Trial Outcomes & Findings for The Effects of Potassium Citrate on Bone Metabolism (NCT NCT00357331)

NCT ID: NCT00357331

Last Updated: 2017-06-12

Results Overview

One measure of bone turnover was urinary-NTX as a second void morning urine.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 83 participants
• Primary outcome timeframe: Baseline,1,3,6,12 months
• Results posted on: 2017-06-12

Participant Flow

Participant milestones

Measure	Potassium Citrate Potassium Citrate 20 meq twice daily potassium citrate: 20 meq by mouth in capsule form twice daily	Placebo Placebo Placebo 20 meq by mouth in capsule form twice daily
Overall Study STARTED	42	41
Overall Study COMPLETED	42	41
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Effects of Potassium Citrate on Bone Metabolism

Baseline characteristics by cohort

Measure	Placebo n=41 Participants	Potassium Citrate n=42 Participants	Total n=83 Participants Total of all reporting groups
Age, Categorical Age · <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Age · Between 18 and 65 years	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
Age, Categorical Age · >=65 years	38 Participants n=5 Participants	37 Participants n=7 Participants	75 Participants n=5 Participants
Age, Continuous	66.1 years STANDARD_DEVIATION 7.1 • n=5 Participants	65.1 years STANDARD_DEVIATION 5.9 • n=7 Participants	65.8 years STANDARD_DEVIATION 6.2 • n=5 Participants
Sex: Female, Male Female	41 Participants n=5 Participants	42 Participants n=7 Participants	83 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	41 participants n=5 Participants	42 participants n=7 Participants	83 participants n=5 Participants
BMI	23 kg/m2 STANDARD_DEVIATION 2.5 • n=5 Participants	24 kg/m2 STANDARD_DEVIATION 3.3 • n=7 Participants	23 kg/m2 STANDARD_DEVIATION 3.0 • n=5 Participants
PTH	58.8 pg/mL STANDARD_DEVIATION 25 • n=5 Participants	56.9 pg/mL STANDARD_DEVIATION 33.4 • n=7 Participants	57.2 pg/mL STANDARD_DEVIATION 28 • n=5 Participants
25-OH Vitamin D	35.3 ng/mL STANDARD_DEVIATION 12.7 • n=5 Participants	31.3 ng/mL STANDARD_DEVIATION 13.3 • n=7 Participants	33.3 ng/mL STANDARD_DEVIATION 13 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline,1,3,6,12 months

Population: The numbers analyzed reflect the number of participants evaluable at each time point.

One measure of bone turnover was urinary-NTX as a second void morning urine.

Outcome measures

Measure	Placebo n=39 Participants	Potassium Citrate n=37 Participants
Urinary-N-telopeptide Month 12	42.1 nml BCE/nmol creatinine Standard Deviation 13.9	41.6 nml BCE/nmol creatinine Standard Deviation 18.4
Urinary-N-telopeptide Baseline	47.2 nml BCE/nmol creatinine Standard Deviation 19.6	51.6 nml BCE/nmol creatinine Standard Deviation 25.8
Urinary-N-telopeptide Month 1	44.5 nml BCE/nmol creatinine Standard Deviation 22.5	47 nml BCE/nmol creatinine Standard Deviation 21
Urinary-N-telopeptide Month 3	50.8 nml BCE/nmol creatinine Standard Deviation 21.2	40.5 nml BCE/nmol creatinine Standard Deviation 24.5
Urinary-N-telopeptide Month 6	40.4 nml BCE/nmol creatinine Standard Deviation 11.6	41.6 nml BCE/nmol creatinine Standard Deviation 18.4

PRIMARY outcome

Timeframe: Baseline,1,3,6,12 months

Population: The numbers analyzed reflect the number of participants evaluable at each time point.

One measure of bone turnover was P1NP as a morning lab draw.

Outcome measures

Measure	Placebo n=41 Participants	Potassium Citrate n=42 Participants
P1NP (Amino-terminal Propeptide of Type I Procollagen) Baseline	50.6 micrograms/L Standard Deviation 20.1	55.5 micrograms/L Standard Deviation 23.5
P1NP (Amino-terminal Propeptide of Type I Procollagen) Month 6	46.0 micrograms/L Standard Deviation 15.0	43.2 micrograms/L Standard Deviation 12.8
P1NP (Amino-terminal Propeptide of Type I Procollagen) Month 12	45.5 micrograms/L Standard Deviation 16.5	42.4 micrograms/L Standard Deviation 13.6
P1NP (Amino-terminal Propeptide of Type I Procollagen) Month 1	48.9 micrograms/L Standard Deviation 19.2	48.1 micrograms/L Standard Deviation 16.9
P1NP (Amino-terminal Propeptide of Type I Procollagen) Month 3	48.7 micrograms/L Standard Deviation 18.3	43.5 micrograms/L Standard Deviation 15.5

SECONDARY outcome

Timeframe: 1 year

BMD was performed at lumbar spine, total hip and femoral neck using dual-energy X-ray Absorptiometry (DXA) Hologic; Bedford, Massachusetts.

Outcome measures

Measure	Placebo n=41 Participants	Potassium Citrate n=42 Participants
Number of Participants With Stable Bone Mineral Density (BMD) Over 12 Months at All Sites.	41 Participants	42 Participants

Adverse Events

Potassium Citrate

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Potassium Citrate n=42 participants at risk Potassium Citrate 20 meq twice daily potassium citrate: 20 meq by mouth in capsule form twice daily	Placebo n=41 participants at risk Placebo potassium citrate: 20 meq by mouth in capsule form twice daily
Musculoskeletal and connective tissue disorders Traumatic Ankle Fracture	0.00% 0/42	2.4% 1/41
Metabolism and nutrition disorders Hyperkalemia	4.8% 2/42	14.6% 6/41
Gastrointestinal disorders Gastrointestinal Symptoms	19.0% 8/42	9.8% 4/41

Additional Information

Assistant Professor of Medicine

Weill Medical College

Phone: 212-746-1670

Email: sinhana@med.cornell.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place