NCT02731820: ACAROS

Efficacy of Potassium Citrate in the Treatment of Postmenopausal Osteopenia

Completed NA Results posted Last updated 12 November 2019

What this trial tests

NA trial testing Potassium citrate in Osteopenia in 40 participants. Completed in 30 September 2017.

Timeline

1 September 2015

Primary endpoint
30 August 2017

30 September 2017

Quick facts

Lead sponsor	Istituto Ortopedico Rizzoli
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	prevention
Enrollment	40
Start date	1 September 2015
Primary completion	30 August 2017
Estimated completion	30 September 2017
Sites	1 location across Italy

Drugs / interventions tested

• Potassium citrate — full drug profile →
• Placebo
• Vitamin D3 (cholecalciferol) — full drug profile →
• Calcium carbonate (calcium carbonate) — full drug profile →

Conditions studied

• Osteopenia — all drugs for Osteopenia →
• Bone Disease, Metabolic — all drugs for Bone Disease, Metabolic →

Sponsor

Istituto Ortopedico Rizzoli — full company profile →

Who can join

Eligibility, female only, with Osteopenia or Bone Disease, Metabolic. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Changes in Serum Level of Carboxyterminal Cross-linked Telopeptide of Type I Collagen (CTX); Over Time, i.e. Baseline, 3 Months, 6 Months. Primary · Baseline (T0), 3 months (T3) 6 months (T6)

Carboxyterminal cross-linked telopeptide of type I collagen (CTX) is a degradation product of the type I collagen; it is considered as a marker of bone resorption. The concentration of CTX (µg/L) will be measured at T0, T3, and T6 on serum samples (fasting morning samples) using commercially available reagents and following the manufacturer's protocol. At the end of the study, the results will be aggregated as mean ± standard of the mean, median and min-max range. Data will be statistically analyzed in order to compare the activity of Potassium citrate versus Placebo (unpaired analysis) and t

Baseline (T0)

Group	Value	95% CI
Treatment Group, Potassium Citrate	0.64	± 0.08
Control Group, Placebo	0.64	± 0.05

3 months (T3)

Group	Value	95% CI
Treatment Group, Potassium Citrate	0.63	± 0.08
Control Group, Placebo	0.56	± 0.05

6 months (T6)

Group	Value	95% CI
Treatment Group, Potassium Citrate	0.53	± 0.08
Control Group, Placebo	0.54	± 0.06

Changes in Serum Levels of "Tartrate-resistant Acid Phosphatase 5b Isoenzyme" (TRAcP5b) Over Time, i.e. Baseline, 3 Months, 6 Months. Primary · Baseline (T0), 3 months (T3) 6 months (T6)

Tartrate-resistant acid phosphatase 5b isoenzyme" (TRAcP5b) is a specific product of osteoclasts; it is considered as a marker of bone resorption. The concentration of TRAcP5B (U/L) will be measured at T0, T3, and T6 on serum samples (fasting morning samples) using commercially available reagents and following the manufacturer's protocol. At the end of the study, the results will be aggregated as mean ± standard of the mean, median and min-max range. Data will be statistically analyzed in order to compare the activity of Potassium Citrate versus Placebo (unpaired analysis) and to evaluate the

Baseline (T0)

Group	Value	95% CI
Treatment Group, Potassium Citrate	2.35	± 0.20
Control Group, Placebo	2.64	± 0.22

3 months (T3)

Group	Value	95% CI
Treatment Group, Potassium Citrate	2.79	± 0.27
Control Group, Placebo	2.85	± 0.22

6 months (T6)

Group	Value	95% CI
Treatment Group, Potassium Citrate	2.69	± 0.29
Control Group, Placebo	2.25	± 0.14

Changes in Serum Levels of "N-terminal Propeptide of Type I Procollagen" (P1NP) Over Time, i.e. Baseline, 3 Months, 6 Months. Primary · Baseline (T0), 3 months (T3) 6 months (T6)

N-terminal propeptide of type I procollagen" (P1NP) is a product of the conversion of procollagen to collagen; it is considered as a marker of bone formation. The concentration of P1NP (pg/L) will be measured at T0, T3, and T6 on serum samples (fasting morning samples) using commercially available reagents and following the manufacturer's protocol. At the end of the study, the results will be aggregated as mean ± standard of the mean, median and min-max range. Data will be statistically analyzed in order to compare the activity of Potassium citrate versus Placebo (unpaired analysis) and to eva

Baseline (T0)

Group	Value	95% CI
Treatment Group, Potassium Citrate	17.45	± 1.48
Control Group, Placebo	18.82	± 1.73

3 months (T3)

Group	Value	95% CI
Treatment Group, Potassium Citrate	16.24	± 1.60
Control Group, Placebo	18.39	± 1.75

6 months (T6)

Group	Value	95% CI
Treatment Group, Potassium Citrate	14.97	± 1.51
Control Group, Placebo	16.77	± 1.89

Changes in Serum Levels of "Bone-specific Alkaline Phosphatase" (BAP) Over Time, i.e. Baseline, 3 Months, 6 Months. Primary · Baseline (T0), 3 months (T3) 6 months (T6)

Bone-specific alkaline phosphatase (BAP) is a specific product of osteoblasts; it is considered as a marker of bone formation. The concentration of BAP (µg/L) will be measured at T0, T3, and T6 on serum samples (fasting morning samples) using commercially available reagents and following the manufacturer's protocol. At the end of the study, the results will be aggregated as mean ± standard of the mean, median and min-max range. Data will be statistically analyzed in order to compare the activity of Potassium citrate versus Placebo (unpaired analysis) and to evaluate the effect of Potassium Cit

Baseline (T0)

Group	Value	95% CI
Treatment Group, Potassium Citrate	21.89	± 1.67
Control Group, Placebo	20.36	± 1.17

3 months (T3)

Group	Value	95% CI
Treatment Group, Potassium Citrate	19.81	± 1.67
Control Group, Placebo	18.27	± 1.00

6 months (T6)

Group	Value	95% CI
Treatment Group, Potassium Citrate	16.83	± 1.37
Control Group, Placebo	15.79	± 1.09

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events were recorded at 3 months and 6 months. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Treatment Group

Serious: 0/20 (0%)

Deaths: 0/20

Control Group, Placebo

Serious: 0/20 (0%)

Deaths: 0/20

Other adverse events (2 terms — click to expand)

Reaction	System	Treatment Group	Control Group, Placebo
Constipation	Gastrointestinal disorders	—	—
Gastritis	Gastrointestinal disorders	—	—

Data from ClinicalTrials.gov NCT02731820 adverse events section.

Sponsor's own description

The purpose of this study is to investigate whether the use of alkali compounds, i.e. potassium citrate (K3C6H5O7, hereinafter KCitr) is effective in preventing the progression of osteopenia.

A randomized clinical trial (RCT, placebo-controlled, double-blind) has been planned to evaluate the effect of the daily administration of KCitr (3 g/die, K 30 mEq).

The efficacy will be evaluated by comparing the circulating levels of bone turnover markers at the baseline and after the treatment (3, 6 months).

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Potassium Citrate Supplementation Decreases the Biochemical Markers of Bone Loss in a Group of Osteopenic Women: The Results of a Randomized, Double-Blind, Placebo-Controlled Pilot Study.
   Granchi D, Caudarella R, Ripamonti C, Spinnato P, et al · · 2018 · cited 16× · PMID 30213095 · DOI 10.3390/nu10091293
2. The effect of non-pharmacological interventions on bone health among patients with low bone mass: a systematic review and meta-analysis.
   Na X, Yang Y, Yang H, Chen Z, et al · · 2025 · PMID 41450587 · DOI 10.3389/fendo.2025.1612739