Phase 4 Completed N=83 Randomized Triple-blind Treatment

The Effects of Potassium Citrate on Bone Metabolism

Bone Diseases, Metabolic · Osteoporosis, Postmenopausal

Source: ClinicalTrials.gov NCT00357331 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2017

Primary outcomePrimary: Urinary-N-telopeptide — 47.2; 51.6; 44.5; 47 nml BCE/nmol creatinine

◆ Published Evidence

No publication linked

No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.

Summary

Skeletal buffering of chronic acid loads may contribute to a significant amount of bone loss over time. Evidence from a few small short-term studies suggests that basic compounds, namely potassium citrate and potassium bicarbonate may reduce bone loss and improve bone density. The purpose of this study is to evaluate the effects of potassium citrate on bone metabolism. We hypothesize that administration of potassium citrate to postmenopausal women with osteopenia will reduce bone resorption and improve bone mineral density. Postmenopausal women with osteopenia (T score between -1.0 and -2.5) and no history of fracture will be randomized to either daily potassium citrate or placebo for one year. Primary outcomes will be markers of bone turnover, which will be measured over 12 months. Secondary outcomes will be bone mineral density, compliance, and adverse events.

Outcome Measures

Outcome	Result	p-value
PRIMARY Urinary-N-telopeptide	47.2; 51.6; 44.5; 47; 50.8; 40.5	—
PRIMARY P1NP (Amino-terminal Propeptide of Type I Procollagen)	50.6; 55.5; 48.9; 48.1; 48.7; 43.5	—
SECONDARY Number of Participants With Stable Bone Mineral Density (BMD) Over 12 Months at All Sites.	41; 42	—

Eligibility Criteria

Inclusion Criteria

Postmenopausal women, more than 2 years post menopause
Osteopenia, defined as a T score at the lumbar spine or total hip between -1.0 and -2.5
No history of prior fragility fracture

Exclusion criteria

Renal insufficiency
Use of potassium sparing diuretics
Use of potassium supplements
Hyperkalemia
Secondary causes of osteoporosis or metabolic bone disease
Delayed gastric emptying
esophageal compression, intestinal obstruction or stricture
use of anticholinergic medication
active urinary tract infection.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00357331). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.