|
3.8%
1/26 • Number of events 1
|
0.00%
0/27
|
|
Musculoskeletal and connective tissue disorders
cervical vertebral disk degeneration
|
0.00%
0/26
|
3.7%
1/27 • Number of events 1
|
|
Gastrointestinal disorders
Stomach flu
|
3.8%
1/26 • Number of events 1
|
0.00%
0/27
|
|
Cardiac disorders
palpitation
|
0.00%
0/26
|
3.7%
1/27 • Number of events 1
|
|
Infections and infestations
dental abscess
|
0.00%
0/26
|
3.7%
1/27 • Number of events 1
|
|
Eye disorders
Swelling, upper & lower eyelids
|
0.00%
0/26
|
3.7%
1/27 • Number of events 1
|
|
Metabolism and nutrition disorders
high uric acid level
|
0.00%
0/26
|
3.7%
1/27 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
sleep apnea
|
3.8%
1/26 • Number of events 1
|
0.00%
0/27
|
|
Blood and lymphatic system disorders
abnormal red blood cell count
|
3.8%
1/26 • Number of events 1
|
0.00%
0/27
|
|
Metabolism and nutrition disorders
high alanine aminotransferase
|
3.8%
1/26 • Number of events 1
|
0.00%
0/27
|
|
Infections and infestations
high eosinophil count
|
3.8%
1/26 • Number of events 1
|
0.00%
0/27
|
|
Infections and infestations
tooth infection #30
|
0.00%
0/26
|
3.7%
1/27 • Number of events 1
|
|
Nervous system disorders
dizziness
|
0.00%
0/26
|
3.7%
1/27 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
cough & colds
|
3.8%
1/26 • Number of events 1
|
0.00%
0/27
|
|
General disorders
Low Carbon Dioxide level
|
0.00%
0/26
|
3.7%
1/27 • Number of events 1
|
|
Renal and urinary disorders
High creatinine
|
3.8%
1/26 • Number of events 1
|
0.00%
0/27
|
Additional Information
Dr. Thomas M. Link
University of California San Francisco
Phone: 415-353-2450
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place