Efficacy of Potassium Citrate in the Treatment of Postmenopausal Osteopenia

NCT02731820 | Completed Results DMC

• 2 other identifiers: 6013_IOR1676
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Osteopenia; Bone Disease, Metabolic

Keywords

potassium citrate

Outcome Measures

Primary Outcomes (4)

• Changes in Serum Level of Carboxyterminal Cross-linked Telopeptide of Type I Collagen (CTX); Over Time, i.e. Baseline, 3 Months, 6 Months.

  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 to evaluate the effect of Potassium Citrate and Placebo over time (paired analysis). Differences will be considered to be statistically significant for p-value \<0.05.

  Baseline (T0), 3 months (T3) 6 months (T6)

• Changes in Serum Levels of "Tartrate-resistant Acid Phosphatase 5b Isoenzyme" (TRAcP5b) Over Time, i.e. Baseline, 3 Months, 6 Months.

  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 effect of Potassium Citrate and Placebo over time (paired analysis). Differences will be considered to be statistically significant for p-value \<0.05.

  Baseline (T0), 3 months (T3) 6 months (T6)

• Changes in Serum Levels of "N-terminal Propeptide of Type I Procollagen" (P1NP) Over Time, i.e. Baseline, 3 Months, 6 Months.

  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 evaluate the effect of Potassium Citrate and Placebo over time (paired analysis). Differences will be considered to be statistically significant for p-value \<0.05.

  Baseline (T0), 3 months (T3) 6 months (T6)

• Changes in Serum Levels of "Bone-specific Alkaline Phosphatase" (BAP) Over Time, i.e. Baseline, 3 Months, 6 Months.

  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 Citrate and Placebo over time (paired analysis). Differences will be considered to be statistically significant for p-value \<0.05.

  Baseline (T0), 3 months (T3) 6 months (T6)

Study Arms (2)

Treatment group

EXPERIMENTAL

Potassium citrate Calcium carbonate Vitamin D3

Dietary Supplement: Potassium citrate; Dietary Supplement: Vitamin D3; Dietary Supplement: Calcium carbonate

Control group, Placebo

PLACEBO COMPARATOR

Placebo (Excipients) Calcium carbonate Vitamin D3

Dietary Supplement: Placebo; Dietary Supplement: Vitamin D3; Dietary Supplement: Calcium carbonate

Interventions

Potassium citrate DIETARY_SUPPLEMENT

Kcitr 3.064 milligrams daily in two tablets by mouth (1.032 milligrams every 12 hours)

Treatment group

Placebo DIETARY_SUPPLEMENT

Excipients: 3.064 milligrams daily in two tablets by mouth (1.032 milligrams every 12 hours)

Control group, Placebo

Vitamin D3 DIETARY_SUPPLEMENT

400 IU/die Vitamin D3 daily by mouth

Also known as: Cholecalciferol

Control group, Placebo; Treatment group

Calcium carbonate DIETARY_SUPPLEMENT

500 mg/die calcium carbonate daily by mouth

Control group, Placebo; Treatment group

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Postmenopausal women, more than 5 years post menopause
• Osteopenia (T-score \< -1 and \> -2.5)
• Low risk of fracture (FRAX: \< 20 major osteoporotic; \< 3 hip fracture)

You may not qualify if:

• Hyperkalemia
• Renal insufficiency
• Nephrolithiasis
• Use of potassium sparing diuretics
• Use of potassium supplements
• Use of therapies influencing bone metabolism (e.g. corticosteroids, thiazide diuretics, aromatase inhibitors, estrogens)
• Use of protonic pump inhibitors
• Current or recent use of bisphosphonates (stopped less than three years prior to the start of the study)
• Gastrointestinal disorders that hamper nutrient absorption;
• Mental or psychiatric disorders that preclude the possibility of correctly adhering to the protocol

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead

Study Sites (1)

Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

Location

Related Publications (5)

• Arnett TR. Acidosis, hypoxia and bone. Arch Biochem Biophys. 2010 Nov 1;503(1):103-9. doi: 10.1016/j.abb.2010.07.021. Epub 2010 Jul 23.

  PMID: 20655868 BACKGROUND

• Lambert H, Frassetto L, Moore JB, Torgerson D, Gannon R, Burckhardt P, Lanham-New S. The effect of supplementation with alkaline potassium salts on bone metabolism: a meta-analysis. Osteoporos Int. 2015 Apr;26(4):1311-8. doi: 10.1007/s00198-014-3006-9. Epub 2015 Jan 9.

  PMID: 25572045 BACKGROUND

• Hanley DA, Whiting SJ. Does a high dietary acid content cause bone loss, and can bone loss be prevented with an alkaline diet? J Clin Densitom. 2013 Oct-Dec;16(4):420-5. doi: 10.1016/j.jocd.2013.08.014. Epub 2013 Oct 2.

  PMID: 24094472 BACKGROUND

• Jehle S, Hulter HN, Krapf R. Effect of potassium citrate on bone density, microarchitecture, and fracture risk in healthy older adults without osteoporosis: a randomized controlled trial. J Clin Endocrinol Metab. 2013 Jan;98(1):207-17. doi: 10.1210/jc.2012-3099. Epub 2012 Nov 15.

  PMID: 23162100 BACKGROUND

• Granchi D, Caudarella R, Ripamonti C, Spinnato P, Bazzocchi A, Massa A, Baldini N. 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. Nutrients. 2018 Sep 12;10(9):1293. doi: 10.3390/nu10091293.

  PMID: 30213095 RESULT

Related Links

• Istituto Ortopedico Rizzoli\_Home Page

MeSH Terms

Conditions

Bone Diseases, Metabolic

Interventions

Potassium Citrate; Cholecalciferol; Calcium Carbonate

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Citric Acid; Citrates; Tricarboxylic Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids; Calcium Compounds; Inorganic Chemicals; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Minerals

Results Point of Contact

• Title: Director of Clinical Trials
• Organization: Istituto Ortopedico Rizzoli

ctc@ior.it

+39 051.6366392

Study Officials

• Nicola Baldini, MD, Prof.

  Istituto Ortopedico Rizzoli

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Professor

Study Record Dates

• First Submitted: March 31, 2016
• First Posted: April 8, 2016
• Study Start: September 1, 2015
• Primary Completion: August 30, 2017
• Study Completion: September 30, 2017
• Last Updated: November 12, 2019
• Results First Posted: November 12, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)