Trial Outcomes & Findings for A Study of the Bioequivalence of 70 mg Alendronate and 70 mg Alendronate in Combination With 2800 IU Vitamin D (NCT NCT00806416)
NCT ID: NCT00806416
Last Updated: 2022-02-08
Results Overview
Urinary excretion of alendronate was determined over a 36-hour period following single-dose administration of a 70 mg alendronate/2800-IU vitamin D3 combination tablet or 70 mg alendronate alone tablet. Urine for each treatment period was collected at -2 to 0 hours predose, 0 to 8, 8 to 24, and 24 to 36 hours postdose.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
244 participants
Primary outcome timeframe
On Day 1 across the 36-hour urinary collection period (Periods 1 and 2).
Results posted on
2022-02-08
Participant Flow
Participants were recruited from the following clinical research organizations: Thomas Jefferson University, Division of Clinical Pharmacology, Philadelphia, PA; Clinical Pharmacology Associates, Miami, FL; and Northwest Kinetics, Tacoma, WA, between May 2003 and July 2003.
A total of 244 participants were enrolled in the study (214 participants were enrolled in Part I and 30 participants were enrolled in Part II).
Participant milestones
| Measure |
Alendronate/Vitamin D Combination Then Alendronate
70 mg alendronate/2800-IU (international unit) vitamin D3 (cholecalciferol) combination tablet; 70 mg alendronate tablet
|
Alendronate Then Alendronate/Vitamin D Combination
70 mg alendronate tablet; 70 mg alendronate/2800-IU vitamind D3 comination tablet
|
Alendronate/Vitamin D Combination Then Vitamin D
70 mg alendronate/2800-IU vitamind D3 combination tablet; 2800-IU vitamin D3 tablet
|
Vitamin D Then Alendronate/Vitamin D Combination
2800-IU vitamin D3 tablet; 70 mg alendronate/2800-IU vitamin D3 comination tablet
|
|---|---|---|---|---|
|
Period 1 - Part I
STARTED
|
107
|
107
|
0
|
0
|
|
Period 1 - Part I
COMPLETED
|
104
|
103
|
0
|
0
|
|
Period 1 - Part I
NOT COMPLETED
|
3
|
4
|
0
|
0
|
|
Period 2 - Part I
STARTED
|
104
|
103
|
0
|
0
|
|
Period 2 - Part I
COMPLETED
|
104
|
103
|
0
|
0
|
|
Period 2 - Part I
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Period 1 - Part II
STARTED
|
0
|
0
|
14
|
16
|
|
Period 1 - Part II
COMPLETED
|
0
|
0
|
14
|
14
|
|
Period 1 - Part II
NOT COMPLETED
|
0
|
0
|
0
|
2
|
|
Period 2 - Part II
STARTED
|
0
|
0
|
14
|
14
|
|
Period 2 - Part II
COMPLETED
|
0
|
0
|
14
|
14
|
|
Period 2 - Part II
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Alendronate/Vitamin D Combination Then Alendronate
70 mg alendronate/2800-IU (international unit) vitamin D3 (cholecalciferol) combination tablet; 70 mg alendronate tablet
|
Alendronate Then Alendronate/Vitamin D Combination
70 mg alendronate tablet; 70 mg alendronate/2800-IU vitamind D3 comination tablet
|
Alendronate/Vitamin D Combination Then Vitamin D
70 mg alendronate/2800-IU vitamind D3 combination tablet; 2800-IU vitamin D3 tablet
|
Vitamin D Then Alendronate/Vitamin D Combination
2800-IU vitamin D3 tablet; 70 mg alendronate/2800-IU vitamin D3 comination tablet
|
|---|---|---|---|---|
|
Period 1 - Part I
Adverse Event
|
0
|
1
|
0
|
0
|
|
Period 1 - Part I
Lost to Follow-up
|
0
|
2
|
0
|
0
|
|
Period 1 - Part I
Withdrawal by Subject
|
3
|
1
|
0
|
0
|
|
Period 1 - Part II
Withdrawal by Subject
|
0
|
0
|
0
|
2
|
Baseline Characteristics
A Study of the Bioequivalence of 70 mg Alendronate and 70 mg Alendronate in Combination With 2800 IU Vitamin D
Baseline characteristics by cohort
| Measure |
Part I
n=214 Participants
70 mg alendronate/2800-IU vitamin D3 combination tablet; 70 mg alendronate tablet
|
Part II
n=30 Participants
2800-IU vitamin D3 tablet; 70 mg alendronate/2800-IU vitamin D3 comination tablet
|
Total
n=244 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
41.6 years
n=5 Participants
|
35.2 years
n=7 Participants
|
40.8 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
119 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
133 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
95 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
111 Participants
n=5 Participants
|
|
Height
|
167.2 Centimeters
n=5 Participants
|
170.4 Centimeters
n=7 Participants
|
167.5 Centimeters
n=5 Participants
|
|
Weight
|
72.8 Kilograms
n=5 Participants
|
71.2 Kilograms
n=7 Participants
|
72.6 Kilograms
n=5 Participants
|
PRIMARY outcome
Timeframe: On Day 1 across the 36-hour urinary collection period (Periods 1 and 2).Population: Two hundred-seven (207) subjects (excluding 7 that were enrolled but did not complete both study periods) were included in the statistical analysis.
Urinary excretion of alendronate was determined over a 36-hour period following single-dose administration of a 70 mg alendronate/2800-IU vitamin D3 combination tablet or 70 mg alendronate alone tablet. Urine for each treatment period was collected at -2 to 0 hours predose, 0 to 8, 8 to 24, and 24 to 36 hours postdose.
Outcome measures
| Measure |
Alendronate/Vitamin D Combination
n=207 Participants
70 mg alendronate/2800-IU vitamin D3 combination tablet
|
Alendronate
n=207 Participants
70 mg alendronate tablet
|
|---|---|---|
|
Part 1: The Total Urinary Excretion of Alendronate With Alendronate/Vitamin D Combination Tablet Relative to Alendronate Tablet
|
197.5 micrograms (μg)
Standard Deviation 329.1
|
191.9 micrograms (μg)
Standard Deviation 522.2
|
PRIMARY outcome
Timeframe: On Day 1 across the 120-hour plasma collection period (Periods 1 and 2).Population: Twenty-eight (28) subjects (excluding 2 that were enrolled but did not complete both study periods) were included in the statistical analysis.
Serum vitamin D3 pharmacokinetic parameter AUC0-120 hr (area under the serum concentration-time curve) after treatment on Day 1was calculated following single-dose administration of a 70 mg alendronate/2800-IU vitamin D3 combination tablet or 2800-IU vitamin D3 tablet. Serum for each treatment period was collected at -24, -18, -12, -6, and 0 hours predose, and 2, 3, 5, 7, 9, 12, 16, 24, 36, 48, 72, 96, and 120 hours postdose.
Outcome measures
| Measure |
Alendronate/Vitamin D Combination
n=28 Participants
70 mg alendronate/2800-IU vitamin D3 combination tablet
|
Alendronate
n=28 Participants
70 mg alendronate tablet
|
|---|---|---|
|
Part II : The Pharmacokinetic Parameters AUC0-120 hr of Vitamin D in Combination Tablet Relative to Vitamin D Tablet
|
296.4 ng*hr/mL
Standard Deviation 375.5
|
337.9 ng*hr/mL
Standard Deviation 344.2
|
PRIMARY outcome
Timeframe: On Day 1 across the 120-hour plasma collection period (Periods 1 and 2).Serum vitamin D3 pharmacokinetic parameter Cmax (maximum concentration observed in serum) after treatmen on Day 1was calculated following single-dose administration of a 70 mg alendronate/2800-IU vitamin D3 combination tablet or 2800-IU vitamin D3 tablet. Serum for each treatment period was collected at -24, -18, -12, -6, and 0 hours predose, and 2, 3, 5, 7, 9, 12, 16, 24, 36, 48, 72, 96, and 120 hours postdose.
Outcome measures
| Measure |
Alendronate/Vitamin D Combination
n=28 Participants
70 mg alendronate/2800-IU vitamin D3 combination tablet
|
Alendronate
n=28 Participants
70 mg alendronate tablet
|
|---|---|---|
|
Part II : The Pharmacokinetic Parameters Cmax of Vitamin D in Combination Tablet Relative to Vitamin D Tablet
|
5.9 ng/mL
Standard Deviation 3.3
|
6.6 ng/mL
Standard Deviation 3.1
|
Adverse Events
Alendronate/Vitamin D Combination
Serious events: 0 serious events
Other events: 55 other events
Deaths: 0 deaths
Alendronate
Serious events: 0 serious events
Other events: 39 other events
Deaths: 0 deaths
Vitamin D
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Alendronate/Vitamin D Combination
n=240 participants at risk
70 mg alendronate/2800-IU vitamin D3 combination tablet
|
Alendronate
n=214 participants at risk
70 mg alendronate tablet
|
Vitamin D
n=30 participants at risk
2800-IU vitamin D3 tablet
|
|---|---|---|---|
|
Eye disorders
Conjunctivitis
|
0.42%
1/240
214 subjects were enrolled in Part I of the study \& 30 subjects were enrolled in Part II. All 214 subjects in the Alendronate arm \& 210 subjects from Part I and 30 subjects from Part II in the Alendronate/Vitamin D Combination are included in the analysis for safety. The 30 Vitamin D arm subjects that were enrolled in Part II are included.
|
0.00%
0/214
214 subjects were enrolled in Part I of the study \& 30 subjects were enrolled in Part II. All 214 subjects in the Alendronate arm \& 210 subjects from Part I and 30 subjects from Part II in the Alendronate/Vitamin D Combination are included in the analysis for safety. The 30 Vitamin D arm subjects that were enrolled in Part II are included.
|
3.3%
1/30
214 subjects were enrolled in Part I of the study \& 30 subjects were enrolled in Part II. All 214 subjects in the Alendronate arm \& 210 subjects from Part I and 30 subjects from Part II in the Alendronate/Vitamin D Combination are included in the analysis for safety. The 30 Vitamin D arm subjects that were enrolled in Part II are included.
|
|
Eye disorders
Keratoconjunctivitis Sicca
|
0.42%
1/240
214 subjects were enrolled in Part I of the study \& 30 subjects were enrolled in Part II. All 214 subjects in the Alendronate arm \& 210 subjects from Part I and 30 subjects from Part II in the Alendronate/Vitamin D Combination are included in the analysis for safety. The 30 Vitamin D arm subjects that were enrolled in Part II are included.
|
0.00%
0/214
214 subjects were enrolled in Part I of the study \& 30 subjects were enrolled in Part II. All 214 subjects in the Alendronate arm \& 210 subjects from Part I and 30 subjects from Part II in the Alendronate/Vitamin D Combination are included in the analysis for safety. The 30 Vitamin D arm subjects that were enrolled in Part II are included.
|
0.00%
0/30
214 subjects were enrolled in Part I of the study \& 30 subjects were enrolled in Part II. All 214 subjects in the Alendronate arm \& 210 subjects from Part I and 30 subjects from Part II in the Alendronate/Vitamin D Combination are included in the analysis for safety. The 30 Vitamin D arm subjects that were enrolled in Part II are included.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.42%
1/240
214 subjects were enrolled in Part I of the study \& 30 subjects were enrolled in Part II. All 214 subjects in the Alendronate arm \& 210 subjects from Part I and 30 subjects from Part II in the Alendronate/Vitamin D Combination are included in the analysis for safety. The 30 Vitamin D arm subjects that were enrolled in Part II are included.
|
0.47%
1/214
214 subjects were enrolled in Part I of the study \& 30 subjects were enrolled in Part II. All 214 subjects in the Alendronate arm \& 210 subjects from Part I and 30 subjects from Part II in the Alendronate/Vitamin D Combination are included in the analysis for safety. The 30 Vitamin D arm subjects that were enrolled in Part II are included.
|
0.00%
0/30
214 subjects were enrolled in Part I of the study \& 30 subjects were enrolled in Part II. All 214 subjects in the Alendronate arm \& 210 subjects from Part I and 30 subjects from Part II in the Alendronate/Vitamin D Combination are included in the analysis for safety. The 30 Vitamin D arm subjects that were enrolled in Part II are included.
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.83%
2/240
214 subjects were enrolled in Part I of the study \& 30 subjects were enrolled in Part II. All 214 subjects in the Alendronate arm \& 210 subjects from Part I and 30 subjects from Part II in the Alendronate/Vitamin D Combination are included in the analysis for safety. The 30 Vitamin D arm subjects that were enrolled in Part II are included.
|
1.4%
3/214
214 subjects were enrolled in Part I of the study \& 30 subjects were enrolled in Part II. All 214 subjects in the Alendronate arm \& 210 subjects from Part I and 30 subjects from Part II in the Alendronate/Vitamin D Combination are included in the analysis for safety. The 30 Vitamin D arm subjects that were enrolled in Part II are included.
|
0.00%
0/30
214 subjects were enrolled in Part I of the study \& 30 subjects were enrolled in Part II. All 214 subjects in the Alendronate arm \& 210 subjects from Part I and 30 subjects from Part II in the Alendronate/Vitamin D Combination are included in the analysis for safety. The 30 Vitamin D arm subjects that were enrolled in Part II are included.
|
|
Gastrointestinal disorders
Constipation
|
0.42%
1/240
214 subjects were enrolled in Part I of the study \& 30 subjects were enrolled in Part II. All 214 subjects in the Alendronate arm \& 210 subjects from Part I and 30 subjects from Part II in the Alendronate/Vitamin D Combination are included in the analysis for safety. The 30 Vitamin D arm subjects that were enrolled in Part II are included.
|
0.47%
1/214
214 subjects were enrolled in Part I of the study \& 30 subjects were enrolled in Part II. All 214 subjects in the Alendronate arm \& 210 subjects from Part I and 30 subjects from Part II in the Alendronate/Vitamin D Combination are included in the analysis for safety. The 30 Vitamin D arm subjects that were enrolled in Part II are included.
|
0.00%
0/30
214 subjects were enrolled in Part I of the study \& 30 subjects were enrolled in Part II. All 214 subjects in the Alendronate arm \& 210 subjects from Part I and 30 subjects from Part II in the Alendronate/Vitamin D Combination are included in the analysis for safety. The 30 Vitamin D arm subjects that were enrolled in Part II are included.
|
|
Gastrointestinal disorders
Diarrhoea
|
3.8%
9/240
214 subjects were enrolled in Part I of the study \& 30 subjects were enrolled in Part II. All 214 subjects in the Alendronate arm \& 210 subjects from Part I and 30 subjects from Part II in the Alendronate/Vitamin D Combination are included in the analysis for safety. The 30 Vitamin D arm subjects that were enrolled in Part II are included.
|
2.8%
6/214
214 subjects were enrolled in Part I of the study \& 30 subjects were enrolled in Part II. All 214 subjects in the Alendronate arm \& 210 subjects from Part I and 30 subjects from Part II in the Alendronate/Vitamin D Combination are included in the analysis for safety. The 30 Vitamin D arm subjects that were enrolled in Part II are included.
|
3.3%
1/30
214 subjects were enrolled in Part I of the study \& 30 subjects were enrolled in Part II. All 214 subjects in the Alendronate arm \& 210 subjects from Part I and 30 subjects from Part II in the Alendronate/Vitamin D Combination are included in the analysis for safety. The 30 Vitamin D arm subjects that were enrolled in Part II are included.
|
|
Gastrointestinal disorders
Dyspepsia
|
1.2%
3/240
214 subjects were enrolled in Part I of the study \& 30 subjects were enrolled in Part II. All 214 subjects in the Alendronate arm \& 210 subjects from Part I and 30 subjects from Part II in the Alendronate/Vitamin D Combination are included in the analysis for safety. The 30 Vitamin D arm subjects that were enrolled in Part II are included.
|
1.9%
4/214
214 subjects were enrolled in Part I of the study \& 30 subjects were enrolled in Part II. All 214 subjects in the Alendronate arm \& 210 subjects from Part I and 30 subjects from Part II in the Alendronate/Vitamin D Combination are included in the analysis for safety. The 30 Vitamin D arm subjects that were enrolled in Part II are included.
|
0.00%
0/30
214 subjects were enrolled in Part I of the study \& 30 subjects were enrolled in Part II. All 214 subjects in the Alendronate arm \& 210 subjects from Part I and 30 subjects from Part II in the Alendronate/Vitamin D Combination are included in the analysis for safety. The 30 Vitamin D arm subjects that were enrolled in Part II are included.
|
|
Gastrointestinal disorders
Flatulence
|
0.42%
1/240
214 subjects were enrolled in Part I of the study \& 30 subjects were enrolled in Part II. All 214 subjects in the Alendronate arm \& 210 subjects from Part I and 30 subjects from Part II in the Alendronate/Vitamin D Combination are included in the analysis for safety. The 30 Vitamin D arm subjects that were enrolled in Part II are included.
|
0.47%
1/214
214 subjects were enrolled in Part I of the study \& 30 subjects were enrolled in Part II. All 214 subjects in the Alendronate arm \& 210 subjects from Part I and 30 subjects from Part II in the Alendronate/Vitamin D Combination are included in the analysis for safety. The 30 Vitamin D arm subjects that were enrolled in Part II are included.
|
0.00%
0/30
214 subjects were enrolled in Part I of the study \& 30 subjects were enrolled in Part II. All 214 subjects in the Alendronate arm \& 210 subjects from Part I and 30 subjects from Part II in the Alendronate/Vitamin D Combination are included in the analysis for safety. The 30 Vitamin D arm subjects that were enrolled in Part II are included.
|
|
Gastrointestinal disorders
Intestinal Functional Disorder
|
0.42%
1/240
214 subjects were enrolled in Part I of the study \& 30 subjects were enrolled in Part II. All 214 subjects in the Alendronate arm \& 210 subjects from Part I and 30 subjects from Part II in the Alendronate/Vitamin D Combination are included in the analysis for safety. The 30 Vitamin D arm subjects that were enrolled in Part II are included.
|
0.00%
0/214
214 subjects were enrolled in Part I of the study \& 30 subjects were enrolled in Part II. All 214 subjects in the Alendronate arm \& 210 subjects from Part I and 30 subjects from Part II in the Alendronate/Vitamin D Combination are included in the analysis for safety. The 30 Vitamin D arm subjects that were enrolled in Part II are included.
|
0.00%
0/30
214 subjects were enrolled in Part I of the study \& 30 subjects were enrolled in Part II. All 214 subjects in the Alendronate arm \& 210 subjects from Part I and 30 subjects from Part II in the Alendronate/Vitamin D Combination are included in the analysis for safety. The 30 Vitamin D arm subjects that were enrolled in Part II are included.
|
|
Gastrointestinal disorders
Loose Stools
|
0.42%
1/240
214 subjects were enrolled in Part I of the study \& 30 subjects were enrolled in Part II. All 214 subjects in the Alendronate arm \& 210 subjects from Part I and 30 subjects from Part II in the Alendronate/Vitamin D Combination are included in the analysis for safety. The 30 Vitamin D arm subjects that were enrolled in Part II are included.
|
0.93%
2/214
214 subjects were enrolled in Part I of the study \& 30 subjects were enrolled in Part II. All 214 subjects in the Alendronate arm \& 210 subjects from Part I and 30 subjects from Part II in the Alendronate/Vitamin D Combination are included in the analysis for safety. The 30 Vitamin D arm subjects that were enrolled in Part II are included.
|
0.00%
0/30
214 subjects were enrolled in Part I of the study \& 30 subjects were enrolled in Part II. All 214 subjects in the Alendronate arm \& 210 subjects from Part I and 30 subjects from Part II in the Alendronate/Vitamin D Combination are included in the analysis for safety. The 30 Vitamin D arm subjects that were enrolled in Part II are included.
|
|
Gastrointestinal disorders
Nausea
|
1.7%
4/240
214 subjects were enrolled in Part I of the study \& 30 subjects were enrolled in Part II. All 214 subjects in the Alendronate arm \& 210 subjects from Part I and 30 subjects from Part II in the Alendronate/Vitamin D Combination are included in the analysis for safety. The 30 Vitamin D arm subjects that were enrolled in Part II are included.
|
1.9%
4/214
214 subjects were enrolled in Part I of the study \& 30 subjects were enrolled in Part II. All 214 subjects in the Alendronate arm \& 210 subjects from Part I and 30 subjects from Part II in the Alendronate/Vitamin D Combination are included in the analysis for safety. The 30 Vitamin D arm subjects that were enrolled in Part II are included.
|
3.3%
1/30
214 subjects were enrolled in Part I of the study \& 30 subjects were enrolled in Part II. All 214 subjects in the Alendronate arm \& 210 subjects from Part I and 30 subjects from Part II in the Alendronate/Vitamin D Combination are included in the analysis for safety. The 30 Vitamin D arm subjects that were enrolled in Part II are included.
|
|
Gastrointestinal disorders
Retching
|
0.42%
1/240
214 subjects were enrolled in Part I of the study \& 30 subjects were enrolled in Part II. All 214 subjects in the Alendronate arm \& 210 subjects from Part I and 30 subjects from Part II in the Alendronate/Vitamin D Combination are included in the analysis for safety. The 30 Vitamin D arm subjects that were enrolled in Part II are included.
|
0.00%
0/214
214 subjects were enrolled in Part I of the study \& 30 subjects were enrolled in Part II. All 214 subjects in the Alendronate arm \& 210 subjects from Part I and 30 subjects from Part II in the Alendronate/Vitamin D Combination are included in the analysis for safety. The 30 Vitamin D arm subjects that were enrolled in Part II are included.
|
0.00%
0/30
214 subjects were enrolled in Part I of the study \& 30 subjects were enrolled in Part II. All 214 subjects in the Alendronate arm \& 210 subjects from Part I and 30 subjects from Part II in the Alendronate/Vitamin D Combination are included in the analysis for safety. The 30 Vitamin D arm subjects that were enrolled in Part II are included.
|
|
Gastrointestinal disorders
Vomiting
|
2.1%
5/240
214 subjects were enrolled in Part I of the study \& 30 subjects were enrolled in Part II. All 214 subjects in the Alendronate arm \& 210 subjects from Part I and 30 subjects from Part II in the Alendronate/Vitamin D Combination are included in the analysis for safety. The 30 Vitamin D arm subjects that were enrolled in Part II are included.
|
1.4%
3/214
214 subjects were enrolled in Part I of the study \& 30 subjects were enrolled in Part II. All 214 subjects in the Alendronate arm \& 210 subjects from Part I and 30 subjects from Part II in the Alendronate/Vitamin D Combination are included in the analysis for safety. The 30 Vitamin D arm subjects that were enrolled in Part II are included.
|
0.00%
0/30
214 subjects were enrolled in Part I of the study \& 30 subjects were enrolled in Part II. All 214 subjects in the Alendronate arm \& 210 subjects from Part I and 30 subjects from Part II in the Alendronate/Vitamin D Combination are included in the analysis for safety. The 30 Vitamin D arm subjects that were enrolled in Part II are included.
|
|
General disorders
Chest Pain
|
0.83%
2/240
214 subjects were enrolled in Part I of the study \& 30 subjects were enrolled in Part II. All 214 subjects in the Alendronate arm \& 210 subjects from Part I and 30 subjects from Part II in the Alendronate/Vitamin D Combination are included in the analysis for safety. The 30 Vitamin D arm subjects that were enrolled in Part II are included.
|
0.93%
2/214
214 subjects were enrolled in Part I of the study \& 30 subjects were enrolled in Part II. All 214 subjects in the Alendronate arm \& 210 subjects from Part I and 30 subjects from Part II in the Alendronate/Vitamin D Combination are included in the analysis for safety. The 30 Vitamin D arm subjects that were enrolled in Part II are included.
|
0.00%
0/30
214 subjects were enrolled in Part I of the study \& 30 subjects were enrolled in Part II. All 214 subjects in the Alendronate arm \& 210 subjects from Part I and 30 subjects from Part II in the Alendronate/Vitamin D Combination are included in the analysis for safety. The 30 Vitamin D arm subjects that were enrolled in Part II are included.
|
|
General disorders
Pain
|
1.2%
3/240
214 subjects were enrolled in Part I of the study \& 30 subjects were enrolled in Part II. All 214 subjects in the Alendronate arm \& 210 subjects from Part I and 30 subjects from Part II in the Alendronate/Vitamin D Combination are included in the analysis for safety. The 30 Vitamin D arm subjects that were enrolled in Part II are included.
|
0.47%
1/214
214 subjects were enrolled in Part I of the study \& 30 subjects were enrolled in Part II. All 214 subjects in the Alendronate arm \& 210 subjects from Part I and 30 subjects from Part II in the Alendronate/Vitamin D Combination are included in the analysis for safety. The 30 Vitamin D arm subjects that were enrolled in Part II are included.
|
0.00%
0/30
214 subjects were enrolled in Part I of the study \& 30 subjects were enrolled in Part II. All 214 subjects in the Alendronate arm \& 210 subjects from Part I and 30 subjects from Part II in the Alendronate/Vitamin D Combination are included in the analysis for safety. The 30 Vitamin D arm subjects that were enrolled in Part II are included.
|
|
General disorders
Rigors
|
0.83%
2/240
214 subjects were enrolled in Part I of the study \& 30 subjects were enrolled in Part II. All 214 subjects in the Alendronate arm \& 210 subjects from Part I and 30 subjects from Part II in the Alendronate/Vitamin D Combination are included in the analysis for safety. The 30 Vitamin D arm subjects that were enrolled in Part II are included.
|
0.00%
0/214
214 subjects were enrolled in Part I of the study \& 30 subjects were enrolled in Part II. All 214 subjects in the Alendronate arm \& 210 subjects from Part I and 30 subjects from Part II in the Alendronate/Vitamin D Combination are included in the analysis for safety. The 30 Vitamin D arm subjects that were enrolled in Part II are included.
|
0.00%
0/30
214 subjects were enrolled in Part I of the study \& 30 subjects were enrolled in Part II. All 214 subjects in the Alendronate arm \& 210 subjects from Part I and 30 subjects from Part II in the Alendronate/Vitamin D Combination are included in the analysis for safety. The 30 Vitamin D arm subjects that were enrolled in Part II are included.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.42%
1/240
214 subjects were enrolled in Part I of the study \& 30 subjects were enrolled in Part II. All 214 subjects in the Alendronate arm \& 210 subjects from Part I and 30 subjects from Part II in the Alendronate/Vitamin D Combination are included in the analysis for safety. The 30 Vitamin D arm subjects that were enrolled in Part II are included.
|
0.00%
0/214
214 subjects were enrolled in Part I of the study \& 30 subjects were enrolled in Part II. All 214 subjects in the Alendronate arm \& 210 subjects from Part I and 30 subjects from Part II in the Alendronate/Vitamin D Combination are included in the analysis for safety. The 30 Vitamin D arm subjects that were enrolled in Part II are included.
|
0.00%
0/30
214 subjects were enrolled in Part I of the study \& 30 subjects were enrolled in Part II. All 214 subjects in the Alendronate arm \& 210 subjects from Part I and 30 subjects from Part II in the Alendronate/Vitamin D Combination are included in the analysis for safety. The 30 Vitamin D arm subjects that were enrolled in Part II are included.
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.83%
2/240
214 subjects were enrolled in Part I of the study \& 30 subjects were enrolled in Part II. All 214 subjects in the Alendronate arm \& 210 subjects from Part I and 30 subjects from Part II in the Alendronate/Vitamin D Combination are included in the analysis for safety. The 30 Vitamin D arm subjects that were enrolled in Part II are included.
|
0.00%
0/214
214 subjects were enrolled in Part I of the study \& 30 subjects were enrolled in Part II. All 214 subjects in the Alendronate arm \& 210 subjects from Part I and 30 subjects from Part II in the Alendronate/Vitamin D Combination are included in the analysis for safety. The 30 Vitamin D arm subjects that were enrolled in Part II are included.
|
0.00%
0/30
214 subjects were enrolled in Part I of the study \& 30 subjects were enrolled in Part II. All 214 subjects in the Alendronate arm \& 210 subjects from Part I and 30 subjects from Part II in the Alendronate/Vitamin D Combination are included in the analysis for safety. The 30 Vitamin D arm subjects that were enrolled in Part II are included.
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/240
214 subjects were enrolled in Part I of the study \& 30 subjects were enrolled in Part II. All 214 subjects in the Alendronate arm \& 210 subjects from Part I and 30 subjects from Part II in the Alendronate/Vitamin D Combination are included in the analysis for safety. The 30 Vitamin D arm subjects that were enrolled in Part II are included.
|
0.00%
0/214
214 subjects were enrolled in Part I of the study \& 30 subjects were enrolled in Part II. All 214 subjects in the Alendronate arm \& 210 subjects from Part I and 30 subjects from Part II in the Alendronate/Vitamin D Combination are included in the analysis for safety. The 30 Vitamin D arm subjects that were enrolled in Part II are included.
|
3.3%
1/30
214 subjects were enrolled in Part I of the study \& 30 subjects were enrolled in Part II. All 214 subjects in the Alendronate arm \& 210 subjects from Part I and 30 subjects from Part II in the Alendronate/Vitamin D Combination are included in the analysis for safety. The 30 Vitamin D arm subjects that were enrolled in Part II are included.
|
|
Injury, poisoning and procedural complications
Soft Tissue Injury
|
0.42%
1/240
214 subjects were enrolled in Part I of the study \& 30 subjects were enrolled in Part II. All 214 subjects in the Alendronate arm \& 210 subjects from Part I and 30 subjects from Part II in the Alendronate/Vitamin D Combination are included in the analysis for safety. The 30 Vitamin D arm subjects that were enrolled in Part II are included.
|
0.00%
0/214
214 subjects were enrolled in Part I of the study \& 30 subjects were enrolled in Part II. All 214 subjects in the Alendronate arm \& 210 subjects from Part I and 30 subjects from Part II in the Alendronate/Vitamin D Combination are included in the analysis for safety. The 30 Vitamin D arm subjects that were enrolled in Part II are included.
|
0.00%
0/30
214 subjects were enrolled in Part I of the study \& 30 subjects were enrolled in Part II. All 214 subjects in the Alendronate arm \& 210 subjects from Part I and 30 subjects from Part II in the Alendronate/Vitamin D Combination are included in the analysis for safety. The 30 Vitamin D arm subjects that were enrolled in Part II are included.
|
|
Investigations
Body Temperature Increased
|
0.00%
0/240
214 subjects were enrolled in Part I of the study \& 30 subjects were enrolled in Part II. All 214 subjects in the Alendronate arm \& 210 subjects from Part I and 30 subjects from Part II in the Alendronate/Vitamin D Combination are included in the analysis for safety. The 30 Vitamin D arm subjects that were enrolled in Part II are included.
|
0.47%
1/214
214 subjects were enrolled in Part I of the study \& 30 subjects were enrolled in Part II. All 214 subjects in the Alendronate arm \& 210 subjects from Part I and 30 subjects from Part II in the Alendronate/Vitamin D Combination are included in the analysis for safety. The 30 Vitamin D arm subjects that were enrolled in Part II are included.
|
0.00%
0/30
214 subjects were enrolled in Part I of the study \& 30 subjects were enrolled in Part II. All 214 subjects in the Alendronate arm \& 210 subjects from Part I and 30 subjects from Part II in the Alendronate/Vitamin D Combination are included in the analysis for safety. The 30 Vitamin D arm subjects that were enrolled in Part II are included.
|
|
Investigations
Haemoglobin Decreased
|
0.42%
1/240
214 subjects were enrolled in Part I of the study \& 30 subjects were enrolled in Part II. All 214 subjects in the Alendronate arm \& 210 subjects from Part I and 30 subjects from Part II in the Alendronate/Vitamin D Combination are included in the analysis for safety. The 30 Vitamin D arm subjects that were enrolled in Part II are included.
|
0.00%
0/214
214 subjects were enrolled in Part I of the study \& 30 subjects were enrolled in Part II. All 214 subjects in the Alendronate arm \& 210 subjects from Part I and 30 subjects from Part II in the Alendronate/Vitamin D Combination are included in the analysis for safety. The 30 Vitamin D arm subjects that were enrolled in Part II are included.
|
3.3%
1/30
214 subjects were enrolled in Part I of the study \& 30 subjects were enrolled in Part II. All 214 subjects in the Alendronate arm \& 210 subjects from Part I and 30 subjects from Part II in the Alendronate/Vitamin D Combination are included in the analysis for safety. The 30 Vitamin D arm subjects that were enrolled in Part II are included.
|
|
Investigations
White Blood Cells Urine Positive
|
0.00%
0/240
214 subjects were enrolled in Part I of the study \& 30 subjects were enrolled in Part II. All 214 subjects in the Alendronate arm \& 210 subjects from Part I and 30 subjects from Part II in the Alendronate/Vitamin D Combination are included in the analysis for safety. The 30 Vitamin D arm subjects that were enrolled in Part II are included.
|
0.00%
0/214
214 subjects were enrolled in Part I of the study \& 30 subjects were enrolled in Part II. All 214 subjects in the Alendronate arm \& 210 subjects from Part I and 30 subjects from Part II in the Alendronate/Vitamin D Combination are included in the analysis for safety. The 30 Vitamin D arm subjects that were enrolled in Part II are included.
|
3.3%
1/30
214 subjects were enrolled in Part I of the study \& 30 subjects were enrolled in Part II. All 214 subjects in the Alendronate arm \& 210 subjects from Part I and 30 subjects from Part II in the Alendronate/Vitamin D Combination are included in the analysis for safety. The 30 Vitamin D arm subjects that were enrolled in Part II are included.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.42%
1/240
214 subjects were enrolled in Part I of the study \& 30 subjects were enrolled in Part II. All 214 subjects in the Alendronate arm \& 210 subjects from Part I and 30 subjects from Part II in the Alendronate/Vitamin D Combination are included in the analysis for safety. The 30 Vitamin D arm subjects that were enrolled in Part II are included.
|
0.47%
1/214
214 subjects were enrolled in Part I of the study \& 30 subjects were enrolled in Part II. All 214 subjects in the Alendronate arm \& 210 subjects from Part I and 30 subjects from Part II in the Alendronate/Vitamin D Combination are included in the analysis for safety. The 30 Vitamin D arm subjects that were enrolled in Part II are included.
|
0.00%
0/30
214 subjects were enrolled in Part I of the study \& 30 subjects were enrolled in Part II. All 214 subjects in the Alendronate arm \& 210 subjects from Part I and 30 subjects from Part II in the Alendronate/Vitamin D Combination are included in the analysis for safety. The 30 Vitamin D arm subjects that were enrolled in Part II are included.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.42%
1/240
214 subjects were enrolled in Part I of the study \& 30 subjects were enrolled in Part II. All 214 subjects in the Alendronate arm \& 210 subjects from Part I and 30 subjects from Part II in the Alendronate/Vitamin D Combination are included in the analysis for safety. The 30 Vitamin D arm subjects that were enrolled in Part II are included.
|
0.47%
1/214
214 subjects were enrolled in Part I of the study \& 30 subjects were enrolled in Part II. All 214 subjects in the Alendronate arm \& 210 subjects from Part I and 30 subjects from Part II in the Alendronate/Vitamin D Combination are included in the analysis for safety. The 30 Vitamin D arm subjects that were enrolled in Part II are included.
|
0.00%
0/30
214 subjects were enrolled in Part I of the study \& 30 subjects were enrolled in Part II. All 214 subjects in the Alendronate arm \& 210 subjects from Part I and 30 subjects from Part II in the Alendronate/Vitamin D Combination are included in the analysis for safety. The 30 Vitamin D arm subjects that were enrolled in Part II are included.
|
|
Musculoskeletal and connective tissue disorders
Muscle Cramp
|
0.00%
0/240
214 subjects were enrolled in Part I of the study \& 30 subjects were enrolled in Part II. All 214 subjects in the Alendronate arm \& 210 subjects from Part I and 30 subjects from Part II in the Alendronate/Vitamin D Combination are included in the analysis for safety. The 30 Vitamin D arm subjects that were enrolled in Part II are included.
|
0.00%
0/214
214 subjects were enrolled in Part I of the study \& 30 subjects were enrolled in Part II. All 214 subjects in the Alendronate arm \& 210 subjects from Part I and 30 subjects from Part II in the Alendronate/Vitamin D Combination are included in the analysis for safety. The 30 Vitamin D arm subjects that were enrolled in Part II are included.
|
3.3%
1/30
214 subjects were enrolled in Part I of the study \& 30 subjects were enrolled in Part II. All 214 subjects in the Alendronate arm \& 210 subjects from Part I and 30 subjects from Part II in the Alendronate/Vitamin D Combination are included in the analysis for safety. The 30 Vitamin D arm subjects that were enrolled in Part II are included.
|
|
Nervous system disorders
Dizziness
|
1.2%
3/240
214 subjects were enrolled in Part I of the study \& 30 subjects were enrolled in Part II. All 214 subjects in the Alendronate arm \& 210 subjects from Part I and 30 subjects from Part II in the Alendronate/Vitamin D Combination are included in the analysis for safety. The 30 Vitamin D arm subjects that were enrolled in Part II are included.
|
0.47%
1/214
214 subjects were enrolled in Part I of the study \& 30 subjects were enrolled in Part II. All 214 subjects in the Alendronate arm \& 210 subjects from Part I and 30 subjects from Part II in the Alendronate/Vitamin D Combination are included in the analysis for safety. The 30 Vitamin D arm subjects that were enrolled in Part II are included.
|
0.00%
0/30
214 subjects were enrolled in Part I of the study \& 30 subjects were enrolled in Part II. All 214 subjects in the Alendronate arm \& 210 subjects from Part I and 30 subjects from Part II in the Alendronate/Vitamin D Combination are included in the analysis for safety. The 30 Vitamin D arm subjects that were enrolled in Part II are included.
|
|
Nervous system disorders
Headache
|
12.5%
30/240
214 subjects were enrolled in Part I of the study \& 30 subjects were enrolled in Part II. All 214 subjects in the Alendronate arm \& 210 subjects from Part I and 30 subjects from Part II in the Alendronate/Vitamin D Combination are included in the analysis for safety. The 30 Vitamin D arm subjects that were enrolled in Part II are included.
|
9.3%
20/214
214 subjects were enrolled in Part I of the study \& 30 subjects were enrolled in Part II. All 214 subjects in the Alendronate arm \& 210 subjects from Part I and 30 subjects from Part II in the Alendronate/Vitamin D Combination are included in the analysis for safety. The 30 Vitamin D arm subjects that were enrolled in Part II are included.
|
10.0%
3/30
214 subjects were enrolled in Part I of the study \& 30 subjects were enrolled in Part II. All 214 subjects in the Alendronate arm \& 210 subjects from Part I and 30 subjects from Part II in the Alendronate/Vitamin D Combination are included in the analysis for safety. The 30 Vitamin D arm subjects that were enrolled in Part II are included.
|
|
Nervous system disorders
Somnolence
|
0.42%
1/240
214 subjects were enrolled in Part I of the study \& 30 subjects were enrolled in Part II. All 214 subjects in the Alendronate arm \& 210 subjects from Part I and 30 subjects from Part II in the Alendronate/Vitamin D Combination are included in the analysis for safety. The 30 Vitamin D arm subjects that were enrolled in Part II are included.
|
0.47%
1/214
214 subjects were enrolled in Part I of the study \& 30 subjects were enrolled in Part II. All 214 subjects in the Alendronate arm \& 210 subjects from Part I and 30 subjects from Part II in the Alendronate/Vitamin D Combination are included in the analysis for safety. The 30 Vitamin D arm subjects that were enrolled in Part II are included.
|
0.00%
0/30
214 subjects were enrolled in Part I of the study \& 30 subjects were enrolled in Part II. All 214 subjects in the Alendronate arm \& 210 subjects from Part I and 30 subjects from Part II in the Alendronate/Vitamin D Combination are included in the analysis for safety. The 30 Vitamin D arm subjects that were enrolled in Part II are included.
|
|
Reproductive system and breast disorders
Haematospermia
|
0.42%
1/240
214 subjects were enrolled in Part I of the study \& 30 subjects were enrolled in Part II. All 214 subjects in the Alendronate arm \& 210 subjects from Part I and 30 subjects from Part II in the Alendronate/Vitamin D Combination are included in the analysis for safety. The 30 Vitamin D arm subjects that were enrolled in Part II are included.
|
0.00%
0/214
214 subjects were enrolled in Part I of the study \& 30 subjects were enrolled in Part II. All 214 subjects in the Alendronate arm \& 210 subjects from Part I and 30 subjects from Part II in the Alendronate/Vitamin D Combination are included in the analysis for safety. The 30 Vitamin D arm subjects that were enrolled in Part II are included.
|
0.00%
0/30
214 subjects were enrolled in Part I of the study \& 30 subjects were enrolled in Part II. All 214 subjects in the Alendronate arm \& 210 subjects from Part I and 30 subjects from Part II in the Alendronate/Vitamin D Combination are included in the analysis for safety. The 30 Vitamin D arm subjects that were enrolled in Part II are included.
|
|
Reproductive system and breast disorders
Menstruation Irregular
|
0.42%
1/240
214 subjects were enrolled in Part I of the study \& 30 subjects were enrolled in Part II. All 214 subjects in the Alendronate arm \& 210 subjects from Part I and 30 subjects from Part II in the Alendronate/Vitamin D Combination are included in the analysis for safety. The 30 Vitamin D arm subjects that were enrolled in Part II are included.
|
0.00%
0/214
214 subjects were enrolled in Part I of the study \& 30 subjects were enrolled in Part II. All 214 subjects in the Alendronate arm \& 210 subjects from Part I and 30 subjects from Part II in the Alendronate/Vitamin D Combination are included in the analysis for safety. The 30 Vitamin D arm subjects that were enrolled in Part II are included.
|
0.00%
0/30
214 subjects were enrolled in Part I of the study \& 30 subjects were enrolled in Part II. All 214 subjects in the Alendronate arm \& 210 subjects from Part I and 30 subjects from Part II in the Alendronate/Vitamin D Combination are included in the analysis for safety. The 30 Vitamin D arm subjects that were enrolled in Part II are included.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal Pain
|
0.42%
1/240
214 subjects were enrolled in Part I of the study \& 30 subjects were enrolled in Part II. All 214 subjects in the Alendronate arm \& 210 subjects from Part I and 30 subjects from Part II in the Alendronate/Vitamin D Combination are included in the analysis for safety. The 30 Vitamin D arm subjects that were enrolled in Part II are included.
|
0.47%
1/214
214 subjects were enrolled in Part I of the study \& 30 subjects were enrolled in Part II. All 214 subjects in the Alendronate arm \& 210 subjects from Part I and 30 subjects from Part II in the Alendronate/Vitamin D Combination are included in the analysis for safety. The 30 Vitamin D arm subjects that were enrolled in Part II are included.
|
0.00%
0/30
214 subjects were enrolled in Part I of the study \& 30 subjects were enrolled in Part II. All 214 subjects in the Alendronate arm \& 210 subjects from Part I and 30 subjects from Part II in the Alendronate/Vitamin D Combination are included in the analysis for safety. The 30 Vitamin D arm subjects that were enrolled in Part II are included.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis
|
0.42%
1/240
214 subjects were enrolled in Part I of the study \& 30 subjects were enrolled in Part II. All 214 subjects in the Alendronate arm \& 210 subjects from Part I and 30 subjects from Part II in the Alendronate/Vitamin D Combination are included in the analysis for safety. The 30 Vitamin D arm subjects that were enrolled in Part II are included.
|
0.00%
0/214
214 subjects were enrolled in Part I of the study \& 30 subjects were enrolled in Part II. All 214 subjects in the Alendronate arm \& 210 subjects from Part I and 30 subjects from Part II in the Alendronate/Vitamin D Combination are included in the analysis for safety. The 30 Vitamin D arm subjects that were enrolled in Part II are included.
|
0.00%
0/30
214 subjects were enrolled in Part I of the study \& 30 subjects were enrolled in Part II. All 214 subjects in the Alendronate arm \& 210 subjects from Part I and 30 subjects from Part II in the Alendronate/Vitamin D Combination are included in the analysis for safety. The 30 Vitamin D arm subjects that were enrolled in Part II are included.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Congestion
|
0.42%
1/240
214 subjects were enrolled in Part I of the study \& 30 subjects were enrolled in Part II. All 214 subjects in the Alendronate arm \& 210 subjects from Part I and 30 subjects from Part II in the Alendronate/Vitamin D Combination are included in the analysis for safety. The 30 Vitamin D arm subjects that were enrolled in Part II are included.
|
0.00%
0/214
214 subjects were enrolled in Part I of the study \& 30 subjects were enrolled in Part II. All 214 subjects in the Alendronate arm \& 210 subjects from Part I and 30 subjects from Part II in the Alendronate/Vitamin D Combination are included in the analysis for safety. The 30 Vitamin D arm subjects that were enrolled in Part II are included.
|
0.00%
0/30
214 subjects were enrolled in Part I of the study \& 30 subjects were enrolled in Part II. All 214 subjects in the Alendronate arm \& 210 subjects from Part I and 30 subjects from Part II in the Alendronate/Vitamin D Combination are included in the analysis for safety. The 30 Vitamin D arm subjects that were enrolled in Part II are included.
|
|
Vascular disorders
Hot Flush
|
0.00%
0/240
214 subjects were enrolled in Part I of the study \& 30 subjects were enrolled in Part II. All 214 subjects in the Alendronate arm \& 210 subjects from Part I and 30 subjects from Part II in the Alendronate/Vitamin D Combination are included in the analysis for safety. The 30 Vitamin D arm subjects that were enrolled in Part II are included.
|
0.47%
1/214
214 subjects were enrolled in Part I of the study \& 30 subjects were enrolled in Part II. All 214 subjects in the Alendronate arm \& 210 subjects from Part I and 30 subjects from Part II in the Alendronate/Vitamin D Combination are included in the analysis for safety. The 30 Vitamin D arm subjects that were enrolled in Part II are included.
|
0.00%
0/30
214 subjects were enrolled in Part I of the study \& 30 subjects were enrolled in Part II. All 214 subjects in the Alendronate arm \& 210 subjects from Part I and 30 subjects from Part II in the Alendronate/Vitamin D Combination are included in the analysis for safety. The 30 Vitamin D arm subjects that were enrolled in Part II are included.
|
Additional Information
Executive Vice President, Clinical and Quantitative Sciences
Merck Sharp & Dohme Corp
Phone: 1-800-672-6372
Results disclosure agreements
- Principal investigator is a sponsor employee Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER