Trial Outcomes & Findings for Musculoskeletal Effects of Bicarbonate (NCT NCT01475214)
NCT ID: NCT01475214
Last Updated: 2015-10-19
Results Overview
Describe and compare changes in urinary N-telopeptide (NTX) across the placebo and Potassium Bicarbonate (KHCO3) doses.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
244 participants
Primary outcome timeframe
84 days
Results posted on
2015-10-19
Participant Flow
Participant milestones
| Measure |
Potassium Bicarbonate Low Dose
potassium bicarbonate in dose of 1.0 mmol/kg per day, given in three even daily doses after meals with a full glass of water
potassium bicarbonate: potassium bicarbonate in dose of 1.0 mmol/kg per day, given in three even daily doses after meals with a full glass of water
|
Potassium Bicarbonate Higher Dose
potassium bicarbonate in dose of 1.5 mmol/kg per day, given in three even daily doses after meals with a full glass of water
potassium bicarbonate: potassium bicarbonate in dose of 1.5 mmol/kg per day, given in three even daily doses after meals with a full glass of water
|
Inactive Capsule
microcrystalline cellulose
placebo: microcrystalline cellulose
|
|---|---|---|---|
|
Overall Study
STARTED
|
84
|
79
|
81
|
|
Overall Study
COMPLETED
|
79
|
75
|
79
|
|
Overall Study
NOT COMPLETED
|
5
|
4
|
2
|
Reasons for withdrawal
| Measure |
Potassium Bicarbonate Low Dose
potassium bicarbonate in dose of 1.0 mmol/kg per day, given in three even daily doses after meals with a full glass of water
potassium bicarbonate: potassium bicarbonate in dose of 1.0 mmol/kg per day, given in three even daily doses after meals with a full glass of water
|
Potassium Bicarbonate Higher Dose
potassium bicarbonate in dose of 1.5 mmol/kg per day, given in three even daily doses after meals with a full glass of water
potassium bicarbonate: potassium bicarbonate in dose of 1.5 mmol/kg per day, given in three even daily doses after meals with a full glass of water
|
Inactive Capsule
microcrystalline cellulose
placebo: microcrystalline cellulose
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
1
|
|
Overall Study
Physician Decision
|
2
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
4
|
1
|
Baseline Characteristics
Musculoskeletal Effects of Bicarbonate
Baseline characteristics by cohort
| Measure |
Potassium Bicarbonate Low Dose
n=84 Participants
potassium bicarbonate in dose of 1.0 mmol/kg per day, given in three even daily doses after meals with a full glass of water
potassium bicarbonate: potassium bicarbonate in dose of 1.0 mmol/kg per day, given in three even daily doses after meals with a full glass of water
|
Potassium Bicarbonate Higher Dose
n=79 Participants
potassium bicarbonate in dose of 1.5 mmol/kg per day, given in three even daily doses after meals with a full glass of water
potassium bicarbonate: potassium bicarbonate in dose of 1.5 mmol/kg per day, given in three even daily doses after meals with a full glass of water
|
Inactive Placebo Capsule
n=81 Participants
microcrystalline cellulose
placebo: microcrystalline cellulose
|
Total
n=244 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
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
40 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
121 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
44 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
123 Participants
n=4 Participants
|
|
Age, Continuous
|
67.4 years
STANDARD_DEVIATION 5.5 • n=5 Participants
|
66.4 years
STANDARD_DEVIATION 5.1 • n=7 Participants
|
66.8 years
STANDARD_DEVIATION 6.1 • n=5 Participants
|
66.9 years
STANDARD_DEVIATION 5.6 • n=4 Participants
|
|
Sex: Female, Male
Female
|
41 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
118 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
43 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
126 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Caucasian, Non-hispanic
|
76 participants
n=5 Participants
|
68 participants
n=7 Participants
|
75 participants
n=5 Participants
|
219 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Caucasian, Hispanic
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
5 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
African-American
|
6 participants
n=5 Participants
|
9 participants
n=7 Participants
|
3 participants
n=5 Participants
|
18 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
2 participants
n=4 Participants
|
|
Region of Enrollment
United States
|
84 participants
n=5 Participants
|
79 participants
n=7 Participants
|
81 participants
n=5 Participants
|
244 participants
n=4 Participants
|
|
Weight
|
74.8 kg
STANDARD_DEVIATION 13.7 • n=5 Participants
|
74.2 kg
STANDARD_DEVIATION 13.0 • n=7 Participants
|
73.2 kg
STANDARD_DEVIATION 14.0 • n=5 Participants
|
74.1 kg
STANDARD_DEVIATION 13.6 • n=4 Participants
|
|
Glomerular Filtration Rate (GFR)
|
76.5 ml/min/1.73m^2
STANDARD_DEVIATION 13.2 • n=5 Participants
|
77.5 ml/min/1.73m^2
STANDARD_DEVIATION 12.8 • n=7 Participants
|
74.8 ml/min/1.73m^2
STANDARD_DEVIATION 12.9 • n=5 Participants
|
76.3 ml/min/1.73m^2
STANDARD_DEVIATION 13.0 • n=4 Participants
|
|
Serum potassium
|
4.31 meq/L
STANDARD_DEVIATION 0.29 • n=5 Participants
|
4.39 meq/L
STANDARD_DEVIATION 0.36 • n=7 Participants
|
4.30 meq/L
STANDARD_DEVIATION 0.31 • n=5 Participants
|
4.33 meq/L
STANDARD_DEVIATION 0.32 • n=4 Participants
|
|
Serum bicarbonate
|
26.1 mmol/L
STANDARD_DEVIATION 1.9 • n=5 Participants
|
25.8 mmol/L
STANDARD_DEVIATION 2.4 • n=7 Participants
|
26.1 mmol/L
STANDARD_DEVIATION 2.4 • n=5 Participants
|
26.0 mmol/L
STANDARD_DEVIATION 2.2 • n=4 Participants
|
|
Urine calcium/creatinine
|
99 mg/g
STANDARD_DEVIATION 43 • n=5 Participants
|
99 mg/g
STANDARD_DEVIATION 48 • n=7 Participants
|
114 mg/g
STANDARD_DEVIATION 69 • n=5 Participants
|
104 mg/g
STANDARD_DEVIATION 55 • n=4 Participants
|
PRIMARY outcome
Timeframe: 84 daysPopulation: Healthy men and women age 60 years and older
Describe and compare changes in urinary N-telopeptide (NTX) across the placebo and Potassium Bicarbonate (KHCO3) doses.
Outcome measures
| Measure |
Potassium Bicarbonate Low Dose
n=79 Participants
potassium bicarbonate in dose of 1.0 mmol/kg per day, given in three even daily doses after meals with a full glass of water
potassium bicarbonate: potassium bicarbonate in dose of 1.0 mmol/kg per day, given in three even daily doses after meals with a full glass of water
|
Potassium Bicarbonate Higher Dose
n=75 Participants
potassium bicarbonate in dose of 1.5 mmol/kg per day, given in three even daily doses after meals with a full glass of water
potassium bicarbonate: potassium bicarbonate in dose of 1.5 mmol/kg per day, given in three even daily doses after meals with a full glass of water
|
Inactive Placebo Capsule
n=79 Participants
microcrystalline cellulose
placebo: microcrystalline cellulose
|
|---|---|---|---|
|
The Dose of Potassium Bicarbonate Needed for Maximal Suppression of 24-hr Urinary N-telopeptide
baseline 24-hr urinary NTX
|
240 nmol/day
Standard Error 17
|
230 nmol/day
Standard Error 20
|
241 nmol/day
Standard Error 17
|
|
The Dose of Potassium Bicarbonate Needed for Maximal Suppression of 24-hr Urinary N-telopeptide
change in NTX
|
-53 nmol/day
Standard Error 11
|
-43 nmol/day
Standard Error 11
|
-14 nmol/day
Standard Error 11
|
PRIMARY outcome
Timeframe: 84 daysPopulation: healthy men and women age 60 years and older
Describe and compare changes in 24-hour urinary nitrogen in the low and high dose and KHCO3 group and in placebo.
Outcome measures
| Measure |
Potassium Bicarbonate Low Dose
n=79 Participants
potassium bicarbonate in dose of 1.0 mmol/kg per day, given in three even daily doses after meals with a full glass of water
potassium bicarbonate: potassium bicarbonate in dose of 1.0 mmol/kg per day, given in three even daily doses after meals with a full glass of water
|
Potassium Bicarbonate Higher Dose
n=75 Participants
potassium bicarbonate in dose of 1.5 mmol/kg per day, given in three even daily doses after meals with a full glass of water
potassium bicarbonate: potassium bicarbonate in dose of 1.5 mmol/kg per day, given in three even daily doses after meals with a full glass of water
|
Inactive Placebo Capsule
n=79 Participants
microcrystalline cellulose
placebo: microcrystalline cellulose
|
|---|---|---|---|
|
Co-primary Aim - to Identify the Dose of KHCO3 Needed for Maximal Suppression of 24-hr Urinary Nitrogen
change in 24-hr urine nitrogen
|
-29.4 mmol/day
Standard Error 18.6
|
-16.4 mmol/day
Standard Error 19.1
|
-21.0 mmol/day
Standard Error 18.7
|
|
Co-primary Aim - to Identify the Dose of KHCO3 Needed for Maximal Suppression of 24-hr Urinary Nitrogen
baseline 24-hr urine nitrogen
|
769 mmol/day
Standard Error 32
|
834 mmol/day
Standard Error 39
|
864 mmol/day
Standard Error 33
|
Adverse Events
Potassium Bicarbonate Low Dose
Serious events: 3 serious events
Other events: 19 other events
Deaths: 0 deaths
Potassium Bicarbonate Higher Dose
Serious events: 3 serious events
Other events: 29 other events
Deaths: 0 deaths
Inactive Capsule
Serious events: 1 serious events
Other events: 23 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Potassium Bicarbonate Low Dose
n=84 participants at risk
potassium bicarbonate in dose of 1.0 mmol/kg per day, given in three even daily doses after meals with a full glass of water
potassium bicarbonate: potassium bicarbonate in dose of 1.0 mmol/kg per day, given in three even daily doses after meals with a full glass of water
|
Potassium Bicarbonate Higher Dose
n=79 participants at risk
potassium bicarbonate in dose of 1.5 mmol/kg per day, given in three even daily doses after meals with a full glass of water
potassium bicarbonate: potassium bicarbonate in dose of 1.5 mmol/kg per day, given in three even daily doses after meals with a full glass of water
|
Inactive Capsule
n=81 participants at risk
microcrystalline cellulose
placebo: microcrystalline cellulose
|
|---|---|---|---|
|
Renal and urinary disorders
High serum potassium
|
0.00%
0/84 • 84 days
|
1.3%
1/79 • Number of events 1 • 84 days
|
0.00%
0/81 • 84 days
|
|
Musculoskeletal and connective tissue disorders
Contusions/abrasions
|
1.2%
1/84 • Number of events 1 • 84 days
|
1.3%
1/79 • Number of events 1 • 84 days
|
0.00%
0/81 • 84 days
|
|
Gastrointestinal disorders
GI upset
|
1.2%
1/84 • Number of events 1 • 84 days
|
0.00%
0/79 • 84 days
|
0.00%
0/81 • 84 days
|
|
Cardiac disorders
Abdominal aortic repair
|
0.00%
0/84 • 84 days
|
0.00%
0/79 • 84 days
|
1.2%
1/81 • Number of events 1 • 84 days
|
|
Musculoskeletal and connective tissue disorders
Fracture
|
0.00%
0/84 • 84 days
|
1.3%
1/79 • Number of events 1 • 84 days
|
0.00%
0/81 • 84 days
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
1.2%
1/84 • Number of events 1 • 84 days
|
0.00%
0/79 • 84 days
|
0.00%
0/81 • 84 days
|
Other adverse events
| Measure |
Potassium Bicarbonate Low Dose
n=84 participants at risk
potassium bicarbonate in dose of 1.0 mmol/kg per day, given in three even daily doses after meals with a full glass of water
potassium bicarbonate: potassium bicarbonate in dose of 1.0 mmol/kg per day, given in three even daily doses after meals with a full glass of water
|
Potassium Bicarbonate Higher Dose
n=79 participants at risk
potassium bicarbonate in dose of 1.5 mmol/kg per day, given in three even daily doses after meals with a full glass of water
potassium bicarbonate: potassium bicarbonate in dose of 1.5 mmol/kg per day, given in three even daily doses after meals with a full glass of water
|
Inactive Capsule
n=81 participants at risk
microcrystalline cellulose
placebo: microcrystalline cellulose
|
|---|---|---|---|
|
Renal and urinary disorders
High serum potassium
|
6.0%
5/84 • Number of events 7 • 84 days
|
10.1%
8/79 • Number of events 10 • 84 days
|
6.2%
5/81 • Number of events 9 • 84 days
|
|
Renal and urinary disorders
low GFR
|
4.8%
4/84 • Number of events 5 • 84 days
|
3.8%
3/79 • Number of events 3 • 84 days
|
3.7%
3/81 • Number of events 3 • 84 days
|
|
Gastrointestinal disorders
GI upset
|
6.0%
5/84 • Number of events 5 • 84 days
|
11.4%
9/79 • Number of events 11 • 84 days
|
7.4%
6/81 • Number of events 6 • 84 days
|
|
General disorders
Headache
|
1.2%
1/84 • Number of events 1 • 84 days
|
1.3%
1/79 • Number of events 1 • 84 days
|
2.5%
2/81 • Number of events 2 • 84 days
|
|
Cardiac disorders
Heart palpitations
|
0.00%
0/84 • 84 days
|
1.3%
1/79 • Number of events 1 • 84 days
|
1.2%
1/81 • Number of events 1 • 84 days
|
|
General disorders
Fever, fatigue
|
0.00%
0/84 • 84 days
|
0.00%
0/79 • 84 days
|
1.2%
1/81 • Number of events 1 • 84 days
|
|
General disorders
dizziness
|
1.2%
1/84 • Number of events 1 • 84 days
|
2.5%
2/79 • Number of events 2 • 84 days
|
0.00%
0/81 • 84 days
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection
|
0.00%
0/84 • 84 days
|
0.00%
0/79 • 84 days
|
1.2%
1/81 • Number of events 1 • 84 days
|
|
Musculoskeletal and connective tissue disorders
Knee/hip injury
|
1.2%
1/84 • Number of events 1 • 84 days
|
2.5%
2/79 • Number of events 2 • 84 days
|
0.00%
0/81 • 84 days
|
|
Musculoskeletal and connective tissue disorders
Sprain
|
0.00%
0/84 • 84 days
|
0.00%
0/79 • 84 days
|
3.7%
3/81 • Number of events 3 • 84 days
|
|
General disorders
Mouth irritation
|
0.00%
0/84 • 84 days
|
0.00%
0/79 • 84 days
|
1.2%
1/81 • Number of events 1 • 84 days
|
|
Gastrointestinal disorders
Constipation/diarrhea
|
1.2%
1/84 • Number of events 1 • 84 days
|
1.3%
1/79 • Number of events 1 • 84 days
|
1.2%
1/81 • Number of events 1 • 84 days
|
|
Eye disorders
Cataract
|
1.2%
1/84 • Number of events 1 • 84 days
|
0.00%
0/79 • 84 days
|
0.00%
0/81 • 84 days
|
|
Musculoskeletal and connective tissue disorders
Numbness
|
0.00%
0/84 • 84 days
|
1.3%
1/79 • Number of events 1 • 84 days
|
0.00%
0/81 • 84 days
|
|
Skin and subcutaneous tissue disorders
Skin cyst
|
0.00%
0/84 • 84 days
|
1.3%
1/79 • Number of events 1 • 84 days
|
0.00%
0/81 • 84 days
|
Additional Information
Dr. Bess Dawson-Hughes
Jean Mayer Human Nutrition Research Center on Aging at Tufts University
Phone: 617-556-3066
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place